Guidance for Industry: Current Good Manufacturing Practices for Positron Emission Tomographic (PET) Drug Products; Availability

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]

BILLING CODE 4160-01-F