Section 25.21. Stability

Latest version.

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.

Notation

Cross References

This section cited in 28 Pa. Code § 25.11 (relating to buildings); and 28 Pa. Code § 25.22 (relating to expiration date).

                    
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