Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-256 - Components

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) All components
			 and other materials used in the manufacture, processing, and packaging of
			 amygdalin (laetrile), and materials necessary for building and equipment
			 maintenance, upon receipt shall be stored and handled in a safe, sanitary, and
			 orderly manner. Adequate measures shall be taken to prevent mixups and
			 cross-contamination affecting the components and final product. Components
			 shall be withheld from use until they have been identified, sampled, and tested
			 for conformance with established specifications and are released by a materials
			 approval unit. Control of components shall include the following:
(1) Each container of component shall be
			 examined visually for damage or contamination prior to use, including
			 examination for breakage of seals when indicated.
(2) An adequate number of samples shall be
			 taken from a representative number of component containers from each lot and
			 shall be subjected to one (1) or more tests to establish the specific identity.
(3) Representative samples of
			 components liable to contamination with filth, insect infestation, or other
			 extraneous contaminants shall be appropriately examined.
(4) Representative samples of all components
			 intended for use as active ingredients shall be tested to determine their
			 strength in order to assure conformance with appropriate speculations.
(5) Representative samples of
			 components liable to microbiological contamination shall be subjected to
			 microbiological tests prior to use. Such components shall not contain
			 microorganisms that are objectionable in view of their intended use.
(6) Approved components shall be
			 appropriately identified and retested as necessary to assure that they conform
			 to appropriate specifications of identity, strength, quality, and purity at
			 time of use. This requires the following:
(A)
			 Approved components shall be handled and stored to guard against contaminating
			 or being contaminated by other drugs or components.
(B) Approved components shall be rotated in
			 such a manner that the oldest stock is used first.
(C) Rejected components shall be identified
			 and held to preclude their use in manufacturing or processing procedures for
			 which they are unsuitable.
(7) Appropriate records shall be maintained,
			 including the following:
(A) The identity and
			 quantity of the component, the name of the supplier, the supplier's lot number,
			 and the date of receipt.
(B)
			 Examinations and tests performed and rejected components and their disposition.
(C) An individual inventory and
			 record for each component used in each batch of amygdalin (laetrile)
			 manufactured or processed.
(8) An appropriately identified reserve
			 sample of all active ingredients consisting of at least twice the quantity
			 necessary for all required tests, except those for sterility and determination
			 of the presence of pyrogens, shall be retained for at least two (2) years after
			 distribution of the last lot incorporating the component has been completed or
			 one (1) year after the expiration date of this last lot, whichever is longer.