Kan. Admin. Regs. § 28-21-259

Current through Register Vol. 43, No. 49, December 5, 2024

Section 28-21-259 - Stability

There shall be assurance of the stability of finished amygdalin (laetrile) products. This stability shall be:

(1) Determined by reliable, meaningful, and specific test methods.

(2) Determined on products in the same container-closure system 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.

Kan. Admin. Regs. § 28-21-259

Authorized by K.S.A. 1978 Supp. 65-6b06, 65-6b07; effective May 1, 1979.