Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS
Section 25.21 - Stability
Current through Register Vol. 54, No. 44, November 2, 2024
There shall be assurance of the stability of finished drug products. This stability shall be in accordance with the following:
(1) Determined by reliable, meaningful, and specific test methods.
(2) Determined on products in the same container closure systems in which they are marketed.
(3) Determined on any dry drug product that is to be reconstituted at the time of dispensing, as directed in its labeling, as well as on the reconstituted product.
(4) Recorded and maintained in such manner that the stability data may be utilized in establishing product expiration dates.
This section cited in 28 Pa. Code § 25.11 (relating to buildings); and 28 Pa. Code § 25.22 (relating to expiration date).
