[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]


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

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.

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

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]
BILLING CODE 4160-01-F