Section 10386 - Manufacturer of Finished Dosage FormThe intent of this section is to assure that the advertising and labeling required by Section 26636(c) of the code provides sufficient useful information to pharmacists, physicians, and other purchasers of prescription drugs that they may identify certain persons participating in the manufacturing of the finished dosage form of such drug(s). These regulations are in addition to the regulations of other sections of the Sherman Food, Drug, and Cosmetic Law regarding labeling and advertising requirements for drugs.
(a) For the purpose of this section the finished dosage form of a prescription drug is defined as that form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling.(b) For the purpose of this section only, the term "drug" shall include only those articles as defined in Section 26010 of the Act which achieve their principal intended purposes through chemical action within or on the body of man or other animals or which are metabolized in the achievement of these purposes.(c) For the purpose of this section the term "manufacturer" means persons who "manufacture" as that term is defined by Section 26019 of the Health and Safety Code.(d) For the purpose of this section the term advertisement shall have the same definition as Section 26002 of the Health and Safety Code.(e) The labeling and advertising for any prescription drug, including those whose label states "distributed by ..." or similar language, must contain the name and place of business of the manufacturer who mixed the final ingredients, and the manufacturer who encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form, qualified by such phrases as "final ingredients mixed by ...," "encapsulated by ...," "tableted by ...," or words of similar or like meaning that express the facts. The presence of the name and address of only one manufacturer shall mean that only the named firm mixed the final ingredients and encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form.(f) The requirement for declaration of the name of the manufacturer of the finished dosage form shall be deemed to be satisfied in the case of a corporation only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.(g) For the purposes of this section, all products subject to this section will be deemed to be misbranded if the name and place of business of each manufacturer as described in the foregoing subsections of this regulation is not included in the labeling on, or within the package from which the drug is dispensed and in all advertising of such product intended primarily for dissemination to California practitioners.Cal. Code Regs. Tit. 17, § 10386
1. New section filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).
2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51). Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26636, Health and Safety Code.
1. New section filed 6-28-73; effective thirtieth day thereafter (Register 73, No. 26).
2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).