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Chapter 2

Pharmacy Law
and Regulations

Chapter Objectives
Upon completion of Chapter 2, the pharmacy technician student will be able to
1. Differentiate between pharmacy ethics and legislation affecting the practice of pharmacy.
2. Compare and contrast the role of a pharmacist and a pharmacy technician in the medication delivery process.
3. Do the following regarding pharmacy law:
• List individuals who have prescribing authority with medications.
• Identify legislation that has affected the practice of pharmacy and explain how it affects daily pharmacy operations.
• Differentiate between the information found on a prescription drug manufacturer’s labeling and over-the-counter
(OTC) labeling.
• Differentiate between the various Drug Enforcement Agency (DEA) forms used when dealing with controlled
• Verify that a DEA number is valid.
• Discuss the regulatory requirements for dispensing controlled substances.
• State the conditions that medication does not need to be packaged in a child-resistant container.
• Express the importance of the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) and its impact on
patient care.
• Discuss the importance of the Health Insurance Portability and Accountability Act (HIPAA) and how it affects
patient information.
4. Identify various restricted drug programs and the processes associated with each in the filling of prescriptions for
that medication.
5. Discuss generic substitution, state-specific prescription transfer regulations, and the requirements of pharmacy
record retention.
6. Discuss pharmacy standards, including:
• Explain the importance of United States Pharmacopeia (USP) <795> on nonsterile compounding.
• Identify pharmacy standards, including the importance of USP <797> and its impact on infection control.
7. Discuss the regulatory requirements for the handling and disposing of hazardous waste.
8. Explain facility, equipment, and supply requirements required by the states’ Boards of Pharmacy and identify
required pharmacy resources.
9. Do the following regarding pharmacy regulatory agencies:
• List the various organizations that affect the practice of pharmacy and identify their roles in pharmacy.
• Explain the various types of drug recalls.
10. Discuss employee performance evaluation techniques.

80 Mosby’s Review for the Pharmacy Technician Certification Examination

PTCB Knowledge Domains ExCPT Knowledge Domains

2.1 Storage, handling, and disposal of hazardous 1.1 Overview of technician duties and general
substances and wastes (e.g., Material Safety Data information
Sheets [MSDS]) 1.1.1 The role of pharmacists and pharmacy
2.2 Hazardous substances exposure, prevention, and technicians
treatment (e.g., eyewash, spill kit, MSDS) 1.1.2 Functions that a technician may and may
2.4 Controlled substance documentation requirements not perform
for receiving, ordering, returning, loss or theft, and 1.1.4 Pharmacy security
destruction (DEA) 1.2 Controlled substances
2.5 Formula to verify the validity of a prescriber’s DEA 1.2.1 Difference among the controlled sub-
number (DEA) stances schedules
2.6 Record keeping, documentation, and record reten- 1.2.2 Refills, partial refills, filing, and prescription
tion (e.g., length of time prescriptions are main- transfers
tained on file)
1.2.3 Correct procedures for handling Schedule
2.7 Restricted drug programs and related prescription- V sales
processing requirements (e.g., thalidomide, isotret-
inoin, clozapine) 1.2.4 Controlled Substance Act
2.8 Professional standards related to data integrity, 1.2.5 DEA numbers
security, and confidentiality (e.g., HIPAA, backing 1.3 Other laws and regulations
up and archiving) 1.3.1 Federal Privacy Act
2.9 Requirement for consultation (e.g., OBRA ‘90) 1.3.2 Generic substitution (include brand vs. ge-
2.10 Food and Drug Administration’s (FDA’s) recall neric products)
classification 1.3.3 Professionals with prescribing authority
2.11 Infection control standards (e.g., laminar air flow, (and acronyms)
clean room, hand washing, cleaning counting 1.3.4 Child-resistant packaging
trays, countertop, and equipment) (OSHA, USP 1.3.5 Role of government agencies (e.g., BOP,
,795. and ,797.) DEA, FDA)
2.12 Record keeping for repackaged and recalled 1.3.6 Manufacture drug package labeling
products and supplies (The Joint Commission 1.3.7 OTC package labeling
[TJC], Boards of Pharmacy [BOP])
2.13 Professional standards regarding the roles
and responsibilities of pharmacists, pharmacy
technicians, and other pharmacy employees
2.15 Facility, equipment, and supply requirements • Medicare Prescription Drug, Improvement, and
(e.g., space requirements, prescription file Modernization Act of 2003
storage, cleanliness, reference materials) (TJC, • Drug Reimportation Reform: Currently being
USP, BOP) examined
• Orphan Drug Act: Promotes development of
pharmaceutical products with small markets
• Reducing the amount of time a drug is covered by
a patent, resulting in generic drugs becoming
available earlier
PHARMACEUTICAL, MEDICAL, • Revising the protocol for the development of
AND LEGAL DEVELOPMENTS THAT acquired immunodeficiency syndrome (AIDS)
OF PHARMACY • Process for converting prescription medications to
• American Society of Health-System Pharmacists’ over-the-counter (OTC) status
White Paper on Pharmacy Technicians • Allowing pharmacists to prescribe in specific
• Computerization: Method of processing, storing, situations
and transferring prescriptions • Third-party health care providers
• Online adjudication: Method of billing insurance • Automation
companies and ensuring payment for services • Electronic prescribing
• Faxes: Method of transmitting prescriptions and
medication orders from a physician’s office to a
• Personal digital assistants: Method of transmitting Ethics are defined as a study of standards and
prescriptions to a pharmacy moral judgment; it is a moral philosophy that is
Chapter 2 Pharmacy Law and Regulations 81

influenced by a particular group, society, philoso- profession in relationships with patients, health care
phy, religion, or profession. According to Remington professionals, and society.
The Science and Practice of Pharmacy ethics and laws • A pharmacy technician’s first consideration is to
are related in that both share the social purpose of ensure the health and safety of the patient and to
encouraging the right conduct. Whereas laws are use knowledge and skills to the best of his or her
enacted by the government to achieve a goal, ethics ability in serving others.
are embraced by a profession without the involve- • A pharmacy technician supports and promotes
ment of government. The American Pharmacists honesty and integrity in the profession, which
Association has issued a code of ethics for phar- includes a duty to observe the law, maintain
macy technicians. the highest moral and ethical conduct at all
times, and uphold the ethical principles of the
AMERICAN PHARMACISTS • A pharmacy technician assists and supports
ASSOCIATION’S CODE OF ETHICS the pharmacist in the safe, efficacious, and cost-
FOR PHARMACISTS effective distribution of health services and health
care resources.
• A pharmacy technician respects and values the
Pharmacists are health professionals who assist indi- abilities of pharmacists, colleagues, and other
viduals in making the best use of medications. This health care professionals.
code, prepared and supported by pharmacists, is • A pharmacy technician maintains competency in
intended to state publicly the principles that form the his or her practice and continually enhances his or
fundamental basis of the roles and responsibilities of her professional knowledge and expertise.
pharmacists. These principles, based on moral obli- • A pharmacy technician respects and supports
gations and virtues, are established to guide pharma- the confidentiality of a patient’s records and dis-
cists in relationships with patients, health profession- closes pertinent information only with proper
als, and society. authorization.
• A pharmacist respects the covenantal relationship • A pharmacy technician never assists in the dis-
between the patient and pharmacist. pensing, promoting, or distribution of medica-
• A pharmacist promotes the good of every patient tions or medical devices that are not of good
in a caring, compassionate, and confidential quality or do not meet the standards required
manner. by law.
• A pharmacist respects the autonomy and dignity • A pharmacy technician does not engage in any
of each patient. activity that will discredit the profession and will
• A pharmacist acts with honesty and integrity in expose, without fear or favor, illegal or unethical
professional relationships. conduct in the profession.
• A pharmacist maintains professional competence. • A pharmacy technician associates with and
• A pharmacist respects the values and abilities of engages in the support of organizations that
colleagues and other health professionals. promote the profession of pharmacy through
• A pharmacist serves individual, community, and the use and enhancement of pharmacy techni-
societal needs. cians.
• A pharmacist seeks justice in the distribution of
health resources.
FOR PHARMACY TECHNICIANS Pharmacists typically do the following:
• Fill prescriptions, verifying instructions from phy-
sicians on the proper amounts of medication to give
Pharmacy technicians are health care professionals to patients.
who assist pharmacists in providing the best possible • Check whether the prescription will interact nega-
care for patients. The principles of this code, which tively with other drugs that a patient is taking or
apply to pharmacy technicians working in any and conditions the patient has.
all settings, are based on the application and support • Instruct patients on how and when to take a pre-
of the moral obligations that guide the pharmacy scribed medicine.
82 Mosby’s Review for the Pharmacy Technician Certification Examination

• Advise patients on potential side effects they may • Assist pharmacist in scheduling and maintaining
experience from taking medicines. workflow.
• Advise patients about general health topics, such • Maintain knowledge of loss-prevention techniques.
as diet, exercise, and managing stress, and on
other issues, such as what equipment or supplies RESPONSIBILITIES OF
would be best for a health problem. INSTITUTIONAL PHARMACY
• Complete insurance forms and work with insur- TECHNICIANS
ance companies to be sure that patients get the • Rotate through all work areas of the pharmacy.
medicines they need. • Transport medications, drug-delivery devices, and
• Oversee the work of pharmacy technicians and other pharmacy equipment from the pharmacy to
pharmacists in training (interns). nursing units and clinics.
• Keep records and do other administrative tasks. • Pick up copies of physician orders, automated
• Teach other health care practitioners about proper medication administration records, and unused
medication therapies for patients. medications from the nursing units and return
The primary duty of a pharmacy technician is to them to the pharmacy.
assist the pharmacist. Pharmacy technicians provide • Fill patient medication cassettes.
technical assistance in the pharmacy but are not in- • Prepare medications and supplies for dispensing,
volved in professional judgmental duties, such as including the following:
counseling patients. The following sections list du- • Repackaging bulk medications, compounding
ties associated with community, institutional (e.g., ointments, creams, oral solutions, and other
hospital), and managed care pharmacy technicians. medications
• Compounding nonsterile preparations
RESPONSIBILITIES OF COMMUNITY • Preparing chemotherapeutic agents
PHARMACY TECHNICIANS • Compounding total parenteral nutrition (TPN)
• Help patients who are dropping off or picking up solutions
prescription orders. • Compounding large-volume and small-volume
• Enter prescription orders into the computer. intravenous (IV) mixtures
• Create a profile of the patient’s health and insur- • Packaging and preparing drugs being used in
ance information in the computer or update the clinical investigations
patient’s profile. • Preparing prescriptions for outpatients
• Assist the pharmacist, under direct supervision, in • Checking continuous unit-dose medications
the practice of pharmacy in accordance with local, • Controlling and auditing narcotics and stock
state, federal, and company regulations. substances
• Communicate with insurance carriers to obtain • Restocking crash carts
payment for prescription claims. • Assist pharmacists with entering medication or-
• At point of sale, verify that customers receive cor- ders into the computer system.
rect prescriptions. • Prepare inventories, order drugs and supplies
• Complete weekly distribution center medication from the storeroom, receive drugs, and stock
orders, place orders on shelves, and verify all as- shelves in various pharmacy locations.
sociated paperwork. • Screen telephone calls.
• Assist the pharmacist with filling and labeling • Perform monthly nursing unit inspections, main-
prescriptions. tain workload records, and collect quality assur-
• Prepare the pharmacy inventory. ance data.
• Screen telephone calls for the pharmacist. • Assist in training new employees.
• Communicate with prescribers and their agents to • Assist other pharmacy technicians.
obtain refill authorization. • Coordinate insurance billing, including third-
• Compound oral solutions, ointments, and party prescriptions.
creams. • Deliver unit dose to automated dispensing tech-
• Prepackage bulk medications. nology, such as a Pyxis machine.
• Maintain an awareness of developments in the • Triage telephone and window inquiries.
community and the pharmaceutical field that relate
to job responsibilities and integrate them into own RESPONSIBILITIES OF MANAGED
• Assist in training new employees. • Under the supervision of a pharmacist, perform
• Assist other pharmacy technicians. daily handling of ongoing pharmacy benefit
Chapter 2 Pharmacy Law and Regulations 83

telephone calls from members, pharmacy pro-

viders, and physicians. Adulteration
• Troubleshoot third-party prescription claims ques- • Consisting “in whole or in part of any filthy,
tions with an understanding of online rejections putrid, or decomposed substance”
and plan parameters. • “Prepared, packed, or held under unsanitary
• Develop and maintain an electronic service log conditions”
of all telephone calls with complete follow-up • Prepared in containers “composed, in whole
history. or in part, of any poisonous or deleterious
• Develop a trending report on the aforementioned substance”
service calls with an eye toward forecasting pos- • Containing unsafe color additives
sible trends in pharmacy service. • Claimed to be or represented as drugs recognized
• Provide as-needed telephone and administrative “in an official compendium” but differing in
support for the department. strength, quality, or purity of the drugs

