Kan. Admin. Regs. § 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.
Notes
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