Section 10377.5 - Requirements for the Establishment and Maintenance of Human Prescription Drug Records(a) Human prescription drug manufacturers shall establish and maintain inventories and records of all transactions regarding the disposal of human prescription drugs. These records shall include the following information: (1) The identity and quantity of the human prescription drugs disposed of; and(2) The dates of disposal of the human prescription drugs.(b) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), shall be made available for inspection and photocopying by the Department or any authorized federal, state, or local law enforcement agency officials for a period of at least three years following distribution, disposal, or other disposition.(c) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection as soon as possible, but no later than two working days after a request by an authorized official of a federal, state, or local law enforcement agency.(d) Human prescription drug manufacturers shall establish and maintain lists of officers, directors, managers, and other persons in charge of human prescription drug manufacturing, distribution, storage, and handling, including a description of their duties and a summary of their qualifications.Cal. Code Regs. Tit. 17, § 10377.5
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 A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.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 A Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language will be repealed by operation of law on the following day.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 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 subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).