• Labeling that is “false or misleading in any par-
Note: This review book examines federal laws af- ticular way”
fecting the practice of pharmacy. Federal law takes • Packaging that does not bear a label containing the
precedence over state law unless the state law is name and place of business of the manufacturer,
stricter than the federal law, in which case the state packer, or distributor or an accurate quantity
law takes precedence. Every pharmacy technician of contents or is not conspicuously and clearly
must be aware of the state laws affecting the prac- labeled with information required by the act
tice of pharmacy in his or her state. • Failure to carry a label indicating “Warning—
May be habit forming” if the product is habit
Each state determines the requirements for those in- • Failure to “bear the established name of the drug
dividuals permitted to prescribe medications within and in case it carries more than two or more ac-
the state. This prescribing authority may be limited tive ingredients, the quantities of the ingredients,
or restricted by the state. Individuals with prescrib- the amount of alcohol and also including—
ing authority include: whether active or not—the established name and
• Medical doctors (MDs) quantity of certain other substances described in
• Physician assistants (PAs) the act”
• Nurse practitioners (NPs) • Failure to label “adequate directions for use” or
• Dentists (DDS and DMDs; limited to prescribing “adequate warnings against use in certain patho-
dental medications) logical conditions”
• Optometrists (ODs) • Products that are “dangerous to health when used
• Osteopaths (DOs) in the dosage or manner or duration prescribed,
• Podiatrists (DPMs) recommended or suggested in the labeling”
• Veterinarians (DVMs; can only prescribe for
animals) Manufacturer Drug Labeling
The following information is required on all manu-
PURE FOOD AND DRUG ACT facturer’s drug labels:
OF 1906 • Name and place of business of manufacturer,
• Enacted in 1906 to prohibit the interstate transpor- packer, or distributor
tation or sale of adulterated and misbranded food • National Drug Code number
or drugs • Adequate directions for use
• No misleading statements
FOOD, DRUG, AND COSMETIC ACT • Statement of ingredients
OF 1938 (FDCA 1938) • Prominence of required label statements
• The U.S. Food and Drug Administration (FDA) • Spanish-language version of certain required
was created under FDCA 1938. statements
• Requires that all new drug applications be filed • Expiration date
with the FDA • Manufacturer lot or control numbers
• Clearly defined adulteration and misbranding of • Declaration of presence of FD&C Yellow No. 5 or
drugs and food products FD&C Yellow No. 6 in certain drugs for human use
84 Mosby’s Review for the Pharmacy Technician Certification Examination

• Declaration of presence of phenylalanine as a com- a prescription, but an OTC drug does not. Pre-
ponent of aspartame in OTC and prescription scription medications require the supervision of
drugs for human use a physician.
• Prescription drugs containing sulfites; required • Allows verbal prescriptions over the telephone
warning statements • Allows refills to be called in from a physician’s
• Labeling for systemic antibacterial drug products office
• Bar code label requirements
• Exceptions or alternatives to labeling requirements KEFAUVER-HARRIS AMENDMENT
for human drug products held by the Strategic OF 1962
National Stockpile • Requires all medications in the United States to be
pure, safe, and effective
Over-the-Counter Package Labeling • Established procedures for both drug applications
The FDA requires the following on all OTC packages: and investigational drugs
• Drug’s name and place of business of manufac- • Drug manufacturers are required to be responsible
turer, packer, or distributor of drugs and devices for Good Manufacturing Process
• National Drug Code number
• Established name of a drug PREVENTION AND CONTROL ACT
• Inactive ingredient OF 1970
• Content requirements The Drug Enforcement Agency (DEA) was created
• “Purpose” or “Purposes” followed by the general and placed under the supervision of the Department
pharmacologic category(ies) or the principal in- of Justice. Controlled substances are placed in one of
tended action(s) of the drug or, when the drug five schedules (classifications or categories) based on
consists of more than one ingredient, the general a potential for abuse and accepted medical use in the
pharmacologic categories or the principal intended United States.
actions of each active ingredient
• “Use” or “Uses,” followed by the indication(s) Drug Schedules
• “Warning” or “Warnings” and “Do not use” fol- Schedule I medications have no accepted medical use
lowed by all contraindications for use with the in the United States and possess an extremely high
product, including, “Ask a doctor before use if potential for abuse.
you have” (a particular condition), “Ask a doctor Examples of Schedule I narcotics:
or pharmacist before use if you are”(taking spe- • “Crack” cocaine
cific medications), “When using this product” • Crystal methamphetamine
followed by the side effects that the consumer • Ecstasy
may experience, “Stop use and ask a doctor if” • Hashish
followed by any signs of toxicity or other reac- • Hash oil
tions that would necessitate immediately discon- • Heroin
tinuing use of the product, a pregnancy and • Lysergic acid diethylamide (LSD)
breastfeeding warning, a “Keep out of reach of • Marijuana
children” warning, and an accidental overdose or • Mescaline
ingestion warning • Opium
• “Directions” followed by the directions for use • Phencyclidine palmitate (PCP)
• “Inactive ingredients” followed by a listing of the • Peyote
established name of each inactive ingredient • Psilocybin
• “Questions?” or “Questions or comments?” fol- • Rohypnol (“roofies”)
lowed by the telephone number of the manufac- Schedule II medications have a medical use but
turer to answer questions about the product possess a high abuse potential with severe psycho-
logical or physical dependency (Table 2-1).
DURHAM-HUMPHREY ACT OF 1951 Schedule III drugs have accepted medical use, and
An amendment to FDCA 1938 requiring all products the abuse potential is less than with Schedule I and II
to have adequate directions for use unless they con- drugs (Table 2-2).
tain the federal legend “Caution: Federal law prohib- Schedule IV preparations abuse potential is
its dispensing without a prescription.” less than with Schedule III drugs, but administra-
• Separated drugs into two categories: legend tion may lead to limited physical or psychological
and nonlegend (OTC). A legend drug requires dependence.
Chapter 2 Pharmacy Law and Regulations 85

TABLE 2-1  Examples of Schedule II Medications Schedule V medications abuse potential is less
BRAND NAME GENERIC NAME than with Schedule IV drugs; this schedule includes
Adderall amphetamine and dextroamphetamine exempt narcotics.
Amytal amobarbital
Cocaine cocaine Drug Enforcement Agency Registration
Codeine codeine • Every facility that dispenses controlled substances
Demerol meperidine must be registered with the DEA.
Dexedrine dextroamphetamine • The pharmacy registers with the DEA by submit-
Dilaudid hydromorphone
ting a DEA Form 224.
Dolophine methadone
• The pharmacy must renew this registration every
Duragesic fentanyl
Morphine sulfate morphine
3 years.
Numorphan oxymorphone
Ordering and Receipt
OxyContin oxycodone
Percocet acetaminophen and oxycodone • Schedule II medications are ordered by properly
Percodan aspirin and oxycodone completing a DEA Form 222 (a triplicate order
Ritalin methylphenidate form) or submitting it electronically.
Seconal secobarbital • It must be signed by the individual in whose name
the DEA registration is listed.

TABLE 2-2  Examples of Schedules III and IV Medications

Ambien zolpidem IV
Anexsia acetaminophen 1 hydrocodone III
Ativan lorazepam IV
Bontril phendimetrazine III
Butisol butabarbital IV
Cylert pemoline IV
Dalmane flurazepam IV
Fastin phentermine IV
Fioricet with Codeine acetaminophen 1 butalbital 1 caffeine 1 codeine IV
Fiorinal aspirin 1 butalbital 1 caffeine IV
Fiorinal with Codeine aspirin 1 butalbital 1 caffeine 1 codeine IV
Halcion triazolam IV
Klonopin clonazepam IV
Librium chlordiazepoxide IV
Lomotil diphenoxylate 1 atropine IV
Lorcet acetaminophen 1 hydrocodone III*
Lortab acetaminophen 1 hydrocodone III*
Phenobarbital phenobarbital IV
Restoril temazepam IV
Robitussin A-C guaifenesin 1 codeine IV
Soma with Codeine carisoprodol 1 codeine III
Sonata zaleplon IV
Stadol butorphanol IV
Talwin pentazocine IV
Talwin Nx pentazocine 1 naloxone IV
Tranxene clorazepate IV
Tussionex chlorpheniramine 1 hydrocodone III*
Tylenol with Codeine acetaminophen 1 codeine III
Valium diazepam IV
Vicodin acetaminophen 1 hydrocodone III*
Vicoprofen ibuprofen 1 hydrocodone III*
Xanax alprazolam IV

*Hydrocodone-containing products are being considered to be reclassified as Schedule II drugs.

86 Mosby’s Review for the Pharmacy Technician Certification Examination

• A DEA Form 222 is valid for only 60 days.

• A paper DEA Form 222 must be completed with a Retention of Drug Enforcement Agency
typewriter, pen, or indelible pencil. Records
• Only one item per line, with a maximum of 10 dif- • DEA records are maintained for a minimum of
ferent items per form, is permitted. 2 years, kept separately from other invoices, and
• The number of lines ordered must be totaled on kept readily retrievable.
the bottom of the form. • “Readily retrievable” means separated from
• Unused forms must be kept in a secure location in normal business records or easily identifiable
the pharmacy. by an asterisk, a red line, or another visual
• On receipt of medication, the number of packages identifier.
must be recorded on a retained copy of Form 222, • A red C must be stamped on Schedule III to V re-
and the form must be dated and signed by the cords (both prescriptions and medication invoices)
pharmacist (Figure 2-1). if they are filed with other invoices. They must be
• The pharmacist may not use ditto marks for the provided to a DEA representative within 72 hours
date or signature. after request.
• The invoice or packing slip, in addition to the
completed DEA Form 222, must be retained in a Defective DEA Form 222
secure location of the pharmacy for a minimum of • A form is considered defective if it is incomplete or
2 years. illegible or shows signs of alteration, erasure, or
Schedules III to V: change.
• Drugs in Schedules III, IV, and V may be ordered • Defective forms must be kept for a minimum of
by any method (written, faxed, or verbal). 2 years and be readily retrievable.
• After receipt, the invoice or packing slip must be
dated, signed, stamped with a red C, and retained Inventories
in a secure location in the pharmacy for a mini- • The initial inventory is a complete and accurate
mum of 2 years. inventory of all controlled substances before

See Reverse of PURCHASER'S No order form may be issued for schedule I and II substances unless a OMB APPROVAL
Copy for Instructions completed application form has been received. (21 CFR 1306-04). No. 1117-0010
To: (Name of Supplier) STREET ADDRESS
L CODE No. of
n Packages Received
e No. of Size of
No Packages Package Name of Items Received

Date issued DEA Registration No. Name and Address of Registrant


Registered no a No. of the Order Form



Figure 2-1  ​DEA Form 222.

