[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Page 516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1168]


Draft Guidance for Industry on ANDA's: Impurities in Drug 
Products; 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availability of a draft guidance for industry entitled ``ANDA's: 
Impurities in Drug Products.'' This draft guidance provides 
recommendations for including information in abbreviated new drug 
applications (ANDA's) on the reporting, identification, and 
qualification of impurities in drug products produced from chemically 
synthesized drug substances for both monograph and nonmonograph drug 
products.

DATES: Written comments on the draft guidance may be submitted by May 
5, 1999. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm.'' Submit written 
requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Submit written comments on the draft guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5600 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Devinder S. Gill, Office of Generic 
Drugs, Center for Drug Evaluation and Research (HFD-623), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5848.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``ANDA's: Impurities in Drug 
Products.'' This draft guidance provides information for generic drug 
products on the following: (1) Qualifying degradation products via a 
comparison with impurities found in the related United States 
Pharmacopeia (USP) monograph, scientific literature, or innovator 
material; (2) qualifying degradation products found at higher levels in 
the generic drug product than found in the related USP monograph, 
scientific literature, or innovator material; (3) qualifying 
degradation products that are not found in the related USP monograph, 
scientific literature, or innovator material; and (4) threshold levels 
below which qualification is not needed.
     This draft 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 review of impurities in generic 
drug products produced from chemically synthesized drug substances. 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 submit written comments on the draft 
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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: December 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-31 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F