Cal. Code Regs. Tit. 16, § 1780 - Minimum Standards for Wholesalers and Third-Party Logistics Providers

The following minimum standards shall apply to all wholesale and third-party logistics provider establishments for which permits have been issued by the Board:

(a) A wholesaler and a third-party logistics provider shall store dangerous drugs in a secured and lockable area.

(b) All wholesaler and third-party logistics provider premises, fixtures and equipment therein shall be maintained in a clean and orderly condition. Wholesale and third-party logistics provider premises shall be well ventilated, free from rodents and insects, and adequately lighted. Plumbing shall be in good repair. Temperature and humidity monitoring shall be conducted to assure compliance with the standards set forth in the latest edition of the United States Pharmacopeia.

(c) Entry into areas where prescription drugs are held shall be limited to authorized personnel.

(1) All facilities shall be equipped with an alarm system to detect entry after hours.

(2) All facilities shall be equipped with a security 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.

(3) The outside perimeter of the premises shall be well-lighted.

(d) All materials must be examined upon receipt and before shipment.

(1) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(2) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.

(e) The following procedures must be followed for handling returned, damaged and outdated prescription drugs.

(1) Prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated shall be placed in a quarantine area and physically separated from other drugs until they are destroyed or returned to their supplier.

(2) Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be placed in a quarantine area and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

(3) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality or purity, the drug shall be destroyed or returned to the supplier unless testing or other investigation proves that the drug meets the standards set forth in the latest edition of the United States Pharmacopeia.

(f) Policies and procedures must be written and made available upon request by the board.

(1) Each wholesaler and third-party logistics provider shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, for correcting all errors and inaccuracies in inventories, and for maintaining records to document proper storage.

(2) The records required by paragraph (1) shall be in accordance with Title 21, Code of Federal Regulations, Section 205.50(g). These records shall be maintained for three years after disposition of the drugs.

(3) Each wholesaler and third-party logistics provider shall establish and maintain lists of officers, directors, managers and other persons in charge of drug distribution, storage and handling, including a description of their duties and a summary of their qualifications.

(4) Each wholesaler and third-party logistics provider shall provide adequate training and experience to assure compliance with licensing requirements by all personnel.

(g) The board shall require an applicant for a licensed premise or for renewal of that license to certify under penalty of perjury that it meets the requirements of this section at the time of licensure or renewal.

Notes

Cal. Code Regs. Tit. 16, § 1780

1. New Article 10 (1780 through 1782) filed 9-14-60; designated effective 1-1-61 (Register 60, No. 20).
2. Amendment filed 7-21-66; effective thirtieth day thereafter (Register 66, No. 23).
3. New subsection (k) filed 6-24-71; effective thirtieth day thereafter (Register 71, No. 26).
4. Amendment filed 3-8-84; effective thirtieth day thereafter (Register 84, No. 10).
5. Amendment of subsection (b), new subsections (c)-(f), and amendment of NOTE filed 6-23-92; operative 7-22-92 (Register 92, No. 26).
6. Amendment of subsection (a) and new subsection (g) filed 5-20-96; operative 6-19-96 (Register 96, No. 21).
7. Change without regulatory effect filed 2-5-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 6).
8. Change without regulatory effect adding article 10 heading and amending NOTE filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
9. Amendment of article heading, section heading, section and NOTE filed 2-22-2021; operative 4-1-2021 (Register 2021, No. 9).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4025, 4043, 4045, 4051, 4053, 4053.1, 4054, 4059, 4120, 4160, 4161, 4161.5, 4304 and 4342, Business and Professions Code; Sections 109985 and 111280, Health and Safety Code; Section 321, Title 21, U.S. Code; and Section 205.50, Title 21, Code of Federal Regulations.

1. New Article 10 (1780 through 1782) filed 9-14-60; designated effective 1-1-61 (Register 60, No. 20).
2. Amendment filed 7-21-66; effective thirtieth day thereafter (Register 66, No. 23).
3. New subsection (k) filed 6-24-71; effective thirtieth day thereafter (Register 71, No. 26).
4. Amendment filed 3-8-84; effective thirtieth day thereafter (Register 84, No. 10).
5. Amendment of subsection (b), new subsections (c)-(f), and amendment of Note filed 6-23-92; operative 7-22-92 (Register 92, No. 26).
6. Amendment of subsection (a) and new subsection (g) filed 5-20-96; operative 6-19-96 (Register 96, No. 21).
7. Change without regulatory effect filed 2-5-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 6).
8. Change without regulatory effect adding article 10 heading and amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
9. Amendment of article heading, section heading, section and Note filed 2-22-2021; operative 4/1/2021 (Register 2021, No. 9).