Guidance for Industry on ANDA's: Impurities in Drug Substances; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0514]

Guidance for Industry on ANDA's: Impurities in Drug Substances;

Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

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availability of a guidance for industry entitled ``ANDA's: Impurities

in Drug Substances.'' This guidance provides recommendations for

including information in abbreviated new drug applications (ANDA's) and

supporting drug master files on the content and qualification of

impurities in drug substances produced by chemical syntheses for both

monograph and nonmonograph drug substances.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance are available on the Internet at

http://www.fda.gov/cder/guidance/index.htm. Submit written requests for

single copies of this 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. Send one

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

requests. Submit written comments on the guidance to the Dockets

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

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert W. Trimmer, Center for Drug

Evaluation and Research (HFD-625), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-5848.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

guidance for industry entitled ``ANDA's: Impurities in Drug

Substances.'' This guidance provides information on (1) Qualifying

impurities found in a drug substance used in an ANDA by a comparison

with impurities found in the related U.S. Pharmacopeia (USP) monograph,

scientific literature, or innovator material; (2) qualifying impurities

found at higher levels in a drug substance used for an ANDA than found

in the related USP monograph, scientific literature, or innovator

material; (3) qualifying impurities in a drug substance used for an

ANDA that are not found in the related USP monograph, scientific

literature, or innovator material; and (4) threshold levels below which

qualification is not needed.

In the Federal Register of July 24, 1998 (63 FR 39880), FDA

announced the availability of a draft version of this guidance. The

July 1998 document gave interested persons an opportunity to submit

comments through September 22, 1998. On October 19, 1998 (63 FR 55876),

in response to requests from the public, the agency reopened the

comment period until November 23, 1998. All comments received during

the comment period have been carefully reviewed and the guidance was

revised, where appropriate.

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

guidance practices (62 FR 8961, February 27, 1997). It represents the

agency's current thinking on the content and qualification of

impurities in drug substances produced by chemical syntheses that are

used in generic drug products. 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 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. 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: November 23, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 99-31316 Filed 12-2-99; 8:45 am]

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