California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10386 - Manufacturer of Finished Dosage Form

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The 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.
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.