[Federal Register Volume 63, Number 229 (Monday, November 30, 1998)]
[Notices]
[Pages 65793-65794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31765]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0994]


Draft Guidance for Industry on BACPAC I: Intermediates in Drug 
Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, 
Manufacturing, and Controls Documentation; 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availability of a draft guidance for industry entitled ``BACPAC I: 
Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval 
Changes: Chemistry, Manufacturing, and Controls Documentation.'' This

[[Page 65794]]

draft guidance provides recommendations to sponsors of new drug 
applications, abbreviated new drug applications, new animal drug 
applications, abbreviated new animal drug applications, and holders of 
drug master files or veterinary master files who intend, during the 
postapproval period, to change the site of manufacture, the scale of 
manufacture, the equipment, the specifications, and/or the 
manufacturing process of intermediates in the synthetic pathway leading 
to the drug substance.

DATES:  Written comments on the draft guidance may be submitted by 
March 31, 1999. General comments on the 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ADDRESSES:  Copies of this draft guidance are available on the Internet 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'' or ``http://
www.fda.gov/cvm''. 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draft guidance to the Drug Information Branch (HFD-210), Center for 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. Send one self-addressed adhesive 
label to assist that office in processing your requests. 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comments on the draft guidance to the Dockets Management Branch (HFA-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. Comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Kasturi Srinivasachar, Center for 
Drug Evaluation and Research (HFD-110), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-594-5376, or David R. 
Newkirk, Center for Veterinary Medicine (HFV-142), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2701.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
draft guidance entitled ``BACPAC I: Intermediates in Drug Substance 
Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, 
and Controls Documentation.'' This draft guidance defines recommended 
chemistry, manufacturing and controls tests, and documentation in 
support of each change. The draft guidance applies to synthetic drug 
substances and the synthetic steps involved in the preparation of 
semisynthetic drug substances. It is limited to structurally well-
characterized drug substances where impurities can be monitored at the 
levels recommended. The draft guidance covers changes as follows: (1) 
Site, scale, and equipment changes involving the synthetic steps up to 
and including the step that produces the final intermediate, (2) 
specification changes for raw materials, starting materials, and 
intermediates, excluding the final intermediate, and (3) manufacturing 
process changes involving the synthetic steps up to and including the 
final intermediate. Postapproval changes affecting: (1) Synthetic 
peptides, (2) oligonucleotides, (3) radiopharmaceuticals, or (4) drug 
substances derived exclusively by isolation from natural sources or 
produced by procedures involving biotechnology are not addressed in 
this document.
     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 postapproval 
changes for the manufacture of intermediates in drug substance 
syntheses. 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 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: November 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-31765 Filed 11-27-98; 8:45 am]
BILLING CODE 4160-01-F