[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Draft Guidance for Industry; Submission of Documentation in Drug 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availability of a draft guidance entitled ``Guidance for Industry: 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draft guidance was prepared by FDA's Center for Drug Evaluation and 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 The draft guidance discusses information on container closure 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 The draft guidance, when completed, will 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agency requests comments on the draft guidance.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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Submission of Documentation 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 Submit written comments on the draft guidance to the Dockets 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