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Sec. 480.100 Requirements for Expiration Dating and Stability Testing (CPG 7132a.04)

BACKGROUND:

Revisions to 21 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMP) introduced requirements concerning expiration dating (21 CFR 211.137) and stability testing (21 CFR 211.166) which became effective September 29, 1979. The purpose of this guide is to delineate those situations in which the Center is prepared to consider regulatory action.

POLICY:

If any of the following situations exist, recommend appropriate action (e.g., *warning letter or seizure) to HFD-300:*

1. Lack of assurance that a product labeled as sterile has been tested to ascertain that the container and closure can maintain a sterile state throughout the labeled shelf life.

2. Lack of a written stability program for bulk drug substances or an indication that it is either inadequate or not being followed.

3. Lack of an expiration date on finished dosage forms or a written stability program. See CPG 7132a.10 (Se Sec. 480.300).

4. Lack of a labeled date indicating stability after reconstitution or lack of studies to support the appropriateness of that date.

5. Lack of an ongoing testing program to verify product stability after the shelf life has been determined appropriate.

6. Lack of assurance that meaningful, specific, or reliable test methods and storage conditions are employed.

7. Lack of assurance that the currently marketed container or closure will provide adequate protection of the drug product.

8. Lack of follow-up studies at the labeled storage conditions or, if there are no storage conditions specified, at room temperature, for drug products for which the shelf life was determined by accelerated studies.

9. Lack of assurance of the effectiveness of any preservatives used throughout the labeled shelf life.

*10. Lack of an adequate number of batches (i.e., less than three) employed as the basis for either confirming a tentative expiration date or establishing the long-term stability of the product.

11. Distribution of product past the labeled expiration date.*

*Material between asterisks is new or revised*

Issued: 6/20/85
Reissued: 9/4/87, 3/95