Section 10377.8 - Manufacturers of Active Ingredient Components of Human Prescription Drugs(a) In addition to the regulations in this article, manufacturers of any active ingredient component of a human prescription drug shall comply with the following sections of Code of Federal Regulations, title 21, part 211 (revised as of April 1, 1992), except that all references to "drug product" shall apply to active ingredient components: sections 211.25 (Personnel qualifications), 211.28 (Personnel responsibilities), 211.42 (Design and construction features), 211.44 (Lighting), 211.46 (Ventilation, air filtration, air heating and cooling), 211.48(a) [first sentence] and (b) (Plumbing), 211.50 (Sewage and refuse), 211.52 (Washing and toilet facilities), 211.56 (Sanitation), 211.58(Maintenance), 211.63 (Equipment design, size, and location), 211.65 (Equipment construction), 211.67 (Equipment cleaning and maintenance), 211.68 (Automatic, mechanical, and electronic equipment), 211.142 (Warehousing procedures), 211.150 (Distribution procedures), 211.180(a), (c), (d), and (f) (General requirements), 211.182 (Equipment cleaning and use logs), 211.196 (Distribution records), 211.204 (Returned drug products), and 211.208 (Drug product salvaging).(b) In the event that it is impossible for a manufacturer of a biological drug to comply with both this section and the federal regulations for the manufacture of biologic drugs, this section shall not apply to the extent that it conflicts with a federal regulation specifically applicable to the biological drug product in question.Cal. Code Regs. Tit. 17, § 10377.8
1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.
3. Editorial correction of HISTORY 2. (Register 93, No. 20).
4. Certificate of Compliance as to 1-20-93 order including amendment of newly designated subsection (a) and new subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28). Note: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.
1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.
3. Editorial correction of History 2. (Register 93, No. 20).
4. Certificate of Compliance as to 1-20-93 order including amendment of newly designated subsection (a) and new subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).