Chapter 2 Pharmacy Law and Regulations 87

the opening of the first day of business for a

pharmacy. Verifying a Drug Enforcement Administration Number
• The biennial inventory is taken every 2 years after • The first letter is an A, B, F, or M.
initial inventory is taken. An exact count for Sched- • The second letter is the first letter of the physician’s
ule II and an estimated count for Schedule III to V last name when he or she applied for a DEA number.
drugs must be performed; records must be kept • Add the numbers in the first, third, and fifth posi-
for a minimum of 2 years. tions together.
• The perpetual inventory shows controlled sub- • Add the numbers in the second, fourth, and sixth
stances received by the facility, supplied to other positions together. Multiply the sum by 2.
locations, returned to the pharmacy, and dispensed • Add both sums of numbers together. The number
to patients. A perpetual inventory will show the in the last column farthest from the right should be
actual number of units of a drug at a particular the same as the seventh digit of the DEA number.
moment in time. For example, what should be the seventh digit in
Dr. Andrew Sheen’s DEA number if it begins with
Return of Controlled Substances BS452589?
• Controlled substances can be returned only between
Add 41218 5 14.
DEA registrants.
Add 51519 5 19; multiply 19 by 2 and get 38.
• The DEA Form 222 is the official document for the
Add 14 to 38 and get 52; the last number
transfer of Schedule II medications.
should be a 2.
Destruction of Outdated or Damaged Therefore, the correct DEA number for Dr. Andrew
Controlled Substances Sheen is BS4525892.
• A DEA Form 41 must be submitted to the DEA,
indicating the name, strength, and quantities of Filling of Controlled Substances
controlled substances; the date of destruction; the • Schedule II prescription can be either handwritten
method of destruction; and witnesses present for or computer generated but must be signed in ink
the destruction. by the physician with no allowable refills.
• A retail pharmacy may submit one DEA Form 41 • A partial filling is allowed if the remaining quan-
each year. tity is available to the patient within 72 hours.
• Hospitals may have “blanket authorization.” (Refer • A new prescription must be issued by the pre-
to Figure 2-2 for a sample DEA Form 41.) scriber if additional quantities are to be provided
after 72 hours.
Theft of Controlled Substances • The pharmacist should notify the physician if the
• After the discovery of a theft of controlled sub- balance cannot be provided to the patient.
stances, the pharmacy must notify the nearest
DEA diversion office, notify local police, and com- Emergency Filling of Schedule II Drug
plete a DEA Form 106. Prescriptions
• The pharmacy must send the original copy of the An oral prescription can be issued to a pharmacy
DEA Form 106 to the DEA and retain one copy for under the following conditions:
its records. Refer to Figure 2-3 for a sample DEA • Pharmacist must make a good-faith attempt to
Form 106. identify the physician.
• Prescription is limited to a quantity to treat the
Drug Enforcement Administration Numbers patient during this emergency period.
• A physician is required to have a DEA number if • Pharmacist must reduce order to writing.
he or she wishes to write prescriptions for con- • Physician must write a prescription for this emer-
trolled substances. gency quantity, and the pharmacy must receive it
• A DEA number consists of two letters and seven within 7 days of the oral order.
numbers assigned to a physician. • If the pharmacy does not receive the written pre-
• Institutions, such as hospitals and phar­macies, scription, the DEA must be notified immediately.
are required to have a DEA number if controlled
substances are dispensed from these locations. Schedule III to V Drugs
• A licensed practitioner of a hospital may be per- • A prescription may be handwritten or computer
mitted to use the institutional DEA number but generated by a physician’s office, but it must be
will be assigned a specific identifier. signed by the physician in ink.
88 Mosby’s Review for the Pharmacy Technician Certification Examination

Figure 2-2  ​DEA Form 41.

Chapter 2 Pharmacy Law and Regulations 89

Figure 2-2, cont’d

90 Mosby’s Review for the Pharmacy Technician Certification Examination

Figure 2-3  ​DEA Form 106.

Chapter 2 Pharmacy Law and Regulations 91

Figure 2-3, cont’d

92 Mosby’s Review for the Pharmacy Technician Certification Examination

• The physician’s office may telephone a Schedule

III to V prescription in to the pharmacy or may fax Electronic Prescriptions for Controlled
one, depending on state law. Substances
• Electronic prescriptions for Schedule III to V are Prescriptions for controlled substances in schedules
permitted. II, III, IV, and V may be transmitted electronically
• A patient may receive up to five refills within from a physician’s office to a pharmacy.
6 months of the date the prescription was written
if authorized. Transferring of Controlled Substance
• Partial fillings are permitted as long as refills Prescriptions
are indicated on the original prescription, refills The DEA allows transfer of the original prescription
do not exceed the total quantity prescribed information for Schedule III, IV, and V controlled
by the physician, and no partial filling occurs substances for the purpose of refill dispensing be-
after 6 months of the original date of the pre- tween pharmacies on a one-time basis. If pharmacies
scription. share a real-time online database, however, then the
prescription may be transferred up to the maximum
Exempt Narcotics (Select Schedule V number of refills permitted by the law. The following
Medications) and Pseudoephedrine- are requirements:
Containing Products 1. The transfer is communicated directly between
• Select cough and antidiarrheal prescription items two licensed pharmacists, and the transferring
can be purchased by an individual if permitted by pharmacist is responsible for the following:
state law. a. The word “Void” must be written on the face of
• The quantity dispensed must be in the original the invalidated prescription.
manufacturer’s container and must not exceed the b. On the reverse side of the invalidated pre-
quantity established by law. scription must be written the name, address,
• The purchaser must be at least 18 years of age and and DEA number of the pharmacy to which
must complete the Exempt Narcotic Book with the the prescription was transferred and the name
following information: date purchased, name of of the pharmacist receiving the prescription
purchaser, address of purchaser, name of product information.
and quantity purchased, price of transaction, and c. The date of the transfer and name of the phar-
pharmacist’s signature. macist transferring the prescription must be
• There is a limit of one container in a 48-hour recorded.
period. 2. The receiving pharmacist is responsible for the
Facsimile Prescriptions a. “Transfer” must be written on the face of the
A faxed prescription for a Schedule III, IV, or V drug transferred prescription.
may serve as the original prescription. The following b. The following information must be recorded:
situations are exceptions: (1) Date of issuance of the original prescription
• A narcotic Schedule II substance that is to be com- (2) Original number of refills authorized on the
pounded for direct administration to a patient by original prescription
parenteral, IV, intramuscular, subcutaneous, or (3) Date of the original dispensing
intraspinal infusion (4) Number of valid refills remaining and dates
• A Schedule II substance for a resident of a long- and locations of previous refills
term care facility (5) Pharmacy’s name, address, and DEA regis-
• A practitioner prescribing a Schedule II narcotic tration number and prescription number
substance for a patient in hospice care, as certified from which the prescription was transferred
by Medicare under Title XVIII or licensed by the (6) Name of the pharmacist who transferred
state, may transmit a prescription to the dispens- the prescription
ing pharmacy by fax regardless of whether the (7) Pharmacy’s name, address, and DEA registra-
patient resides in a hospice facility or other care tion number and prescription number from
setting. The practitioner’s agent may also transmit which the prescription was originally filled
the prescription to the pharmacy. The practitioner 3. The original and transferred prescription(s) must
will note on the prescription that it is for a hospice be maintained for a period of 2 years from the date
patient. of the last refill.
Chapter 2 Pharmacy Law and Regulations 93

• Patients may appear to be very talkative and

Types of Fraudulent Prescriptions therefore may prevent you from verifying the
• Legitimate prescription pads are stolen from phy- prescription.
sicians’ offices, and prescriptions are written for
fictitious patients. Prevention Techniques for Fraudulent Prescriptions
• Drug abusers may alter the physician’s prescrip- • Know the prescriber and his or her signature.
tion to obtain larger quantities of medications. • Know the prescriber’s DEA registration number.
• Drug abusers may have prescription pads from • Know the patient; check the date of when the pre-
legitimate physicians printed with a different call- scription was written.
back number that is answered by an accomplice to • If there is a discrepancy, the patient must have a
verify the prescription. plausible reason before the medication is dispensed.
• A drug abuser will call in prescriptions and give • Any time there is doubt, request proper identifi­
his or her own telephone number as a callback cation.
number. • If you believe that you have a forged, altered, or
• Computers may be used to create prescriptions for counterfeited prescription, do not dispense the
nonexistent physicians or to copy legitimate phy- medication; contact the local police.
sicians’ prescriptions. • If you discover a pattern of prescription abuses,
contact the state board of pharmacy (BOP) or the
Characteristics of Forged Prescriptions local DEA office.
• Prescription looks “too good”; the prescriber’s
handwriting is too legible. Prescription Monitoring Programs
• Quantities, directions, or dosages differ from usual In 2005, the federal National All Schedules Prescrip-
medical usage. tion Electronic Reporting Act was introduced. The
• The prescription does not comply with the accept- act established an electronic system for practitioner
able standard abbreviations or appears to be text- monitoring of the dispensing of controlled substances
book presentation. in Schedules II, III, and IV. The act would have re-
• The prescription appears to be photocopied. quired specific information to be reported, such as a
• Directions are written in full with no abbreviations. patient identifier, drug dispensed, and quantity dis-
• Prescriptions are written in different colored inks, pensed, as well as the prescriber and the dispenser.
different pens, or different handwriting. Although the act was never enacted, the majority of
• Zeroes are added to the quantities. states have enacted either this or similar legislation.

Signs Indicating a Prescription Was Not Issued for a POISON PREVENTION PACKAGING
Legitimate Medical Purpose ACT OF 1970
• The prescriber writes significantly more prescrip- The Poison Prevention Packaging Act of 1970 was en-
tions or in larger quantities compared with other acted to reduce accidental poisoning in children. The
practitioners in the area. act requires that most OTC and legend drugs be pack-
• The patient appears to be returning too frequently. aged in child-resistant containers. A child-resistant
For example, a prescription that should last for a container is one that cannot be opened by 80% of chil-
month is being refilled biweekly or more frequently. dren younger than 5 years but can be opened by 90%
• The prescriber writes prescriptions for antagonis- of adults.
tic drugs, such as stimulants and depressants
simultaneously. Exceptions for Child-Resistant Containers
• The patient is presenting prescriptions written in • Single-time dispensing of product in noncompli-
the names of other people. ant container as ordered by the prescriber
• A number of people appear simultaneously or • Single-time or blanket dispensing of product in
within a short time bearing similar prescriptions noncompliant container as requested by patient or
from the same physician. customer in a signed statement
• “Strangers,” individuals who are not regular resi- • One noncompliant size of the OTC product for
dents of the community, show up with prescrip- elderly or disabled patients provided that the pack-
tions from the same physician. age contains the warning “This Package for House-
• The medication prescribed is not within the scope holds Without Young Children” or “Package Not
of practice of the doctor. Child Resistant”
94 Mosby’s Review for the Pharmacy Technician Certification Examination

• Drugs dispensed to institutionalized patients, pro- chemicals to become familiar with the format and
vided that these drugs are to be administered by understand the contents of the SDSs.
an employee of an institution
• Medications not requiring child-resistant containers: Section 1: Identification
• Betamethasone with no more than 12.6 mg per This section identifies the chemical on the SDS as
package well as the recommended uses. It also provides the
• Erythromycin ethylsuccinate tablets in pack- essential contact information of the supplier.
ages containing no more than 16 g
• Inhalation aerosols Section 2: Hazards Identification
• Mebendazole tablets with no more than 600 mg This section identifies the hazards of the chemical
per package presented on the SDS and the appropriate warning
• Methylprednisolone tablets with no more than information associated with those hazards.
85 mg per package
• Oral contraceptives taken cyclically in the man- Section 3: Composition/Information on Ingredients
ufacturer’s dispensing package This section identifies the ingredient(s) contained in
• Pancrelipase preparations the product indicated on the SDS, including impuri-
• Powdered anhydrous cholestyramine ties and stabilizing additives. This section includes
• Powdered colestipol up to 5 g per packet information on substances, mixtures, and all chemi-
• Prednisone tablets with no more than 105 mg cals for which a trade secret is claimed.
per package
• Sodium fluoride tablets with no more than Section 4: First Aid Measures
264 mg of sodium fluoride per package ​This section describes the initial care that should be
• Sublingual and chewable isosorbide dinitrate in given by untrained responders to an individual who
doses of 10 mg or less has been exposed to the chemical.
• Sublingual nitroglycerin tablets
Section 5: Fire Fighting Measures
OCCUPATIONAL SAFETY AND This section provides recommendations for fighting a
HEALTH ACT OF 1970 fire caused by the chemical.
• Created the Occupational Safety and Health
Administration (OSHA) Section 6: Accidental Release Measures
• Ensures a safe and healthful workplace for all This section provides recommendations on the ap-
employees propriate response to spills, leaks, or releases, includ-
• Requires a reporting system for job-related inju- ing containment and cleanup practices to prevent or
ries and illness minimize exposure to people, properties, or the envi-
• Attempts to reduce hazards in the workplace and ronment. It may also include recommendations dis-
conduct audits to ensure compliance with the Act tinguishing between responses for large and small
• Addresses air contaminants, flammable and com- spills when the spill volume has a significant impact
bustible liquids, eye and skin protection, and haz- on the hazard.
ard communication standards
• OSHA requires use of Safety Data Sheets (SDSs), Section 7: Handling and Storage
which are to be provided by the seller of a particu- This section provides guidance on the safe handling
lar product to the purchaser. practices and conditions for safe storage of chemicals.
• Established universal precautions
Section 8: Exposure Controls and Personal Protection
Safety Data Sheets ​This section indicates the exposure limits, engineer-
The Hazard Communication Standard, revised in ing controls, and personal protective measures that
2012, requires that the chemical manufacturer, dis- can be used to minimize worker exposure.
tributor, or importer provide SDSs (formerly MSDSs
or Material Safety Data Sheets) for each hazardous Section 9: Physical and Chemical Properties
chemical to users to communicate information on This section identifies physical and chemical proper-
these hazards. The information contained in the SDS ties associated with the substance or mixture.
is largely the same as the MSDS, except now the
SDSs are required to be presented in a consistent Section 10: Stability and Reactivity
user-friendly, 16-section format. This brief provides This section describes the reactivity hazards of the
guidance to help workers who handle hazardous chemical and the chemical stability information.
Chapter 2 Pharmacy Law and Regulations 95

