[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Draft Guidance for Industry on ANDA's: Impurities in Drug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availability of a draft guidance for industry entitled ``ANDA's: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 This draft guidance provides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DATES: Written comments on the draft guidance may be submitted by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ADDRESSES: Copies of this draft guidance are available on the Internet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single copies of the draft guidance for industry should be submitted to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 Submit written comments on the draft guidance to the Dockets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draft guidance for industry entitled ``ANDA's: Impurities in Drug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 This draft guidance provides information on the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]
BILLING CODE 4160-01-F
