[Federal Register Volume 62, Number 77 (Tuesday, April 22, 1997)]
[Notices]
[Pages 19580-19581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10342]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0422]
Guidance for Industry: Current Good Manufacturing Practices for
Positron Emission Tomographic (PET) Drug Products; 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 entitled ``Guidance for Industry: Current
Good Manufacturing Practices for Positron Emission Tomographic (PET)
Drug Products'' prepared by FDA's Center for Drug Evaluation and
Research (CDER). The guidance is intended to assist persons involved in
the production of PET radiopharmaceutical drug products in achieving
compliance with FDA's current good manufacturing practice (CGMP)
regulations for finished pharmaceuticals.
DATES: Persons may submit written comments on the guidance at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Current Good Manufacturing Practices
for Positron Emission Tomographic (PET) Drug Products'' 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. An electronic version of this guidance is
available via Internet using the World Wide Web (WWW). To connect to
the CDER home page, type ``http://www.fda.gov/cder'' and go to the
``Regulatory Guidance'' section. Submit written comments on the
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. A copy of 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.
FOR FURTHER INFORMATION CONTACT: Robert K. Leedham, Center for Drug
Evaluation and Research (HFD-343), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-594-1026.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance entitled ``Guidance for Industry: Current Good Manufacturing
Practices for Positron Emission Tomographic (PET) Drug Products.'' PET
is a medical imaging modality used to assess the body's biochemical
processes. Radionuclides are manufactured into PET radiopharmaceutical
drug products that are administered to patients for medical imaging.
The images of the body's biochemical processes are then evaluated,
generally for diagnostic purposes.
In the Federal Register of February 27, 1995 (60 FR 10593), FDA
announced the availability of its ``Draft Guideline on the Manufacture
of Positron Emission Tomographic (PET) Drug Products.'' The notice gave
interested persons an opportunity to submit comments by May 30, 1995.
FDA received comments from more than 20 persons. The final PET CGMP
guidance
[[Page 19581]]
contains revisions incorporating many of those comments.
The PET CGMP guidance discusses the requirements for manufacturing
practices, procedures, and facilities used to prepare PET
radiopharmaceuticals. The guidance addresses such matters as quality
control units, personnel qualifications, staffing, buildings and
facilities, equipment, components, containers, closures, production and
process controls, packaging and labeling controls, holding and
distribution, testing and release for distribution, stability testing
and expiration dating, reserve samples, yields, second-person checks,
reports, and records. The guidance focuses particular attention on CGMP
requirements that are of special concern due to unique characteristics
inherent in the production and control of PET radiopharmaceuticals.
PET radiopharmaceutical drug product manufacturing differs in a
number of important ways from the manufacture of conventional drug
products:
(1) Because of the short physical half-lives of PET
radiopharmaceuticals, PET facilities generally manufacture the products
in response to daily demand for a relatively small number of patients.
(2) Manufacturing may be limited and only a few lots produced each
day.
(3) PET radiopharmaceuticals must be administered to patients
within a short period of time after manufacturing because of the short
half-lives of the products.
FDA recognized that, because of these differences, application of
certain provisions of the CGMP regulations in part 211 (21 CFR part
211) to the manufacture of PET radiopharmaceuticals might result in
unsafe handling or be otherwise inappropriate. Therefore, elsewhere in
this issue of the Federal Register, the agency is publishing a final
rule authorizing manufacturers of PET radiopharmaceuticals to apply to
the agency for exceptions or alternatives to provisions of the CGMP
regulations. The PET CGMP guidance notes that while the CGMP
regulations apply to the manufacture of PET radiopharmaceuticals, new
Sec. 211.1(d) permits manufacturers of such drugs to request an
exception or alternative to any requirement in part 211.
This guidance represents the agency's current thinking on CGMP's
for PET radiopharmaceuticals. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. A
regulated entity may adopt an alternative approach to CGMP's for PET
drugs if such approach satisfies the requirements of the Federal Food,
Drug, and Cosmetic Act and FDA regulations.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. If
written comments demonstrate that changes to the final guidance are
appropriate, FDA will revise the guidance accordingly. 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 guidance and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 15, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-10342 Filed 4-21-97; 8:45 am]
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