This section is broken into three parts: reactivity, Section 14: Transport Information (Not Mandatory)
chemical stability, and other. ​This section provides guidance on classification in-
formation for shipping and transporting of hazard-
Section 11: Toxicological Factors ous chemical(s) by road, air, rail, or sea.
​This section identifies toxicologic and health effects
information or indicates that such data are not Section 15: Regulatory Information (Not Mandatory)​
available. This section identifies the safety, health, and environ-
mental regulations specific for the product that is not
Section 12: Ecological Information (Not Mandatory) indicated anywhere else on the SDS.
​This section provides information to evaluate the
environmental impact of the chemical(s) if it were Section 16: Other Information
released to the environment. ​This section indicates when the SDS was prepared or
when the last known revision was made. The SDS
Section 13: Disposal Considerations (Not Mandatory) may also state where the changes have been made to
This section provides guidance on proper the previous version.
disposal practices, recycling or reclamation of According to the Hazard Communication, the new
the chemical(s) or its container, and safe handling SDS requirements will be phased in over the next
practices. several years as outlined below:


December 1, 2013 Train employees on the new label elements and (SDS) Employers
June 1, 2015* Compliance with all modified provisions of this final rule, Chemical manufacturers,
December 1, 2015 except: “The Distributor shall not ship containers labeled importers, distributors,
by the chemical manufacturer or importer unless it is a and employers
GHS label.”
June 1, 2016 Update alternative workplace labeling and hazard Employers
communication program as necessary and provide
additional employee training for newly identified physical
or health hazards.
Transition Period to the May comply with 29 CFR 1910.1200 (the final standard), the Chemical manufacturers,
effective completion dates current standard, or both importers, distributors,
noted above and employers

*All requirements must be met except the component regarding the distributor, which takes place on December 1, 2015.
CFR, Code of Federal Regulations; GHS, Globally Harmonized System of Classification and Labeling of Chemicals.

DRUG LISTING ACT OF 1972 • Change or delete any information that is incorrect,
Each drug is assigned a specific 11-digit number irrelevant, untimely, or incomplete
to identify it. This number is known as an NDC • Sue the government for violations of the act, includ-
(National Drug Code) number. The first five digits ing allowing others unauthorized access to your
identify the manufacturer, the next four digits iden- personal information
tify the drug product, and the final two digits repre- Similar to the Freedom of Information Act, the Privacy
sent the package size and packaging. Act provides a legal process for accessing personal
The Privacy Act of 1974 regulates what personal in- ORPHAN DRUG ACT OF 1983
formation the federal government can collect about • Orphan drugs are medications for treatment of
private individuals and how that information can diseases or conditions of which there are fewer
be used. than 200,000 cases in the world.
Under the Privacy Act, people have the right to: • It provides tax incentives and exclusive licensing
• See the information the government has about of products for manufacturers to develop and
you, subject to the act’s exemptions market orphan medications.
96 Mosby’s Review for the Pharmacy Technician Certification Examination


AND PATENT TERM RESTORATION) OBRA ‘90 required states to establish drug use review
ACT OF 1984 programs consisting of three essential components:
• Encouraged the creation of both generic and (1) prospective drug use review, (2) retrospective
new medications by streamlining the process for drug use review, and (3) educational programs.
generic drug approval and by extending patent The first pharmaceutical service required as a part
licenses of prospective drug use review is screening for po-
tential drug therapy problems before a prescription is
PRESCRIPTION DRUG MARKETING filled and delivered to the patient. This screening re-
ACT OF 1987 quires the pharmacist to review the drug therapy for
• Prohibits the reimportation of a drug into the therapeutic duplication, drug–disease contraindica-
United States by anyone except the manufacturer tions, drug–drug interactions (including OTC medi-
• Forbids the sale or distribution of samples to cations), incorrect drug dosage or duration of drug
anyone other than those licensed to prescribe treatment, drug–allergy interactions, and clinical
them abuse or misuse.
• Requires the following label to appear on all med- The second pharmaceutical service required as a part
ications to be administered to animals: “Caution: of prospective drug use review is patient counseling.
Federal law restricts this drug to use by or on an The pharmacist must offer to discuss with the patient
order of a licensed veterinarian” matters that the pharmacist, in the exercise of his or her
professional judgment, deems significant. Although
OMNIBUS BUDGET RECONCILIATION OBRA ‘90 establishes rules applicable to Medicaid pa-
ACT OF 1987 tients, most states have included this mandate to cover
The Omnibus Budget Reconciliation Act of 1987 all patients. It thus makes good sense in pharmacy prac-
(OBRA ‘87) established extensive revisions to Medi- tice to ensure that all individuals are provided the best
care and Medicaid Conditions of Participation regard- in health care services. At a minimum, the pharmacist
ing long-term care facilities and pharmacy. These must initiate a dialogue with the patient and offer to
include the following: discuss the following items:
• Each resident’s drug regimen must be free of • The name and description of the medication
unnecessary medications. • The route, dosage form, dosage, route of adminis-
• Antipsychotic drugs are not to be used unless the tration, and duration of drug therapy
patient has a specific condition. • Special directions and precautions for preparation,
• Patients requiring antipsychotic medication must administration, and use by the patient
be documented as having been diagnosed with a • Common severe side or adverse effects or interac-
condition that warrants its use. tions and therapeutic contraindications that may
• Patients receiving antipsychotic medication must be encountered, including their avoidance, and
receive gradual dose tapering. Behavioral modifi- the action required if they occur
cation and drug holidays are used to see if the • Techniques for self-monitoring of the drug therapy
medication may be discontinued. • Proper storage
• Residents are to be free of any significant medica- • Prescription refill information and action to be
tion errors. taken in the event of a missed dose
• Routine and emergency drugs must be provided OBRA ‘90 also requires the pharmacist to make a
to patients. reasonable effort to obtain, record, and maintain pa-
• Long-term care facilities must have the services of tient information. The patient profiles must contain,
a consultant pharmacist. at a minimum, general information that includes the
• Medications must be labeled according to accepted patient’s (1) name, (2) address, (3) telephone number,
professional principles. (4) date of birth, and (5) gender. Last, each patient
• Medications must be stored in locked compart- profile must contain the patient’s individual history
ments at the proper temperature according to both if it is deemed significant.
federal and state laws. The second essential component of a state’s drug
use review program, as required by OBRA ’90, is ret-
ANABOLIC STEROID CONTROL ACT rospective drug use review. Retrospective drug use
OF 1990 review requires “ongoing periodic examination of
• Enacted harsher penalties for the abuse of anabolic claims data and other records in order to identify pat-
steroids and their misuse by athletes terns of fraud, abuse, gross overuse, or medically
Chapter 2 Pharmacy Law and Regulations 97

unnecessary care and implements corrective action • Have Good Manufacturing Practices followed by
when needed.” Briefly, the third and final component the manufacturer
of a state’s drug use review program is educational
programming. The educational objective is to im- HEALTH INSURANCE PORTABILITY
prove prescribing and dispensing practices. AND ACCOUNTABILITY ACT OF 1996
The purpose of the Health Insurance Portability and
FOOD AND DRUG ADMINISTRATION Accountability Act (HIPAA) was to improve porta-
SAFE MEDICAL DEVICES ACT bility and continuity of health coverage in the group
OF 1990 and individual markets; combat waste, fraud, and
• All medical devices are to be tracked and records abuse in health insurance and health care delivery;
maintained for durable medical equipment. promote the use of medical savings accounts;
improve access to long-term care services and cov-
RESOURCE CONSERVATION erage; and simplify the administration of health
• The Resource Conservation and Recovery Act • Requires that health care providers ensure that
(RCRA) is a U.S. law that provides, in broad terms, patient confidentiality be maintained
the general guidelines for the waste management • Establishes conditions on the use and the disclo-
program envisioned by Congress. sure of protected health information (PHI) and
• Hazardous waste is a waste with properties that requires patient notification on how their PHI will
make it dangerous or potentially harmful to human be used
health or the environment. In regulatory terms, • Patients are entitled to a complete discussion
RCRA hazardous wastes fall into two categories: of health care options from the health care
• Listed wastes, which appear on one of the four provider.
hazardous wastes lists established by Environ- • Patients may request that confidential communi-
mental Protection Agency (EPA) regulations: cation is made in a manner that they think is
the F-list (nonspecific source wastes), K-list appropriate.
(source-specific wastes), P-list, and U-list (dis- • Every organization must have a written privacy
carded commercial chemical products) procedure.
• Characteristic wastes, which exhibit one or • Training must be provided for all employees.
more of four characteristics defined by ignit- Protected health information includes the following:
ability, corrosivity, reactivity, and toxicity • Any information related to past, present, or future
• Pharmacies arrange for the disposal of their haz- physical and mental health
ardous waste through an outside vendor that • Past, present, or future payments for health ser-
must adhere to the regulations contained in vices received
the RCRA. • Specific care the patient received, is receiving, or is
willing to receive
DIETARY SUPPLEMENT HEALTH • Any information that can identify the patient as
AND EDUCATION ACT OF 1994 the individual receiving the care such as patient
Herbal products are dietary supplements rather than name; Social Security number; date of birth, ad-
drugs. The manufacturers of supplements are al- mission, discharge, or death; telephone and fax
lowed to make claims with regard to general health numbers; e-mail addresses, medical records or
promotion but not disease claims. According to the account numbers, or health plan beneficiary num-
Dietary Supplement Health and Education Act bers; certificate or license numbers; photographs;
(DSHEA), herbal products must meet the following biometric indicators
requirements: Protected health information can only be released by
• Be labeled as a dietary supplement • Written consent of the patient
• Have labeling that identifies all ingredients by name • Subpoena
• Have labeling that lists the quantity of each • Mandatory reporting
ingredient Components of HIPAA:
• Have packaging that identifies the plant and plant • Title I: Insurance reform. Protects health insur-
part from which the ingredient is derived ance coverage for workers and families when they
• Comply with any standards set by an official change or lose their jobs
compendium • Title II: Administrative simplification. Establishes
• Meet the quality, purity, and compositional electronic transaction and Code Set Standards;
specification requires health information privacy
98 Mosby’s Review for the Pharmacy Technician Certification Examination

