[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Notices]
[Page 39880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19714]



[[Page 39880]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0514]


Draft Guidance for Industry on ANDA's: Impurities in Drug 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 
availability of a draft guidance for industry entitled ``ANDA's: 
Impurities in Drug Substances.'' This draft guidance provides 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DATES: Written comments on the draft guidance may be submitted by 
September 22, 1998. 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ADDRESSES: Copies of this draft guidance are available on the Internet 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''. Written requests for 
single copies of the draft guidance for industry should be submitted to 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 Submit written comments on the draft guidance to the Dockets 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, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert W. Trimmer, Office of Generic 
Drugs, 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 
draft guidance for industry entitled ``ANDA's: Impurities in Drug 
Substances.'' This draft guidance provides information on the 
following: (1) Qualifying impurities found in the drug substance used 
for ANDA via a comparison with impurities found in the related United 
States Pharmacopeia (USP) monograph, scientific literature, or 
innovator material; (2) qualifying impurities found at higher levels in 
the drug substance used for ANDA than found in the related USP 
monograph, scientific literature, or innovator material; (3) qualifying 
impurities in the drug substance used for ANDA which 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). The draft 
guidance 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 requirement of the applicable statute, regulations, or 
both.
    Interested persons may, on or before September 22, 1998, submit to 
the Dockets Management Branch (address above) written comments on the 
draft guidance. 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: July 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19714 Filed 7-23-98; 8:45 am]
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