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Federal Register / Vol. 70, No.

103 / Tuesday, May 31, 2005 / Notices 30953

The Secretary of Health and Human for electronic access to the draft comparable to the USP standards on
Services has the discretion to allow guidance document. expiration dating of nonsterile unit-dose
Form FDA 1815, a duly certified FOR FURTHER INFORMATION CONTACT: repackaged drug products.
statement signed by an accredited Barry Rothman, Center for Drug In 2000, the USP revised its standards
official of a foreign government, to be Evaluation and Research (HFD–320), on the beyond-use dating of nonsterile
submitted in lieu of Forms FDA 1994 Food and Drug Administration, 5600 solid and liquid dosage forms that are
and 1995. To date, Form FDA 1815 has Fishers Lane, Rockville, MD 20857, packaged in single-unit and unit-dose
been submitted in lieu of these forms. 301–827–9026. containers. The USP now states that, for
such products, the beyond-use date
Dated: May 17, 2005. SUPPLEMENTARY INFORMATION:
must be 1 year from the date the drug
Jeffrey Shuren,
I. Background is packaged into the single-unit or unit-
Assistant Commissioner for Policy. dose container or the expiration date on
[FR Doc. 05–10703 Filed 5–27–05; 8:45 am] We are announcing the availability of
a draft guidance on ‘‘Expiration Dating the manufacturer’s container, whichever
BILLING CODE 4160–01–S
of Unit-Dose Repackaged Drugs.’’ The is earlier, unless stability data or the
manufacturer’s labeling indicates
document provides guidance on FDA’s
otherwise (USP 27, General Notices and
DEPARTMENT OF HEALTH AND enforcement policy regarding expiration
Requirements, at 11).
HUMAN SERVICES dating of repackaged nonsterile solid We have considered the USP revision
and liquid unit-dose drugs under to its beyond-use standard and believe
Food and Drug Administration § 211.137 (21 CFR 211.137). that similar conditions are appropriate
Specifically, the draft guidance states for CPG 7132b.11 for expiration dating.
[Docket No. 2005D–0174]
certain circumstances under which we We believe that under certain specified
Draft Guidance on Expiration Dating of intend to exercise enforcement conditions, it may be appropriate to
Unit-Dose Repackaged Drugs; discretion and do not intend to take assign up to a one-year expiration dating
Availability action against repackagers for failure to period to solid and liquid oral dosage
conduct stability studies to support form drug products repackaged into
AGENCY: Food and Drug Administration, expiration dates for drug products in unit-dose containers, without
HHS. accordance with FDA regulations. conducting new stability studies on the
ACTION: Notice. The draft guidance is a proposed repackaged drug products. Therefore,
revision of section 480.200 of the CPG we are proposing to revise CPG
SUMMARY: The Food and Drug (CPG 7132b.11), which we issued in
Administration (FDA) is announcing the 7132b.11 to clarify the agency’s exercise
February 1984 and revised in March of enforcement discretion concerning
availability of a draft guidance entitled 1995. We originally issued CPG
‘‘Expiration Dating of Unit-Dose expiration dating of nonsterile solid and
7132b.11 because unit-dose packaging liquid oral dosage form drug products
Repackaged Drugs.’’ The draft guidance systems had become widespread in
is a proposed revision of section that are repackaged into unit-dose
health care, and questions had arisen as containers.