Backup and Archiving Procedures • Certification of medical offices and clinics as treat-
for Stored Data and Documentation ment centers. No Internet, phone, or mail order
Computer systems must be backed up at regularly prescriptions may be filled.
scheduled times (possibly daily) to prevent loss of • Thirty-day prescription allotments
data if the system goes down for any reason. • A requirement that female patients have monthly
pregnancy testing and receive a negative test
MEDICARE PRESCRIPTION DRUG result before a prescription is renewed
IMPROVEMENT AND • Appropriate blood testing during treatment and
MODERNIZATION ACT OF 2003 30 days after treatment
• Provides for a voluntary prescription drug benefit • Yearly evaluation of treatment centers to ensure
to Medicare beneficiaries compliance with program
• Adds preventive medical benefits to senior • Mandatory quarterly reporting of all adverse reac-
citizens tions and mandatory reporting within 15 days of
• Lowers the reimbursement rates for Medicare all patient deaths associated with the drug
payment for durable medical equipment.
• Created a national competitive bidding program ANABOLIC STEROID CONTROL ACT
for durable medical equipment in 2007 OF 2004
• Changed the way Medicare pays for outpatient On January 20, 2004, the Anabolic Steroid Control
Part B drugs Act amended the Controlled Substances Act and re-
• Allowed for a voluntary Medicare-approved dis- placed the existing definition of anabolic steroid with
count card program, begun in June 2004 a new definition. The new definition altered the basis
• Medicare Part D prescription plan allows benefi- for all future administrative scheduling actions relat-
ciaries to enroll in either regional- or national- ing to the control of anabolic steroids as Schedule III
based insurance plans medications by eliminating the requirement to prove
• Provided for Medication Therapy Management muscle growth. This act increased the number of ana-
(MTM) bolic steroids to 59 substances. This amendment
provided the requirements for handling substances
ISOTRETINOIN SAFETY AND RISK defined as anabolic steroids to include registration,
MANAGEMENT ACT OF 2004 security, labeling and packaging, inventory, record
Isotretinoin (Accutane) is a very powerful medica- maintenance, prescriptions, disposal, importation
tion used to treat acne. Unfortunately, the medication and exportation, and criminal liability.
has been found to cause severe birth defects; induce
spontaneous abortions; and produce adverse psychi- COMBAT METHAMPHETAMINE
atric effects, including depression, psychosis, suicidal EPIDEMIC ACT OF 2005
ideation, suicide attempts, and suicide. Components • Placed ephedrine, pseudoephedrine, and phenyl-
of this legislation include: propanolamine in the Controlled Substances Act
• Mandatory registry of all patients, practitioners, category “scheduled listed chemical products”
and pharmacists • Products containing ephedrine, pseudoephedrine,
• Education of all practitioners and pharmacists re- and phenylpropanolamine are subject to sales re-
garding the risks associated with the drug, includ- strictions, storage requirements, and record-keeping
ing birth defects and mental health risks requirements.
• A requirement that Accutane and its generic • The Act specifies a 3.6 g/day base product sales
form are prescribed only for severe recalcitrant limit, a 9 g/30-day base product purchase limit,
nodular acne, the medical condition for which a blister package requirement, and mail order
Accutane was approved, that is unresponsive restrictions.
to conventional therapy, including antibiotics. • Logbook (written or electronic) requirements have
Accutane and its generic are often prescribed for been implemented and require the following:
mild acne or without other medications being products by name, quantity sold, names and ad-
tried first. dresses of purchasers, and date and time of sales.
• Monthly education of patients, both male and
female, regarding the need to avoid pregnancy, as MEDICAID TAMPER-RESISTANT
well as completion of a survey to warn the patient PRESCRIPTION ACT
of the adverse side effects. Patient visits include • Applies to all handwritten prescriptions for cov-
one-on-one counseling, and patients or parents ered outpatient drugs; drugs that are transmitted
must sign an informed consent form. from the prescriber to the pharmacy verbally, by
Chapter 2 Pharmacy Law and Regulations 99

fax, or through e-prescribing are not affected by ers and pharmacies must be registered before they
this legislation. can treat patients with Clozaril. CARE is designed
• Enforced whenever Medicaid pays any portion of and developed to streamline this process.
the cost of a prescription Approved generic manufacturers of clozapine
A tamper-resistant prescription pad must include have established similar programs to comply with
all of the following three characteristics: the FDA mandate.
• One or more industry-recognized features designed
to prevent unauthorized copying of a completed or THALIDOMIDE
blank prescription form Thalidomide is indicated for multiple myeloma,
• One or more industry-recognized features de- and certain conditions must be adhered to by the
signed to prevent the erasure or modification of patient. Thalidomide must not be taken by women
information written on the prescription pad by the who are pregnant or who could become pregnant
prescriber while taking this medication. A single dose of tha-
• One or more industry-recognized features de- lidomide taken during pregnancy can cause severe
signed to prevent the use of counterfeit prescrip- birth defects (physical problems present in the baby
tion forms at birth) or death of the unborn baby. A program
If a pharmacy receives a prescription and there are called System for Thalidomide Education and
questions regarding whether the prescription meets Prescribing Safety (STEPS) has been approved by
the requirements of the act, the pharmacy staff may the FDA to make sure that pregnant women do not
contact the prescriber’s office for verification. The take thalidomide and that women do not become
pharmacy may accept a faxed prescription from the pregnant while taking thalidomide. All people who
physician’s office until it has obtained tamper-resistant are prescribed thalidomide, including men and
prescription pads. A pharmacy may fill the prescrip- women who cannot become pregnant, must be reg-
tion as an emergency prescription as long as the phar- istered with STEPS, have a thalidomide prescrip-
macy receives documentation from the prescriber’s tion from a doctor who is registered with STEPS,
office within 72 hours. A prescription may be trans- and have the prescription filled at a pharmacy that
ferred from the original pharmacy to another phar- is registered with STEPS in order to receive this
macy by fax or telephone. The second pharmacy does medication.
not need to have direct confirmation of the original Patients must see their doctors every month dur-
prescription from the physician. ing their treatment to talk about their condition and
any side effects they may be experiencing. During the
patient’s visit, the doctor may provide a prescription
RESTRICTED DRUG PROGRAMS for up to a 28-day supply of medication with no re-
fills. The patient must have this prescription filled
within 7 days. Blood should never be donated if a
The Clozaril National Registry (CNR) was developed patient is taking thalidomide.
in response to an FDA mandate to ensure the safety of If a woman is taking thalidomide and can become
patients treated with Clozaril, which has potentially pregnant, she will need to meet certain requirements
dangerous side effects, if not strictly monitored. The during her treatment. A woman will need to meet
program includes dedicated 800 numbers for internal these requirements even if she has a history of not
clients, consumers, and health care professionals to call being able to become pregnant. A woman may be
for information, education, and patient enrollment. excused from meeting these requirements only if
The Clozaril Administration Registry Enrollment she has not had a period for 24 months in a row or if
(CARE) is a secured Internet application that facili- she has had a hysterectomy.
tates the reporting of white blood cell (WBC) values A woman must use two acceptable forms of birth
and absolute neutrophil counts (ANCs) of patients control for 4 weeks before beginning to take thalido-
taking brand Clozaril (clozapine) to the CNR. CARE mide, during treatment, and for 4 weeks after treat-
is designed to safeguard patient information, protect ment. The patient’s doctor will inform her about
patients’ privacy, and assist physicians and pharma- which forms of birth control are acceptable. A woman
cists with effective monitoring functionalities. will use these two forms of birth control at all times
Clozaril has only been available through a strict unless she can guarantee that she will not have any
monitoring and distribution system to detect the early sexual contact with a man for 4 weeks before, during,
onset of agranulocytosis. With proper WBC and ANC and for 4 weeks after treatment.
monitoring and reporting, Clozaril-induced agranu- A woman must have a negative pregnancy test
locytosis can be reversible if detected early. Prescrib- result within the 24 hours before beginning treatment
100 Mosby’s Review for the Pharmacy Technician Certification Examination

with thalidomide. In addition, she will also need to • Transferring a prescription can only occur be-
be tested for pregnancy in a laboratory weekly dur- tween two licensed pharmacies, and the pharmacy
ing the first 4 weeks of their treatment and then once possessing the original prescription must record
every 4 weeks if she has regular menstrual cycles or the following information in the patient profile:
once every 2 weeks if she has irregular menstrual date of the prescription transfer; the name, tele-
cycles. phone number, and address of the pharmacy re-
A woman should stop taking thalidomide and ceiving the transferred prescription; the name of
contact her physician immediately if she thinks she the pharmacist receiving the transferred prescrip-
is pregnant; has a late, irregular, or missed menstrual tion; and the number of refills remaining. “Void”
period; experiences any change in menstrual bleed- must be written on the original hard copy of the
ing; or has sex without using two forms of birth prescription.
control. If a woman becomes pregnant during treat- • The receiving pharmacy must indicate “Transfer”
ment, the physician is required to call the FDA and on the front of the prescription; the date it was re-
the manufacturer. ceived from the other pharmacy; the name of the
If a man is prescribed thalidomide, he must be pharmacist; the name, address, and telephone of the
aware that thalidomide is present in his semen pharmacy; the original date of the original prescrip-
and must either use a latex condom or completely tion; and the number of refills remaining.
avoid any sexual contact with a woman who is • A pharmacy technician may fax a copy of a pre-
pregnant or may become pregnant while taking scription to another pharmacy under the supervi-
this medication and for 4 weeks after treatment. sion of a pharmacist.
Although a man may have had a vasectomy, this is
still required. The man must notify his physician
immediately if he has had unprotected sex with a
woman who can become pregnant or if he thinks • Biennial inventory of narcotics: Must be main-
for any reason that his partner is pregnant. A man tained in the pharmacy
should not donate semen or sperm while taking • Change of pharmacist-in-charge inventory: Must
thalidomide. be maintained in the pharmacy
• Controlled substance invoices: Must be main-
tained in the pharmacy. Schedule II invoices
GENERIC SUBSTITUTION should be attached to pharmacy’s copy of the DEA
Generic substitution laws are state specific. In most Form 222 with the appropriate dating and signa-
states, pharmacists and pharmacy technicians cannot ture. Schedule III to V invoices need to be stamped
substitute nontherapeutic equivalent products. Some with a red C, dated, and signed by the individual
states allow substitution between products as long as checking the invoice. Schedule III to V invoices
state-specific criteria are met, such as having the need to be kept separate from Schedule II invoices.
same active ingredient, dosage form, dose, and route • Exempt narcotic log: Requires the name and ad-
of administration. States may require that a generic dress of purchaser (must be at least 18 years of age),
drug will be dispensed unless the prescriber indi- name of product and date sold, seller’s signature,
cates otherwise through a specific designation such and price of the product. The pharmacist must
as “Brand Name Medically Necessary,” “Dispense as be present for any transaction involving “exempt
Written,” or “DAW” in the prescriber’s own hand- narcotics.”
writing. Both pharmacists and pharmacy technicians • Master formula record: Work sheets are consid-
must be familiar with their own state’s regulations ered permanent records. Provides directions for
regarding generic substitution. compounding and uniform record keeping. Quan-
tities and lot numbers of ingredients used; initials
of the preparer and pharmacist who checked the
STATE-SPECIFIC PRESCRIPTION work; and calculations performed to determine
TRANSFER REGULATIONS how long the compound must be kept.
Technicians must be familiar with their state laws • Safety Data Sheets (SDSs): Documentation re-
regarding the transfer of prescriptions between phar- quired by OSHA; a facility must receive this sheet
macies. Federal law states that controlled substance time every time a hazardous chemical is provided to
prescriptions can be transferred only one time it. Hazardous chemicals may be either physical or
between pharmacies. Pharmacy technicians may as- health hazards.
sist the pharmacist in the transfer of prescriptions • Medication administration record (MAR): Pro-
between pharmacies. vides documentation that a drug has actually been
Chapter 2 Pharmacy Law and Regulations 101

