Kan. Admin. Regs. § 28-21-265

Current through Register Vol. 43, No. 46, November 14, 2024

Section 28-21-265 - Reference laboratory control

(a) Manufacturers of amygdalin (laetrile) shall submit to the state department of health and environmental laboratories, prior to release of any lot number of amygdalin (laetrile) to wholesalers or physicians, 10 (ten) ampules or vials of injectable amygdalin (laetrile) and 25 (twenty-five) tablets and capsules of each dosage size produced from each lot number of amygdalin (laetrile) produced.

(b) Manufacturers of amygdalin (laetrile) shall certify in writing which shall accompany control samples of each lot number submitted to the state department of health and environmental laboratories that the product is free of bacterial and fungal contamination, pyrogenic agents, and all adulterants including but not limited to isopropyl and methyl alcohols. Autoclaving which causes stereochemical inversion of the mandelonitrile portion of amygdalin shall not be permitted.

(c) Any lot number of amygdalin (laetrile) found to contain impurities, microbial or fungal contamination, pyrogens, or other toxic substances shall be destroyed immediately. No lot number of amygdalin (laetrile) shall be released for distribution and use until approved and certified by the secretary of health and environment.

Kan. Admin. Regs. § 28-21-265

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