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