Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-261 - Packaging and labeling

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Packaging and
			 labeling operations shall be adequately controlled, to assure that only those
			 products that have met the standards and specifications established in their
			 master production and control records shall be distributed; to prevent mixups
			 between products during filling, packaging, and labeling operations; to assure
			 that correct labels and labeling are employed for the product; and to identify
			 the finished product with a lot or control number that permits determination of
			 the history of the manufacture and control of the batch. An hour, day, or shift
			 code is appropriate as a lot or control number for all products manufactured or
			 processed in continuous production equipment. Packaging and labeling operations
			 shall:
(1) Be separated (physically or
			 spatially) from operations on other drugs in a manner adequate to avoid mixups
			 and minimize cross-contamination. Two (2) or more packaging or labeling
			 operations having amygdalin (laetrile) and other drugs, containers, or labeling
			 similar in appearance shall not be in process simultaneously on adjacent or
			 nearby lines unless these operations are separated either physically or
			 spatially.
(2) Provide for an
			 inspection of the facilities prior to use to assure that all drugs and
			 previously used packaging and labeling materials have been removed.
(3) Include the following labeling controls:
(A) The holding of labels and package
			 labeling upon receipt pending review and proofing against an approved final
			 copy by a competent and responsible individual to assure that they are accurate
			 regarding identity, content, and conformity with the approved copy before
			 release to inventory.
(B) The
			 maintenance and storage of each type of label and package labeling representing
			 different products, strength, dosage forms, or quantity of contents in such
			 manner as to prevent mixups and provide proper identification.
(C) A suitable system for assuring that only
			 current labels and package labeling are retained and that stocks of obsolete
			 labels and package labeling are destroyed.
(D) Restriction of access to labels and
			 package labeling to authorized personnel.
(E) Avoidance of gang printing of cut labels,
			 cartons, or inserts when the labels, cartons, or inserts are for different
			 products or different strengths of the same products or are of the same size
			 and have identical or similar format or color schemes. If gang printing is
			 employed, packaging and labeling operations shall provide for added control
			 procedures. These added controls should consider sheet layout, stacking,
			 cutting, and handling during and after printing.
(4) Provide strict control of the package
			 labeling issued for use with amygdalin (laetrile). Such issue shall be
			 carefully checked by a competent and responsible person for identity and
			 conformity to the labeling specified in the batch production record. Said
			 record shall identify the labeling and the quantities issued and used and shall
			 reasonably reconcile any discrepancy between the quantity of amygdalin
			 (laetrile) finished and the quantities of labeling issued. All excess package
			 labeling bearing lot or control numbers shall be destroyed. In event of any
			 significant unexplained discrepancy, an investigation should be carried out.
(5) Provide for adequate
			 examination or laboratory testing of representative samples of finished
			 products after packaging and labeling to safeguard against any errors in the
			 finishing operations and to prevent distribution of any batch until all
			 specified tests have been met.