dispensed in a hospital or long-term facility. MARs • Ingredient selection

are found in hospitals and long-term care facilities. • Compounding nondrug requirements
• Nonsterile compounded products: All recipe in- • Criteria for compounding capsules, powders, loz-
formation is copied and shows the step-by-step enges, tablets, emulsions, solutions, suspensions,
process. The following information is documented: suppositories, cream, topical gels, ointments, and
date prepared, name of ingredients, manufactur- pastes
ers of ingredients, lot number and expiration date • Compounding process
of each ingredient, amount or weight of each in- • Compounding records and documents to include
gredient, dosage form of each ingredient, phar- formulation record, compounding record, and
macy lot number assigned, technician’s initials, SDS file
pharmacist’s initials, date dispensed, patient’s • Quality control
name, and medical record number. This informa- • Verification
tion must be maintained for a minimum of 2 years. • Patient counseling
• Poison log: Requires name and address of pur- Balances must be certified yearly by the state depart-
chaser (must be at least 18 years of age), name of ment of taxation.
product and date sold, intended use, seller’s sig-
nature, and price of product UNITED STATES PHARMACOPEIA
• Prescription hard copy: On the back of the hard copy ,797.
of the prescription is a copy label with the initials of United States Pharmacopeia ,797. is designed to
the pharmacist or technician who filled the prescrip- cut down on infections transmitted to patients
tion. Prescriptions are filed numerically. Electronic through pharmaceutical products and to better pro-
backup copies are made at the end of the day. They tect staff working in pharmacies in the course of their
must be maintained for a minimum of 2 years. exposure to pharmaceuticals. USP ,797. contains
• Repackaged medications: All repackaged medica- many procedural training and quality assurance
tions must be maintained on a log with the follow- requirements for preparing sterile products. USP
ing information: date, drug, dosage form, manufac- ,797. affects all health care institutions, pharma-
turer, manufacturer’s lot number, manufacturer’s cies, physicians’ practices, and other facilities in
expiration date, pharmacy lot number, pharmacy which compounded sterile preparations are pre-
expiration date, technician, and pharmacist. The in- pared, stored, and dispensed.
formation must be readily retrievable. Facilities affected by USP ,797. include facilities
where sterile products are prepared according to
manufacturer’s labeling and where manipulations
PHARMACY STANDARDS are performed during the compounding of sterile
products that increase the potential for microbial
contamination of the end product. It affects facilities
where products are compounded using devices or
United States Pharmacopeia (USP) ,795. provides ingredients that are not sterile to prepare compounds
guidance on applying good compounding practices in that must be sterilized. These products may be bio-
the preparation of nonsterile compounded formula- logics, diagnostic agents, drugs, nutrients, or radio-
tions for dispensing or administration to humans or pharmaceuticals that include but are not limited to
animals. USP ,795. was recently revised, and the baths and soaks for live organs and tissues, implants,
chapter now includes new material; such as categories inhalations, injections, irrigations, metered sprays,
of compounding (simple, moderate, and complex), and ophthalmic and otic preparations.
new definitions for terms (e.g., beyond-use date, haz- United States Pharmacopeia ,797. addresses the
ardous drug, stability), and criteria for compounding following areas:
each drug preparation (e.g., suitable compounding • Microbial contamination risk levels, which are de-
environment, use of appropriate equipment). fined as low-, medium-, and high-risk conditions
Areas addressed under USP ,795. include: • Personnel training and evaluation in aseptic ma-
• The facility nipulation skills
• Equipment • Clean rooms to include anterooms, air classifica-
• Stability of the compounded preparation tion, physical characteristics of the construction,
• Primary packaging and gowning procedures
• Sterility • Barrier isolators
• Stability criteria to include beyond-use dating • Formalized quality assurance program
• Beyond-use labeling • Minimum requirements for validation
102 Mosby’s Review for the Pharmacy Technician Certification Examination

• Cleaning and sanitizing workspaces SANITATION REQUIREMENTS

• Environmental monitoring All pharmacies are required to have potable water for
• Verification of automated compounding devices hand and equipment washing; Purified water must
for nutrition compounding be available for nonsterile compounding; water for
injection or sterile water for injection or bacteriostatic
Hand Washing water for injection is required for sterile compound-
• No jewelry should be worn in the hood. This in- ing. A pharmacy is required to be clean and in a
cludes artificial nails because of microbial growth sanitary condition with adequate washing facilities
around or underneath. to include hot and cold water, soap or detergent, and
• Long hair should be tied back away from the face. air driers or single-service towels. Sewage, trash, and
• Hands must be washed after entering the IV area other refuse is to be disposed of in a safe, sanitary,
and before entering the laminar flow hood. and timely manner. Equipment is to be thoroughly
• Hands, wrists, and arms to the elbow should be cleaned promptly to avoid cross-contamination of
washed with antimicrobial soap and hot water for ingredients and preparations. Special precautions are
at least 30 seconds and no more than 90 seconds. to be taken to clean equipment and compounding
areas that contain allergenic ingredients, such as sul-
Laminar Flow Hood Maintenance fonamides or penicillins.
• The blower of the laminar airflow hood should be SANITATION DOCUMENTATION
kept on at all times. If it is shut down, then it must A pharmacy should have a written and implemented
be in operation for at least 30 minutes before use. plan that documents periodic environmental moni-
• The hood is wiped down with 70% isopropyl alco- toring, employee monitoring, and end product evalu-
hol beginning with the bar followed by the sides ation testing that complies with state BOP regulations
and continuing from the area closest to the filter, and USP ,795. and USP ,797. requirements.
working outward and wiping from the top edge of
the side to the bottom.
• The bench is cleaned last by beginning from the
back of the bench and wiping from side to side
and moving outward. A hazardous drug is one that exhibits one or more of
• The laminar flow hood should be cleaned at the the following effects in humans or animals: carcino-
beginning of every shift and whenever a spill oc- genicity, teratogenicity, reproductive toxicity, organ
curs. Sanitizing agents should not be sprayed toxicity, and genotoxicity.
because the HEPA filter may become damp and • Hazardous material is one that may produce an ad-
develop a hole. verse effect on a human being or the environment.
• The flow hood needs to be certified every 6 months • Infectious waste includes blood, blood products
or whenever the HEPA filter becomes wet. and body fluids, infectious sharps waste, labora-
tory waste, and animal waste.
Laminar Hoods and HEPA Filters • OSHA requires that employees be protected from
These need to be certified a minimum of every hazardous drugs and chemicals by using personal
6 months or when the HEPA filter is wetted or the protective equipment that includes laboratory
laminar flow hood is moved. Validation is docu- coats, gloves, masks, and goggles.
mented evidence that provides a high degree of as- • Hands should be washed before and after donning
surance that the process will produce a product with gloves.
predetermined specifications. • Nonpowdered gloves should be worn when han-
dling hazardous drugs or waste.
INFECTION CONTROL STANDARDS • Hypoallergenic gloves should be available to em-
Universal precautions have established and imple- ployees who are allergic to latex.
mented in the practice of pharmacy to reduce the • Double gloving is required where the first pair of
likelihood of transmitting harmful pathogens. These gloves is under the sleeve of the laboratory coat
precautions include: and the second pair of gloves covers the sleeve of
• Wash hands before and after each medical proce- the laboratory coat.
dure (may use a waterless hand cleaner). • Gloves should be changed hourly or after con-
• Wear gloves whenever there is a possibility of tamination.
coming in contact with blood or other potentially • Gloves should be removed to avoid direct skin
infectious materials (body fluids and tissues). contact.
Chapter 2 Pharmacy Law and Regulations 103

• Face and eye protection should be used whenever her from possible contamination. A 4- 3 4-inch
splashes, sprays, or aerosols of hazardous drugs piece of gauze should be kept inside the hood in
could result in eye, nose, or mouth contamination. case of a spill. A preparer should know the loca-
• Spill kits must be available in areas where hazard- tion of the cleanup kit. Refer to OSHA guidelines
ous drugs are being prepared. regarding the storage and handling of chemo-
• OSHA requires that bags containing materials con- therapeutic agents.
taminated with hazardous drugs should be labeled • Hazardous substances include syringes, needles,
“Hazardous Drug Waste.” and toxic medications. Used needles and syringes
• “Hazardous Drug Waste” bags must be thick, should be placed in a red plastic sharps container
leakproof, and of a different color than other to be autoclaved and disposed of. Toxic substances
trash bags. (e.g., chemotherapeutic agents) should be placed in
• Hazardous drug waste bags should be kept in a cov- a red biohazard bag to be picked up by the appro-
ered waste container that identifies it as “Hazardous priate authorities for destruction. Refer to OSHA
Drug Waste.” guidelines regarding the storage and handling of
• A hazardous drug waste container should be in hazardous substances.
each area where hazardous drugs are prepared
and administered. NATIONAL REGULATORY
• Bag should be sealed when filled, and the covered COMMISSION REGULATIONS AND
waste container should be tightly taped. STANDARDS
• Sharps containers should be used for disposing Nuclear pharmacy is a specialized pharmaceutical
used needles and breakable items such as am- care service that has been defined as a patient-
pules, single, and multidose vials. oriented service that embodies the scientific knowl-
• Hazardous drug waste should be stored in a se- edge and professional judgment required to improve
cure area until it is disposed of according to EPA and promote health through assurance of the safe and
regulations for hazardous waste. efficacious use of radioactive drugs for diagnosis and
PROCEDURES FOR THE TREATMENT A nuclear pharmacy has designated rooms to per-
OF EXPOSURE TO HAZARDOUS form the following specific functions:
SUBSTANCES • Breakdown room: Area where empty or used ra-
• Chemotherapy spill kits should be used for the diopharmaceuticals are returned and dismantled
cleanup of accidental spills of antineoplastic for reuse
agents. These kits include waste disposal bags, a • Order entry area: Area where prescription orders
respirator, latex gloves, heavy utility gloves, eye- for radiopharmaceuticals are entered
glasses, gowns, shoe covers, toweling, and seal- • Compounding area: Compounding or dispens­
able bags. ing area
• The technician should know the location of the • Quality-control area: Quality assurance tests are
SDSs and should follow the directions on them performed before delivery.
for a particular item. After completion of the • Packaging area: Finished product is packaged for
cleanup, an incident report should be filed with delivery.
the supervisor. • Storage and disposal area: Storage area for radio-
• If a hazardous substance comes in contact with the active waste
skin, it must be washed immediately with soap • Requires special equipment: Fume box, glove box,
and water for at least 5 minutes. If a substance dose calibrator, Geiger-Müller counter, dosimeter,
comes in contact with the eyes, they should be lead-lined refrigerator and freezer, lead-lined stor-
rinsed for 15 minutes. This can be done at the eye- age boxes, autoclave, heating equipment, testing
wash station. equipment, centrifuge, lead barrier shield, stainless
steel sink, shower, and respirator
STORAGE AND HANDLING Standards have been established in the following
SUBSTANCES • Procurement
• Chemotherapeutic agents and cytotoxic materials • Compounding
must be prepared in a biologic safety cabinet or • Quality assurance
vertical flow hood and placed in bags identifying • Dispensing
them as such. The preparer should wear a gown, • Distribution
goggles, and two pairs of gloves to protect him or • Health and safety
104 Mosby’s Review for the Pharmacy Technician Certification Examination

• Provision of information and consultation EQUIPMENT

• Monitoring patient outcome Equipment is to be of appropriate design and size
• Research and development for compounding and suitable for the intended pur-
The Nuclear Regulatory Commission (NRC) con- poses. The types and sizes of equipment depend on
trols the use and disposal of radioactive materials the dosage forms and quantities compounded. Pre-
and the safety of the employees and the public. Any scription balances may be class A, micro-, semimicro-,
pharmacy that deals with radioactive compounds or single-pan balances. Pharmacy weights include
must possess the following: both metric and apothecary weights. Other pharmacy
• A license from the NRC equipment includes graduated cylinders for reconsti-
• A traditional pharmacy license issued by the tution, various mortars and pestles for mixing, spatu-
state BOP las, and stirring rods. Laminar airflow hoods are
• A nuclear pharmacist in charge required for preparing IV preparations and chemo-
• A list of personnel who have met specialized re- therapy agents.
quirements for training and experience to handle
radioactive materials DRUG STORAGE
• Detailed floor plans that have been approved by All Schedule II forms must be stored in a locked safe
the NRC (either combination or key lock). Schedule III to V
• A separate area for radiation storage and decay medications may be dispersed throughout the phar-
• Maintenance of strict records for the receipt, storage, macy with the other medications. Refrigerated medi-
compounding, disposal, and transport for radioac- cation must be stored in a refrigerator.
tive material
• Compounding records PRESCRIPTION STORAGE
• Radiopharmaceutical unit-dose dispensing Prescriptions, biennial inventories, invoices, and
• Regularly monitored for external radiation expo- Forms 222 and 41 must be readily retrievable (able
sure and contamination to be produced within 72 hours of the request).
• Compounding areas surveyed daily Prescriptions may be filed either by separating
• Storage areas surveyed weekly the Schedule II, Schedule III to V, and noncontrolled
• Exposure limits for personnel prescriptions or by filing the Schedule II to V pre-
• Radiopharmaceutical labeling scriptions separately from prescriptions for non-
• Posting of radiation caution signs scheduled drugs.
• Radioactive spills
• Radiopharmaceutical errors