480.200 of FDA’s Compliance Policy to whether drugs that were repackaged Under draft revised CPG 7132b.11, the
Guide (CPG) (CPG 7132b.11). We are into unit-dose containers needed expiration date for a nonsterile
proposing to revise CPG 7132b.11 so expiration dates based on stability data repackaged unit-dose drug would not
that FDA enforcement policy regarding on the drugs in the unit-dose containers. exceed the following: (1) One year from
expiration dating of nonsterile unit-dose The CGMP regulations require that the date of repackaging, or (2) the
repackaged drugs under the agency’s each drug product bear an expiration expiration date on the container of the
current good manufacturing practice date derived from tests conducted on original manufacturer’s product,
(CGMP) regulations is substantially samples stored in the immediate whichever is earlier, unless stability
comparable to the expiration dating container closure system in which the data or the original manufacturer’s
standards for such drugs set forth in the drug is marketed (see § 211.137(a), product labeling indicated otherwise,
U.S. Pharmacopeia (USP). § 211.166(a)(4) (21 CFR 211.166(a)(4))). and provided certain other
DATES: Submit written or electronic This expiration dating ensures the recommendations specified in CPG
comments on the draft guidance by drugs’ safety and efficacy over their 7132b.11 were met. These other
August 29, 2005. General comments on intended shelf life. CPG 7132b.11 notes conditions include, but are not limited
agency guidance documents are that the USP contains standards on to, standards for containers, repackaging
welcome at any time. beyond-use dating of nonsterile solid operations, and the repackaging
ADDRESSES: Submit written requests for and liquid unit-dose drug products. environment.
single copies of the draft guidance to the Since its adoption in 1984, the CPG Additionally, because CPG 7132b.11
Division of Drug Information (HFD– has stated that, in light of the USP serves as Attachment B to section
240), Center for Drug Evaluation and standards and under certain conditions, 430.100 of the CPG (CPG 7132b.10,
Research, Food and Drug the agency does not deem it necessary ‘‘Unit Dose Labeling for Solid and
Administration, 5600 Fishers Lane, that stability studies be conducted on Liquid Oral Dosage Forms’’), the
Rockville, MD 20857. Send one self- drugs that are repackaged into unit-dose proposed revision of CPG 7132b.11 will
addressed adhesive label to assist that containers. Therefore, the CPG has serve as Attachment B to CPG 7132b.10
office in processing your requests. stated that we do not intend to initiate when CPG 7132b.11 is finalized.
Submit written comments on the draft enforcement action against any unit- We invite comments on the draft
guidance to the Division of Dockets dose repackaging firm for failure to have guidance. Additionally, we intend to
Management (HFA–305), Food and Drug stability studies supporting expiration conduct further study of the
Administration, 5630 Fishers Lane, rm. dates, provided certain conditions are appropriateness of the proposed
1061, Rockville, MD 20852. Submit met, including that the expiration date revision of CPG 7132b.11 regarding
electronic comments to http:// does not exceed 6 months. At the time expiration dating on the unit-dose
www.fda.gov/dockets/ecomments. See the CPG was adopted, this containers of nonsterile repackaged
the SUPPLEMENTARY INFORMATION section recommendation was substantially solid and liquid oral dosage form drug

