[Federal Register: February 16, 2001 (Volume 66, Number 33)]
[Notices]
[Page 10699-10700]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe01-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D 0994]
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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``BACPAC I:
Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval
Changes: Chemistry, Manufacturing, and Controls Documentation.'' This
guidance provides recommendations to holders of new drug applications,
abbreviated new drug applications, new animal drug applications,
abbreviated new animal drug applications, and 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 specification(s), and/or the manufacturing process of
intermediates in the synthetic pathway leading to the drug substance.
DATES: Submit written comments on agency guidances at any time.
ADDRESSES: Submit written requests for single copies of this 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
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance 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 Dennis M. Bensley,
Center for Veterinary Medicine (HFV-143), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 301-827-6956.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``BACPAC I: Intermediates in Drug Substance Synthesis; Bulk
Actives Postapproval Changes: Chemistry, Manufacturing, and Controls
Documentation.'' This guidance describes chemistry, manufacturing, and
controls information and documentation in support of each change and
provides recommendations on reporting categories. The 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 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. The guidance does not cover
postapproval changes affecting: (1) Synthetic peptides, (2)
oligonucleotides, (3) radiopharmaceuticals, (4) drug substances derived
exclusively by isolation from natural sources or produced by procedures
involving biotechnology, or (5) nonsynthetic steps for semisynthetic
drug substances. Also excluded from this guidance are certain changes
in specification and process associated with the use of raw materials
or starting materials derived from natural sources or biotechnology.
In the Federal Register of November 30, 1998 (63 FR 65793), FDA
announced the availability of a draft version of this guidance. The
November 1998 guidance gave interested persons an opportunity to submit
comments through March 31, 1999. All comments received during the
comment period have been carefully reviewed and incorporated in this
revised guidance where appropriate. As a result of the public comment,
the guidance is clearer and more concise than the draft version.
This Level 1 guidance is being issued consistent with FDA's good
guidance
[[Page 10700]]
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000).
The guidance represents the agency's current thinking on intermediates
in drug substance synthesis, bulk actives postapproval changes,
chemistry, manufacturing, and controls documentation. 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 statutes and
regulations.
II. Comments
Interested persons may, at any time, submit written comments on the
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 guidance. The guidance and received
comments are available for public examination in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cvm.
Dated: February 8, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3956 Filed 2-15-01; 8:45 am]
BILLING CODE 4160-01-F