Agency 28, Article 21 — FOOD, DRUGS

(Authorized by K.S.A. 1965 Supp. 65-673; effective Jan. 1, 1966; revoked June 4, 2010.)

(Authorized by K.S.A. 65-665 (j), K.S.A. 1965 Supp. 65-673; effective Jan. 1, 1966; revoked June 4, 2010.)

(Authorized by K.S.A. 1968 Supp. 65-673; effective Jan. 1, 1969; revoked May 10, 1996.) 28-21-109 to 28-21-111. (Authorized by K.S.A. 1968 Supp. 65-673; effective Jan. 1, 1969; revoked May 10, 1996.)

(Authorized by K.S.A. 65-665 (k), K.S.A. 1965 Supp. 65-673; effective Jan. 1, 1966; revoked June 4, 2010.) B. WHEAT FLOUR AND RELATED PRODUCTS

(Authorized by K.S.A. 1968 Supp. 65-673; effective Jan. 1, 1969; revoked May 10, 1996.) I. DRUGS AND THERAPEUTIC DEVICES

(Authorized by K.S.A. 1965 Supp. 65-673; effective Jan. 1, 1966; revoked Feb. 8, 2013.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

Drugs; name. (a) The name by which a drug is designated shall be clearly dis- tinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name…

Drugs and devices; labeling, misbranding. (a) Among representations in the labeling of a drug or device which render such drug or device misbranded is a false or misleading representation with respect to another drug or de- vice or a food or cosmetic. (b) The labeling of a drug w…

Drugs and devices; labeling requirements. (a) If a drug or device is not man- ufactured by the person whose name appears on the label, the name shall be qualified by a phrase which reveals the connection such person has with such drug or device, such as “Manufactured for and Pack…

Drugs and devices; forms of making required statements. (a) A word, state- ment, or other information required by or under authority of the Act to appear on the label may lack that prominence and conspicuousness re- quired by K.S.A. 65-669(c) by reason (among oth- er reasons) of:…

Habit-forming drugs; label requirements. (a)(1) The name of a substance 499 Food, Drugs and Cosmetics 28-21-205 or derivative required to be borne on the label of a drug by K.S.A. 65-669(d) shall be the common or usual name of such substance or derivative, unless it is designated…

Drugs; statement of ingre- dients and proportion. (a)(1) The name of an ingredient, substance, derivative, or preparation required by K.S.A. 65-669(e)(1)(ii) to be borne on the label of a drug shall be the name thereof, which is listed in K.S.A. 65-669(e)(1)(ii), or, if not so li…

Drugs and devices; direc- tions for use. (a) Adequate directions for use. “Adequate directions for use” means directions under which the layman can use a drug or device safely and for the purposes for which it is intend- ed. Directions for use may be inadequate because (among oth…

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.) 493 Food, Drugs and Cosmetics 28-21-40

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

Definitions. (a) The term “laetrile” (with a small l) is a generic term which is used interchangeably with “Laetrile,” “nitrilo- side,” “amygdalin,” “vitamin B-17” and related compounds of unknown number. The term is also used to include a number of these compounds, in which case…

Manufacturing practice. (a) The criteria in each section of this regulation shall applyindeterminingwhetherthemethodsusedin, or the facilities or controls used for, the manufac- ture, processing, packing, or holding of the product conform to or are operated or administered in con…

Personnel. (a) The personnel responsible for directing the manufacture and control of amygdalin (laetrile) shall be adequate in number and background of education, training and experience, or combination thereof, to assure that the product has the safety, identity, strength, qual…

Buildings or facilities. (a) Buildings shall be maintained in a clean and or- derly manner and shall be of suitable size, con- struction, and location to facilitate adequate cleaning, maintenance, and proper operations in the manufacturing, processing, packing, labeling, or holdi…

Equipment. (a) Equipment used for the manufacture, processing, packing, labeling, holding, testing, or control of amygdalin (laetrile) shall be maintained in a clean and or- derly manner and shall be of suitable design, size, construction, and location to facilitate cleaning, mai…

Production and control pro- cedures. (a) Production and control procedures shall include all reasonable precautions, including the following, to assure that the amygdalin (lae- trile) produced has the safety, identity, strength, quality, and purity it purports to possess: (1) Eac…

Components. (a) All compo- nents and other materials used in the manufac- ture, processing, and packaging of amygdalin (la- etrile), and materials necessary for building and equipment maintenance, upon receipt shall be stored and handled in a safe, sanitary, and order- ly manner.…

Product containers and their packaging materials. (a) Suitable specifications, test methods, cleaning procedures, and, when in- dicated, sterilization procedures shall be used to assure that containers, closures, and other com- ponent parts of packages are suitable for their inte…

Laboratory controls. (a) Lab- oratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, and test procedures to assure that com- ponents, in-processed drugs, and finished prod- ucts conform to appropriate standards of ident…

Stability. (a) There shall be as- surance of the stability of finished amygdalin (lae- trile) 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 ma…

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

Expiration dating. (a) To as- sure that amygdalin (laetrile) products liable to deterioration meet appropriate standards of iden- tity, strength, quality, and purity at the time of use, the label of all such products shall have suitable expiration dates which relate to stability …

Packaging and labeling. (a) Packaging and labeling operations shall be ade- quately controlled, to assure that only those prod- uctsthathavemetthestandardsandspecifications established in their master production and control records shall be distributed; to prevent mixups between …

Master production and con- trol records. (a) Batch production and control records. (1) To assure uniformity from batch to batch, a master production and control record for each drug product and each batch size of amyg- dalin(laetrile)shallbeprepared,dated,andsigned or initialed b…

Distribution records. (a) Fin- ished goods warehouse control and distribution procedures shall include a system by which the distribution of each lot of amygdalin (laetrile) can be readily determined to facilitate its recall if nec- essary. Records within the system shall contain…

Complaint files. Records shall be maintained of all written and oral complaints regarding each product. An investigation of each complaint shall be made. The record of each in- vestigation shall be maintained for at least two (2) years after distribution of the product has been c…

Reference laboratory con- trol. (a) Manufacturers of amygdalin (laetrile) shall submit to the state department of health and environmental laboratories, prior to re- lease of any lot number of amygdalin (laetrile) to wholesalers or physicians, 10 (ten) ampules or vials of injecta…

Special packaging require- ments. Each vial or ampule of injectable amyg- dalin and each vial or container of tablets or cap- sules shall contain a package insert with complete description of the product including potency, adverse reactions, contra-indications, dosage recommendat…

Registration and renewal of registration. (a) Any pharmaceutical firm de- siring to manufacture amygdalin (laetrile) in the state of Kansas shall file an application for a per- mit with the secretary of health and environment. Such application shall be accompanied by a fee of $2,…

Price and fee control. (a) The maximum reasonable price at which amygdalin (laetrile) may be sold to a pharmacist or direct to a physician licensed in the state of Kansas shall be based on cost of production for the product plus 25% (twenty-five percent). A cost of production ana…

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)

(Authorized by K.S.A. 1979 Supp. 65-663, 65-673; effective Jan. 1, 1966; revoked May 1, 1980.)

(Authorized by K.S.A. 1979 Supp. 65-663; effective May 1, 1980; revoked June 4, 2010.)