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30954 Federal Register / Vol. 70, No. 103 / Tuesday, May 31, 2005 / Notices

products. We do not intend to make a as amended. The grant applications and Name of Committee: National Center for
final decision on the proposed revision the discussions could disclose Complementary and Alternative Medicine
of CPG 7132b.11 until we complete confidential trade secrets or commercial Special Emphasis Panel Meeting Conflict.
Date: June 24, 2005.
further study of the expiration dating property such as patentable material, Time: 12 p.m. to 5 p.m.
issue to determine the most and personal information concerning Agenda: To review and evaluate grant
scientifically sound approach. We invite individuals associated with the grant applications.
interested persons to submit data applications, the disclosure of which Place: NIH/NCCAM, Democracy II, 6707
establishing appropriate expiration would constitute a clearly unwarranted Democracy Blvd., Suite 401, Bethesda, MD
dating for such drug products. invasion of personal privacy. 20892.
This draft guidance is being issued Contact Person: Jeanette M. Hosseini,
Name of Committee: National Cancer Scientific Review Administrator, National
consistent with FDA’s good guidance Institute Initial Review Group, Subcommittee Center for Complementary and Alternative
practices regulation (21 CFR 10.115). A—Cancer Center. Medicine, 6707 Democracy Blvd, Suite 401,
The draft guidance, when finalized, will Date: August 4–5, 2005. Bethesda, MD 20892, (301) 594–9096.
represent the agency’s current thinking Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant Dated: May 19, 2005.
on expiration dating on nonsterile unit-
dose repackaged drug products. It does applications. LaVerne Y. Stringfield,
not create or confer any rights for or on Place: Marriott Bethesda North Hotel, 5701 Director, Office of Federal Advisory
Marinelli Road, Bethesda, MD 20852. Committee Policy.
any person and does not operate to bind
Contact Person: David E. Maslow, PhD, [FR Doc. 05–10753 Filed 5–27–05; 8:45 am]
FDA or the public. An alternative Scientific Review Administrator, Resources
approach may be used if such approach and Training Review Branch, Division of
BILLING CODE 4140–01–M
satisfies the current requirements of the Extramural Activities, National Cancer
applicable statutes and regulations. Institute, 6116 Executive Blvd., Room 8117,
Bethesda, MD 20892–7405, (301) 496–2330, DEPARTMENT OF HEALTH AND
II. Comments dm65y@nih.gov. HUMAN SERVICES
Interested persons may submit to the (Catalogue of Federal Domestic Assistance
Division of Dockets Management (see National Institutes of Health
Program Nos. 93.392, Cancer Construction;
ADDRESSES) written or electronic 93.393, Cancer Cause and Prevention National Center on Minority Health and
comments on the draft guidance. Submit Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Health Disparities; Notice of Meeting
a single copy of electronic comments or
two paper copies of any mailed Treatment Research; 93.396, Cancer Biology Pursuant to section 10(d) of the
Research; 93.397, Cancer Centers Support; Federal Advisory Committee Act, as
comments, except that individuals may 93.398, Cancer Research Manpower; 93.399,
submit one paper copy. Comments are amended (5 U.S.C. Appendix 2), notice
Cancer Control, National Institutes of Health,
to be identified with the docket number HHS)
is hereby given of a meeting of the
found in brackets in the heading of this National Advisory Council on Minority
Dated: May 19, 2005. Health and Health Disparities.
document. The draft guidance and
received comments may be seen in the LaVerne Y. Stringfield, The meeting will be open to the
Division of Dockets Management Director, Office of Federal Advisory public as indicated below, with
between 9 a.m. and 4 p.m., Monday Committee Policy. attendance limited to space available.
through Friday. [FR Doc. 05–10755 Filed 5–27–05; 8:45 am] Individuals who plan to attend and
BILLING CODE 4140–01–M need special assistance, such as sign
III. Electronic Access language interpretation or other
Persons with access to the Internet reasonable accommodations, should
may obtain the documents at http:// DEPARTMENT OF HEALTH AND notify the Contact Person listed below
www.fda.gov/cder/guidance/index.htm HUMAN SERVICES in advance of the meeting.
or http://ohrms/dockets/default.htm. The meeting will be closed to the
National Institutes of Health public in accordance with the
Dated: May 19, 2005.
provisions set forth in sections
Jeffrey Shuren, National Center for Complementary & 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Assistant Commissioner for Policy. Alternative Medicine; Notice of Closed as amended. The grant applications and
[FR Doc. 05–10702 Filed 5–27–05; 8:45 am] Meeting the discussions could disclose
BILLING CODE 4160–01–S confidential trade secrets or commercial
Pursuant to section 10(d) of the property such as patentable material,
Federal Advisory Committee Act, as and personal information concerning
DEPARTMENT OF HEALTH AND amended (5 U.S.C. Appendix 2), notice individuals associated with the grant
HUMAN SERVICES is hereby given of the following applications, the disclosure of which
meeting. would constitute a clearly unwarranted
National Institutes of Health The meeting will be closed to the invasion of personal privacy.
public in accordance with the Name of Committee: National Advisory
National Cancer Institute; Notice of
provisions set forth in sections Council on Minority Health and Health
Closed Meeting
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Disparities.
Pursuant to section 10(d) of the as amended. The grant applications and Date: June 21, 2005.
Federal Advisory Committee Act, as the discussions could disclose Open: 8:30 a.m. to 4 p.m.
amended (5 U.S.C. Appendix 2), notice confidential trade secrets or commercial Agenda: The agenda will include Opening
is hereby given of the following property such as patentable material, Remarks, Administrative Matters, Director’s
and personal information concerning Report, NCMHD, National Academy of
meeting. Sciences Report on Assessment of NIH
The meeting will be closed to the individuals associated with the grant Minority Research an Training Programs,
public in accordance with the applications, the disclosure of which NIH IC Health Disparities Research Report,
provisions set forth in sections would constitute a clearly unwarranted NCMHD Program Highlights, other business
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. of the Council.

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