Section 10377.4 - Requirements for the Storage and Handling of Human Prescription Drugs(a) All facilities at which human prescription manufacturers manufacture, store, warehouse, handle, offer, market, display, or otherwise hold human prescription drugs shall be secure from unauthorized entry and shall have adequate security conditions, as follows: (1) Access from outside the premises shall be kept to a minimum and be well-controlled;(2) The outside perimeter of the premises shall be well-lighted; and(3) Entry into areas where human prescription drugs are held shall be limited to authorized personnel.(b) All such facilities shall be equipped with an alarm system to detect entry after hours.(c) All such facilities shall be equipped with an alarm system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.(d) Each outgoing shipment of human prescription drugs shall be carefully inspected for identity of the human prescription drugs and to ensure that there is no delivery of human prescription drugs that have been damaged in storage or held under improper conditions. Records of nonconforming drugs and their disposition shall be established and maintained, and shall include the name and label potency of the drug product, dosage form, lot number, quantity, reason for nonconformance, name of the inspector, date of inspection, and disposition.(e) Human prescription drugs manufactured by the licensee, which are outdated, damaged, deteriorated, misbranded, or adulterated, shall be quarantined and physically separated from other prescription drugs until they are destroyed or brought into compliance with all applicable laws by reprocessing or relabeling. Records of drugs quarantined shall be established and maintained, and shall include the name and label potency of the quarantined drug product, dosage form, lot number, reason for the quarantine, name of the person responsible for the quarantine, location of quarantined drug product, date of disposition, and ultimate disposition of the quarantined drug product.Cal. Code Regs. Tit. 17, § 10377.4
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 A Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language will be repealed by operation of law on the following day.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 (a) 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 (a) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).