REQUIREMENTS Required resources include the Federal Controlled
Substances Act, USP and National Formulary, and
other texts (statutes) required by the state BOP.
State BOPs require a minimum amount of counter Examples of reference books that may be found in a
space in a pharmacy, an alarm system to be activated pharmacy library include the following:
when the pharmacy is not open, separate refrigerators • American Drug Index, St. Louis: Facts and Com-
for refrigerated medications and controlled substances parisons. This standard reference work contains
(must be lockable), a safe for Schedule II medications, more than 20,000 entries on drugs and drug prod-
and a sink with hot and cold water. Areas designated ucts, including alphabetically listed drug names,
for compounding have adequate space for the orderly cross-indexing, phonetic pronunciations, brand
placement of equipment and materials to prevent mix- names, manufacturers, generic or chemical names,
ups between ingredients, labels, in-process materials, composition and strength, pharmaceutical forms
and finished materials. The compounding area is de- available, package size, use, and common abbre-
signed, arranged, used, and maintained to prevent viations. It also contains a listing of orphan drugs.
cross-contamination. Areas used for sterile prepara- The work is available in hardbound and CD-ROM
tion are to be separated and distinct from nonsterile editions. www.­factsandcomparisons.com
compounding. The area is to be well lighted. Heating, • American Hospital Formulary Service Drug Information,
ventilation, and air conditioning systems must be con- Bethesda, MD: American Society of Health-System
trolled to avoid decomposition. The pharmacy must Pharmacists. The complete text of roughly 1400
be kept clean and uncluttered. monographs covering about 50,000 commercially
Chapter 2 Pharmacy Law and Regulations 105

available and experimental drugs, including infor- • Index Nominum, Geneva: Swiss Pharmaceutical So-
mation on uses, interactions, pharmacokinetics, dos- ciety. A compilation of synonyms, formulas, and
age, and administration. www.ashp.org therapeutic classes of more than 7000 drugs and
• Ansel HC, Allen LV, Popovich NG. Pharmaceutical 28,000 proprietary preparations from 27 countries.
Dosage Forms and Drug Delivery Systems, Baltimore: Available in text and CD-ROM formats.
Williams & Wilkins. A superb survey of contempo- • The International Pharmacopeia, New York: World
rary dosage forms and delivery systems. www. Health Organization. Recommended production
lww.com methods and specifications for drugs, in four vol-
• Drug Facts and Comparisons, St. Louis: Facts and umes. www.who.ch
Comparisons. This comprehensive source of infor- • Koda-Kimble M, Young LY. Applied Therapeutics:
mation about 16,000 prescription and 6000 OTC The Clinical Use of Drugs. Vancouver, WA: Applied
drugs contains monographs about individual Therapeutics.
drugs and groups of related drugs; product list- • Patient Drug Facts: Professionals Guide to Patient Drug
ings in table format providing information on dos- Facts, St. Louis: Facts and Comparisons. Compre-
age forms and strength, distributor names, costs, hensive guide to patient counseling about drugs,
package sizes, product identification codes, flavors, available in loose-leaf format for verbal patient
colors, and distribution status; and information on counseling and in PC format (on disk) for creation of
therapeutic uses, interactions, and adverse reac- patient handouts. www. factsandcomparisons.com
tions. The publication includes an index of manu- • Physicians’ Desk Reference. Oradell, NJ: Medical
facturers and distributors and controlled substance Economics. Available in hardbound and CD-ROM
regulations. This reference work is available in form with two supplements published twice a
hardbound form, on CD-ROM, or in a loose-leaf year, this standard reference work contains infor-
form that is updated monthly. www.factsandcom- mation from package inserts for more than 4000
parisons.com prescription drugs, as well as information on 250
• Drug Information Fulltext, Norwood, MA: Silver- drug manufacturers. www.medec.com
platter. A searchable computer database combin- • Stringer JL. Basic Concepts in Pharmacology: A
ing two publications, the American Hospital For- Student’s Survival Guide. New York: McGraw-Hill.
mulary Service Drug Information and the Handbook Survey of basic pharmacologic concepts for students.
on Injectable Drugs. This database is available on www.pbg.mcgraw-hill.com
hard disk, on CD-ROM, or the Internet. www. • USP and the National Formulary, Rockville, MD,
silverplatter.com United States Pharmacopeial Convention. Combined
• Drug Interaction Facts, St. Louis: Facts and Com- compendium of monographs setting official national
parisons. This reference, available as a hardbound standards for drug substances and dosage forms
book, CD-ROM, or loose-leaf book that is updated (USP) and standards for pharmaceutical ingredients
quarterly, provides comprehensive information on (National Formulary). Available in book or CD-ROM
potential interactions that can be reviewed by form and in English- and Spanish-language editions.
drug class, generic drug name, or trade name. Pro- www.usp.org
vides information on drug–drug and drug–food • USP Dictionary of USAN and International Drug
interactions. www.factsandcomparisons.com Names, Rockville: MD, United States Pharmaco-
• FDA: Approved Drug Products with Therapeutic peial Convention. An authoritative guide to drug
Equiv­alence Evaluations, Washington, DC: U.S. names, including chemical names, brand names,
Government Printing Office. Revised annually, manufacturers, molecular formulas, therapeutic
with monthly updates, this source lists drug prod- uses, and chemical structures. www.usp.org
ucts approved for use in the United States. Also • Benitz WE, Tatro DS. The Pediatric Drug Handbook.
known as the Orange Book because of its orange- St. Louis: Mosby. Information on drugs, dosage
colored cover, it is available online at www.fda. forms, and administration for pediatric patients.
gov/cder/ob/default.htm. www.mosby.com
• Goodman and Gilman‘s the Pharmacological Basis of • Davies DM. Textbook of Adverse Drug Reactions,
Therapeutics, New York: McGraw-Hill. An authori- New York: Oxford University Press. A standard
tative text on pharmacology and therapeutics con- textbook on the subject. www.oup-usa.org
taining 67 articles by leading experts in the field. • Goldfrank’s Toxicologic Emergencies, New York:
This text provides information for pharmacists to Appleton & Lange. Information on treating toxico-
help them answer clinical questions about how logic emergencies. The medical titles of Appleton &
drugs work under different conditions in the body. Lange are distributed by McGraw-Hill and may be
www.pbg.mcgraw-hill.com found at that website. www.pbg.mcgraw-­hill.com
106 Mosby’s Review for the Pharmacy Technician Certification Examination

• Handbook of Nonprescription Drugs, Washington, • OSHA.gov

DC: American Pharmaceutical Association. A refer- • USP.org
ence work on OTC medications. www.aphanet.org • ISMP.org
• Hunt ML Jr. Training Manual for Intravenous Admix- • Pharmacist.com
ture Personnel. Chicago: Bonus Books. A manual • ASHP.org
for training people to create parenteral prepara- • Facts and Comparisons.com
tions. www.bonus-books.com • PDR.net
• The King Guide to Parenteral Admixtures, Napa, CA:
King Guide Publications. Available in four loose- PHARMACY JOURNALS OF SPECIFIC
leaf volumes, on microfiche, and on CD-ROM, the PHARMACY ORGANIZATIONS
King Guide provides 350 monographs on compati- • AACP: American Journal of Pharmaceutical Education
bility and stability information critical to deter- • AAPS: Pharmaceutical Research
mining the advisability of preparing admixtures of • AMCP: Journal of Managed Care Pharmacy
drugs for parenteral administration. The guide is • AJHP: American Journal of Health System Pharmacists
updated quarterly. www.kingguide.com • APhA: Journal of American Pharmacists Association;
• Nahata MC, Hipple TF. Pediatric Drug Formula- Pharmacy Today
tions. Cincinnati: Harvey Whitney. Information on • ASCP: The Consultant Pharmacist
formulation and compounding of drugs for pedi- • CRS: Journal of Controlled Release
atric patients. hwb@eos.net • ISMP: ISMP Medication Safety Alerts Newsletter
• Poisindex System, Englewood, CO: Micromedex. A • NCPA: America’s Pharmacist
computerized poison information system. www. • NPTA: Today’s Technician
• Remington The Science and Practice of Pharmacology. PHARMACY MAGAZINES
Philadelphia: Lippincott. The compounding “bi- • Chain Drug Store News
ble” of the pharmacy profession. • Drug Topics
• Stoklosa MJ, Ansel HC. Pharmaceutical Calcula- • Hospital Pharmacy
tions, Baltimore: Williams & Wilkins. A clear, con- • Journal of Managed Care Pharmacy
cise, thorough introduction to pharmaceutical • Pharmacy Times
mathematics. www.lww.com • The Script
• Trissel LA. Handbook on Injectable Drugs, with Supple- • U.S. Pharmacist
ment. Bethesda, MD: American Society of Health-
System Pharmacists. Provides information on sta-
bility and compatibility of injectable drug products, REGULATORY AGENCIES
including formulations, concentrations, and pH
values. www.ashp.org
• Understanding and Preventing Errors in Medication
Orders and Prescription Writing, Bethesda, MD: • Oversees Medicare and Medicaid
United States Pharmacopeial Convention. An edu- • Establishes conditions for a facility to be reim-
cation resource consisting of lecture materials, bursed for services rendered
videotapes, and 35-mm slides describing medica-
tion errors that arise from poorly written orders DEPARTMENT OF TRANSPORTATION
and prescriptions, using examples of actual re- • Regulates the shipment of hazardous materials
ports received through the USP Medication Errors that includes radioactive materials
Reporting Program. Contains recommendations • Controls the packaging, labeling, and transporta-
for preventing errors. www.usp.org (search within tion of radioactive materials
USP Educational Programs)
ELECTRONIC PHARMACY • Enforces compliance with the Controlled Sub-
REFERENCES stances Act
• DEA.gov • Places medications into the appropriate schedule
• FDA.gov • Monitors records and reports of controlled sub-
• Drug Recalls stances
• Orange Book-Approved Drug Products with • Registers pharmacies
Therapeutic Equivalence • Issues DEA Forms 222 and 41
• MEDWATCH • Monitors the destruction of controlled substances
Chapter 2 Pharmacy Law and Regulations 107

ENVIRONMENTAL PROTECTION chemical dependency centers, health care net-

AGENCY works, and preferred provider organizations
• Sets guidelines for the disposal of hazardous • TJC has been granted “deemed status” for par-
waste (includes disposal of controlled substances) ticipation in Medicare. This status states that
the institution has met the Medicare Conditions
FOOD AND DRUG ADMINISTRATION of Participation and can receive Medicare fund-
• Ensures that all pharmaceutical products are pure, ing. The institution does not need to meet re-
safe, and effective quirements for annual Medicare surveys by state
• Reviews information supplied on MedWatch Forms inspectors.
• Issues drug recalls if product is adulterated or
misbranded and has not been removed by the NATIONAL ASSOCIATION
drug manufacturer OF THE BOARDS OF PHARMACY
• Class I recall: A situation in which there is a • Composed of all state Boards of Pharmacy (BOPs)
reasonable probability that the use of or expo- • No regulatory authority but meets to discuss
sure to a violative product will cause serious current trends and issues in pharmacy that affect
adverse health consequences or death the practice of pharmacy
• Class II recall: A situation in which use of or
exposure to a violative product may cause tem- STATE BOARDS OF PHARMACY
porary or medically reversible adverse health • Regulatory state agency that oversees the practice
consequences or in which the probability of of pharmacy in a given state
serious adverse health consequences is remote • Define regulations affecting pharmacy and the
• Class III recall: A situation in which use of or roles, duties, and expectations of pharmacists and
exposure to a violative product is not likely to pharmacy technicians in that state
cause adverse health consequences • Establish criteria for continuing education for both
The FDA performs postrecall audits to verify that pharmacists and pharmacy technicians to remain
manufacturers, wholesalers, pharmacists, and cus- credentialed for their profession
tomers have been notified and appropriate action has • Have the authority to discipline pharmacies, phar-
occurred. macists, and possibly pharmacy technicians for
• Regulates the distribution of patient package inserts improper behavior
and the repackaging of medications
• Reviews new drug applications and investiga- UNITED STATES PHARMACOPEIA
tional new drug applications • The USP is an official public standards-setting
• Establishes “Medicine Take Back Programs” in authority for all prescription and OTC medicines
communities and other health care products manufactured or
sold in the United States.
INSTITUTIONAL REVIEW BOARD • Establishes standards for food ingredients and
• A board, committee, or other group designated by dietary supplements
an institution to approve biomedical research in • Creates standards for the quality, purity, strength,
accordance with the FDA and consistency of these products; critical to public
health. USP’s standards are recognized and used in
THE JOINT COMMISSION more than 130 countries around the globe.
• The Joint Commission (TJC), formerly known as
the Joint Commission on Accreditation of Health-
care Organizations (JCAHO), addresses quality of
patient care and patient safety
• Establishes standards and accredits the following • Performance appraisal: A process of systematically
health care providers: hospitals, home health care evaluating performance and providing feedback on
agencies, home infusion providers, long-term which performance adjustments can be made. Per-
care pharmacies, ambulatory infusion pharma- formance appraisals define specific job criteria
cies, home medical equipment and home oxygen against which performance will be measured, mea-
providers, ambulatory surgical centers, commu- sure past job performance accurately, justify re-
nity health centers, college and prison health care wards given to individuals and groups, and define
centers, nursing homes and subacute facilities, the developmental experiences employees need
assisted living facilities, clinical laboratories, to enhance their performance in the current job and
behavioral health organizations, alcohol and to prepare for future responsibilities.
108 Mosby’s Review for the Pharmacy Technician Certification Examination

