Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0268]

Guidance for Industry on Container Closure Systems for Packaging

Human Drugs and Biologics; Chemistry, Manufacturing, and Controls

Documentation; 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 guidance for industry entitled ``Container Closure

Systems for Packaging Human Drugs and Biologics; Chemistry,

Manufacturing, and Controls Documentation.'' This guidance provides

recommendations on the container closure systems information that

applicants should provide to the Center for Drug Evaluation and

Research (CDER) and the Center for Biologics Evaluation and Research

(CBER) in support of new drug applications, abbreviated new drug

applications, biologics license applications, and supplements to these

applications.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance for industry are available on the

Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://

www.fda.gov/cber/guidelines.htm''. Submit written requests for single

copies of the guidance for industry to the Drug Information Branch

(HFD-210), Center for Drug Evaluation and Research, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, or to the

Office of Communication, Training and Manufacturers Assistance (HFM-

40), Center for Biologics Evaluation and Research, Food and Drug

Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one

self-addressed adhesive label to assist the office in processing your

requests. Submit written comments on the draft guidance to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers

Lane, rm 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

W. Mike Adams, Center for Drug Evaluation and Research (HFD-180),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,

301-827-7310, or

John D. Finkbohner, Center for Biologics Evaluation and Research

(HFM-676), Food and Drug Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301827-3031.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

guidance for industry entitled ``Container Closure Systems for

Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and

Controls Documentation.'' This guidance provides recommendations on the

container closure system information that applicants should provide to

CDER or CBER for initial applications and supplements. In addition, the

document provides guidance on qualification and quality control of

packaging components used for particular dosage forms and routes of

administration, including the following: 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. This guidance

supersedes the agency's ``Guideline for Submitting Documentation for

Packaging for Human Drugs and Biologics,'' issued February 1987.

This Level 1 guidance is being issued consistent with FDA's good

guidance practice (62 FR 8961, February 27, 1997). In the Federal

Register of July 15, 1997 (62 FR 37925), FDA announced the availability

of a draft version of this guidance. The July 1997 document gave

interested persons an opportunity to submit comments through September

15, 1997. On September 5, 1997, in response to requests from the

public, the agency extended the comment period until November 14, 1997

(62 FR 46980). All comments received during the comment period have

been carefully reviewed and incorporated in this revised guidance where

appropriate. As a result of public input during the comment period, the

final guidance is clearer and more concise than the draft version. The

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. An alternative approach may be used if such approach satisfies

the requirements of the applicable statute, regulations, or both.

Interested persons may, at any time, submit written comments on the

guidance to the Dockets Management Branch (address above). Two copies

of

[[Page 36695]]

any comments are to 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. A copy of the guidance and received comments are available

for public examination in the Dockets Management Branch between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: June 29, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy Coordination.

[FR Doc. 99-17157 Filed 7-6-99; 8:45 am]

BILLING CODE 4160-01-F