California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 10 - Dangerous Drub Distributors
Section 1780 - Minimum Standards for Wholesalers and Third-Party Logistics Providers
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
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.
(d) All materials must be examined upon receipt and before shipment.
(e) The following procedures must be followed for handling returned, damaged and outdated prescription drugs.
(f) Policies and procedures must be written and made available upon request by the board.
(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.
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.