[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Notices]
[Pages 37925-37926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0268]
Draft Guidance for Industry; Submission of Documentation in Drug
Applications for Container Closure Systems Used for the Packaging of
Human Drugs and Biologics; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Submission of Documentation in Drug Applications for Container Closure
Systems Used for the Packaging of Human Drugs and Biologics.'' This
draft guidance was prepared by FDA's Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER). The draft guidance discusses information on container closure
systems used in packaging drugs that manufacturers should provide to
CDER in meeting regulatory requirements for new drug applications
(NDA's), abbreviated new drug applications (ANDA's), investigational
new drug applications (IND's), abbreviated antibiotic applications
(AADA's), and supplements to these applications, and to CBER in meeting
requirements for biologics license applications (BLA's) and product
license applications (PLA's). The draft guidance, when completed, will
supersede the agency's ``Guideline for Submitting Documentation for
Packaging for Human Drugs and Biologics,'' issued February 1987. The
agency requests comments on the draft guidance.
DATE: Written comments by September 15, 1997. General comments on
agency guidance documents are welcomed at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Submission of Documentation
in Drug Applications for Container Closure Systems Used for the
Packaging of Human Drugs and Biologics'' to the Drug Information Branch
(HFD-210), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your
request. Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Alan C. Schroeder, Center for Drug
Evaluation and Research (HFD-570), 5600 Fishers Lane, Rockville MD
20857, 301-827-1050.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance entitled ``Guidance for Industry: Submission of
Documentation in Drug Applications for Container Closure Systems Used
for Packaging of Human Drugs and Biologics.'' The guidance discusses
information on container closure systems used in packaging drugs that
manufacturers should provide to CDER and CBER in meeting regulatory
requirements for initial applications, amendments, and supplements.
The Federal Food, Drug, and Cosmetic Act (the act) authorizes FDA
to establish standards for drug product packaging, including containers
and closures. According to section 501(a)(3) of the act (21 U.S.C.
351(a)(3)), a drug is deemed to be adulterated if its container is
composed, in whole or part, of any poisonous or deleterious substance
which may render the contents injurious to health * * *. Under section
505(b)(1)(D) of the act (21 U.S.C. 355(b)(1)(D)), an application for
approval to market a new drug must include ``a full description of the
methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug.'' FDA's regulations
on current good manufacturing practices for the control of drug product
containers and closures are set forth in subpart E of part 211 (21 CFR
part 211). In particular, Sec. 211.94 states that finished drug
manufacturers must establish and follow ``[s]tandards or
specifications, methods of testing, and, where indicated, methods of
cleaning, sterilizing, and processing to remove pyrogenic properties *
* * for drug product containers and closures.''
In February 1987, FDA issued a ``Guideline for Submitting
Documentation for Packaging for Human Drugs and Biologics.'' The
guideline was intended to provide drug manufacturers with guidance on
preparing information on the fabrication and quality of containers and
container components for use in the submission of NDA's, ANDA's, IND's,
or PLA's.
The draft ``Guidance for Industry: Submission of Documentation in
Drug Applications for Container Closure Systems Used for Packaging of
Human Drugs and Biologics'' revises and updates the February 1987
guideline to reflect innovations in drug product container closure
systems that have occurred in the past decade. In addition, the
document provides more extensive guidance on qualification and quality
control of packaging components used with drug products having
particular dosage forms and routes of administration, including the
following: Inhalation drug products, drug products for injection and
ophthalmic drug products, liquid-based oral and topical drug products
and topical delivery systems, solid oral dosage forms and powders for
reconstitution, and other dosage forms. The draft guidance also
addresses post-approval packaging changes, Type III drug master files,
and bulk containers. The draft guidance, when completed, will supersede
the 1987 guideline.
This draft guidance represents the agency's current thinking on
submitting information in drug applications on container closure
systems used in packaging human drugs and biologics. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. A regulated entity may adopt an alternative approach
to submitting information on container closure systems if such approach
satisfies the applicable statutory and regulatory requirements.
Interested persons may, on or before September 15, 1997, submit to
the Dockets Management Branch (address above) written comments on the
draft guidance. Two copies of any comments should be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in
the heading of this document. The draft guidance and received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday. An electronic version of this draft guidance is
available via Internet using the World Wide Web (WWW) at http://
www.fda.gov/cder/guidance.htm.
[[Page 37926]]
Dated: July 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18460 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F