• Activity measures: A rating system based on an 2. A pharmacist fails to place a prescription label on the
evaluator’s observation and rating medication container. Which law is being broken?
• Ranking: A comparative technique of perfor- a. Pure Food and Drug Act of 1906
mance appraisal that involves rank ordering of b. Food, Drug, and Cosmetic Act of 1938
each individual from best to worst on each perfor- c. Durham-Humphrey Act of 1950
mance dimension d. Kefauver-Harris Act of 1962
• Paired comparison: A comparative method of per-
formance appraisal whereby each person is directly 3. An employee injures his back while lifting a carton
compared with every other person of medication in the pharmacy. What law allows the
• Forced distribution: A method of performance ap- employee to collect damages from the employer?
praisal that uses a small number of performance a. Kefauver-Harris Act of 1962
categories, such as “very good,” “good,” “adequate,” b. Occupational Safety and Health Act of 1970
and “very poor,” and forces a certain proportion of c. Omnibus Budget Reconciliation Act of 1987
people into each d. Poison Prevention Act of 1970
• Graphic rating scales: A scale that lists a variety of
dimensions thought to be related to high perfor- 4. A patient requests that the pharmacist place his
mance outcomes in a given job and that the indi- medication in an easy-open container. Which law
vidual is expected to exhibit allows the pharmacist to dispense the prescription
• Critical incident diary: A method of performance in this manner?
appraisal that records incidents of unusual success a. Kefauver-Harris Act of 1962
or failure in a given performance aspect b. Controlled Substances Act of 1970
• Behaviorally anchored rating scales: A perfor- c. Occupational Safety and Health Act of 1970
mance appraisal approach that describes observable d. Poison Prevention Act of 1970
job behaviors, each of which is evaluated to deter-
mine good versus bad performance 5. A pharmacist prepares a prescription with a mor-
• Management by objective: A process of joint goal tar and pestle that have been contaminated by an
setting between a supervisor and a subordinate antineoplastic agent and dispenses the prescrip-
• 360 evaluations: A comprehensive approach that tion to a patient. Which law is he violating?
uses self-ratings, customer ratings, and others out- a. Pure Food and Drug Act of 1906
side the workforce b. Food, Drug, and Cosmetic Act of 1938
c. Durham-Humphrey Act of 1950
EMPLOYEE PERFORMANCE d. Kefauver-Harris Act of 1962
Feedback is the process through which the receiver 6. Which law allows a pharmacist to accept a tele-
communicates with the sender by returning another phoned prescription from a physician’s office?
message. Suggestions for giving constructive feed- a. Pure Food and Drug Act of 1906
back include the following: b. Food, Drug, and Cosmetic Act of 1938
• Give feedback directly and in a spirit of mutual c. Durham-Humphrey Act of 1950
trust. d. Kefauver-Harris Act of 1962
• Be specific.
• Give feedback when receiver is most ready to 7. Which law allows a pharmacist to dispense nitro-
accept it. glycerin tablets in a non–child-resistant container?
• Be accurate; check validity with others. a. Durham-Humphrey Act of 1950
• Focus on things the receiver can control. b. Kefauver-Harris Act of 1962
• Limit how much the receiver gets at one time. c. Controlled Substances Act
d. Poison Control Act
8. Which law resulted in clearly distinguishing an
1. What do the middle four numbers represent in an over-the-counter medication from a prescription
NDC number? medication?
a. Drug manufacturer a. Pure Food and Drug Act of 1906
b. Drug product b. Food, Drug, and Cosmetic Act of 1938
c. Drug packaging c. Durham-Humphrey Act of 1950
d. None of the above d. Kefauver-Harris Act of 1962
Chapter 2 Pharmacy Law and Regulations 109

9. Which law required that the federal legend 14. Which of the following is a correct DEA number
appear on all prescriptions? for a Dr. Andrea J. Shedlock, who was Dr. Andrea
a. Pure Food and Drug Act of 1906 Costello when she requested her DEA number
b. Food, Drug, and Cosmetic Act of 1938 before she was married?
c. Durham-Humphrey Act of 1950 a. AC1234563
d. Kefauver-Harris Act of 1962 b. AS1234563
c. JC1234563
10. For how long is a DEA Form 222 valid? d. JS1234563
a. 1 week
b. 1 month 15. You are working for a chain pharmacy, and an-
c. 60 days other member of the chain has run out of DEA
d. 6 months Form 222s. They ask to borrow one of your DEA
Form 222s. What would you do?
11. Which law requires that a manufacturer provide a. Because you are members of the same phar-
Safety Data Sheets (SDS—formerly known as macy chain, you are allowed to let them use
MSDS) to a pharmacy for products that are com- yours because you have the same DEA number.
bustible, are flammable or can cause injury to an b. Give them one of your DEA Form 222s with
individual if he or she comes in contact with the the agreement that they will replace it after
substance? they receive their new ones.
a. Kefauver-Harris Act of 1962 c. DEA Form 222s are for a specific pharmacy
b. Controlled Substances Act of 1970 and can be used only by the pharmacy to
c. Occupational Safety and Health Act of 1970 which they were issued.
d. Poison Prevention Act of 1970 d. Tell them to place an emergency order with
the wholesaler and that you will provide them
12. A pharmacist receives a prescription for 40 Perco- with a properly completed DEA Form 222 in
cet tablets, but the pharmacy has only 15 tablets 72 hours.
in stock. The patient accepts the 15 tablets. How
much time does the pharmacist have to provide 16. You receive a request from another pharmacy for
the remaining 25 tablets? 100 Percocet tablets. What do you do?
a. 24 hours a. You may loan them the requested 100 tablets
b. 72 hours of Percocet.
c. 96 hours b. You may sell them the 100 tablets of Percocet
d. 6 months at the AWP.
c. You may transfer to them the 100 tablets of
13. If a patient requests a partial filling of her Tylenol Percocet through the use of a DEA Form 222.
with codeine #3 prescription, what can the phar- d. None of the above can be done.
macist do for the patient?
a. The pharmacist may provide the patient with 17. What form is used to report the theft of con-
the requested amount and places the remain- trolled substances?
ing tablets in a bottle for the patient to pick up a. DEA Form 41
at a later date. b. DEA Form 106
b. The pharmacist may provide the patient with c. DEA Form 222
the requested amount and informs her that d. DEA Form 224
she must pick up the remaining quantity
within 72 hours. 18. Which of the following is part of HIPAA?
c. The pharmacist may provide the patient with a. Allows a member of a plan to select any phar-
the requested amount and informs her that macy for his or her pharmacy benefit as long
she must pick up the remaining quantity as the pharmacy agrees to the terms and con-
within 6 months of the date on which the pre- ditions of the plan
scription was filled. b. Allows Rx to appear on a prescription instead
d. The pharmacist may provide the patient with of the federal legend
the requested amount but can give her the c. Insurance reform
balance only if there is a refill indicated on the d. Prohibits a prescription drug plan from re-
prescription. quiring mail order prescription drug coverage
without providing non–mail order coverage
110 Mosby’s Review for the Pharmacy Technician Certification Examination

19. Which organization oversees Medicare and Medic- 26. Which law stated that a resident’s drug regimen
aid service? must be free of unnecessary medications?
a. BOP a. Freedom of Choice Law
b. CMS b. HIPAA of 1996
c. DEA c. Omnibus Reconciliation Act of 1987
d. TJC d. Omnibus Reconciliation Act of 1990

20. Who reviews INDs? 27. Which law allows nasal inhalers to be dispensed
a. BOP without a child-resistant container?
b. DEA a. Americans with Disabilities Act
c. EPA b. Freedom of Choice Law
d. FDA c. Occupational Health and Safety Act of 1970
d. Poison Control Act of 1970
21. Which law required opium to have a prescription?
a. Comprehensive Drug Abuse Prevention and 28. Which law lowers the reimbursement rate for
Control Act of 1970 durable medical equipment?
b. Federal Food and Drug Act of 1906 a. Drug Price Competition and Patent Term
c. Food, Drug, and Cosmetic Act of 1938 Restoration Act
d. Harrison Narcotic Act of 1914 b. FDA Safe Medical Devices Act of 1990
22. Which law required that all narcotics be labeled d. Medicare Drug Improvement and Moderniza-
“Warning: May Be Habit Forming”? tion Act of 2003
a. Anabolic Steroid Control Act of 2004
b. Comprehensive Drug Abuse Prevention and 29. Which law prevents reimportation of medica-
Control Act of 1938 tion into the United States other than by a
c. Harrison Narcotic Act of 1914 manufacturer?
d. Prescription Drug Marketing Act of 1987 a. Drug Listing Act of 1972
b. Drug Price Competition and Patent Term
23. Which law requires drug utilization evaluation to Restoration Act of 1984
be performed on all prescriptions? c. Food, Drug, and Cosmetic Act of 1938
a. Dietary Supplement Health and Education d. Prescription Drug Marketing Act of 1987
Act of 1994
b. Omnibus Reconciliation Act of 1987 30. Which agency oversees the practice of pharmacy?
c. Omnibus Reconciliation Act of 1990 a. APhA
d. Prescription Drug Equity Law b. DEA
c. FDA
24. Which law allowed pharmacists to take pre- d. State BOP
scriptions over the telephone from a physician’s
office? 31. What classification of drug recall will cause seri-
a. Durham-Humphrey Act of 1950 ous adverse health consequences or death?
b. Food, Drug, and Cosmetic Act of 1938 a. Class I
c. Kefauver-Harris Act of 1962 b. Class II
d. Comprehensive Drug Abuse Prevention and c. Class III
Control Act of 1970 d. Class IV

25. Which law established tax-free savings accounts? 32. Which agency regulates the dispensing of radio-
a. Freedom of Choice Law pharmaceuticals?
b. HIPAA of 1996 a. DEA
c. Medicare Drug Improvement and Moderniza- b. FDA
tion Act of 2003 c. NABP
d. Omnibus Budget Reconciliation Act of 1990 d. NRC
Chapter 2 Pharmacy Law and Regulations 111

33. Which of the following addresses nonsterile 37. Which of the following is required to be found on
compounding? a manufacturer’s drug label?
a. ISO 9000 a. Control number
b. ,USP 790. b. Expiration date
c. ,USP 795. c. NDC number
d. ,USP 797. d. All of the above

34. Which organization determines the regulations 38. How long is a pharmacy’s DEA permit valid?
affecting generic substitution in state? a. 1 year
a. BOP b. 2 years
b. DEA c. 3 years
c. FDA d. 4 years
39. Which of the following is not found on a OTC
35. What is the maximum amount of pseudoephed- drug label?
rine base that may be purchased in 1 day? a. Beyond-use-date
a. 2.4 g b. Do not use for the following contraindications
b. 3.6 g c. Use(s)
c. 9 g d. Warnings
d. 10 g
40. Which of the following might indicate that
36. What is the first consideration of a pharmacy you have received a forged prescription for a
technician? controlled substance?
a. Assist and support the pharmacist in the safe, a. No abbreviations are found on the prescription
efficacious, and cost effective distribution of b. Prescription appears photocopied
health services. c. Quantity, directions, or dosage differs from
b. Ensure patients’ health and safety. the usual medical usage
c. Maintain professional competency. d. All of the above
d. Promote honesty and integrity within the
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