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

[Federal Register Volume 64, Number 232 (Friday, December 3, 1999)]
[Notices]
[Pages 67917-67918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31316]


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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

[[Page 67918]]

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]
BILLING CODE 4160-01-F