ANDA'S: Impurities in Drug Products; availability,

[Federal Register: January 5, 1999 (Volume 64, Number 2)]

[Notices]

[Page 516]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05ja99-78]

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Draft Guidance for Industry on ANDA's: Impurities in Drug Products; Availability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.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA's: Impurities in Drug Products.'' This draft guidance provides recommendations for including information in abbreviated new drug applications (ANDA's) on the reporting, identification, and qualification of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DATES: Written comments on the draft guidance may be submitted by May 5, 1999.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ADDRESSES: Copies of this draft guidance are available on the Internet at ``http://www.fda.gov/cder/guidance/index.htm.'' Submit written requests for single copies of the draft guidance to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20852.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SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a draft guidance for industry entitled ``ANDA's: Impurities in Drug Products.'' This draft guidance provides information for generic drug products on the following: (1) Qualifying degradation products via a comparison with impurities found in the related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. 99-31Filed1-4-99; 8:45 am]

BILLING CODE 4160-01-F