Title 16. Professional and Vocational Regulations

Division 17. California State Board of Pharmacy

Article 10. Dangerous Drug Distributors (Refs & Annos)

16 CCR § 1780

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(e) The following procedures must be followed for handling returned, damaged and outdated prescription drugs.

(1) Prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated shall be placed in a quarantine area and physically separated from other drugs until they are destroyed or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

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.

HISTORY

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).

Title 16. Professional and Vocational Regulations

Division 17. California State Board of Pharmacy

Article 10. Dangerous Drug Distributors (Refs & Annos)

16 CCR § 1781

§ 1781. Pharmacist or Designated Representative on Premises and In Control.

(a) A registered pharmacist, or a designated representative certified in accordance with Section 4053 of the Business and Professions Code, shall be present and in control of a manufacturer's or wholesaler's licensed premises during the conduct of business.

(b) A designated representative-3PL, qualified in accordance with Section 4053.1 of the Business and Professions Code, shall be present and in control of a third-party logistics provider's licensed premises during the conduct of business.

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4022.5, 4022.7, 4053, 4053.1, 4160 and 4161, Business and Professions Code.

HISTORY

1. Amendment filed 7-21-66; effective thirtieth day thereafter (Register 66, No. 23).

2. Amendment filed 6-24-71; effective thirtieth day thereafter (Register 71, No. 26).

3. Amendment filed 3-8-84; effective thirtieth day thereafter (Register 84, No. 10).

4. Change without regulatory effect amending section and Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).

5. Change without regulatory effect amending section filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).

6. Amendment of section heading, section and Note filed 2-22-2021; operative 4-1-2021 (Register 2021, No. 9).

Title 16. Professional and Vocational Regulations

Division 17. California State Board of Pharmacy

Article 10. Dangerous Drug Distributors (Refs & Annos)

16 CCR § 1782

§ 1782. Reporting Sales of Drugs Subject to Abuse.

Each manufacturer, wholesaler, and third-party logistics provider shall report to the Board or its designee, up to twelve (12) times a year, all sales of dangerous drugs subject to abuse as designated by the Board for reporting, in excess of amounts to be determined by the Board from time to time. Reports shall be made within thirty (30) days of the request in the form specified by the Board.

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4081, 4164, 4165 and 4332, Business and Professions Code.

HISTORY

1. New section filed 3-31-78 as an emergency; effective upon filing (Register 78, No. 13). For history of former Section 1782, see Register 71, No. 26.

2. Repealed by operation of Section 11422.1(c), Government Code (Register 78, No. 14).

3. New section filed 10-13-78; effective thirtieth day thereafter (Register 78, No. 41).

4. Amendment filed 3-8-84; effective thirtieth day thereafter (Register 84, No. 10).

5. Change without regulatory effect amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).

6. Amendment of section and Note filed 2-22-2021; operative 4-1-2021 (Register 2021, No. 9).

Title 16. Professional and Vocational Regulations

Division 17. California State Board of Pharmacy

Article 10. Dangerous Drug Distributors (Refs & Annos)

16 CCR § 1783

§ 1783. Manufacturer, Wholesaler, or Third-Party Logistics Provider Furnishing Drugs and Devices.

(a) A manufacturer, wholesaler, or third-party logistics provider shall furnish dangerous drugs or devices only to an authorized person; prior to furnishing dangerous drugs and devices to a person not known to the furnisher, the manufacturer, wholesaler, or third-party logistics provider shall contact the board or, if the person is licensed or registered by another government entity, that entity, to confirm the recipient is an authorized person.

(b) "Authorized person" means a person to whom the board has issued a permit which enables the permit holder to purchase dangerous drugs or devices for use within the scope of its permit. "Authorized person" also means any person in this state or in another jurisdiction within the United States to the extent such furnishing is authorized by the law of this state, any applicable federal law, and the law of the jurisdiction in which that person is located. The manufacturer, wholesaler, or third-party logistics provider furnishing to such person shall, prior to furnishing the dangerous drugs and devices, establish the intended recipient is legally authorized to receive the dangerous drugs or devices.

(c) Dangerous drugs or devices furnished by a manufacturer, wholesaler, or third-party logistics provider shall be delivered only to the premises listed on the permit; provided that a manufacturer, wholesaler, or third-party logistics provider may furnish drugs to an authorized person or an agent of that person at the premises of the manufacturer, wholesaler, or third-party logistics provider if (1) the identity and authorization of the recipient is properly established and (2) this method of receipt is employed only to meet the immediate needs of a particular patient of the authorized person. Dangerous drugs or devices may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt showing the type and quantity of the dangerous drugs or devices so received. Any discrepancy between the receipt and the type and quantity of dangerous drugs and devices actually received shall be reported to the delivering manufacturer, wholesaler, or third-party logistics provider by the next business day after the delivery to the pharmacy receiving area.

(d) A manufacturer, wholesaler, or third-party logistics provider shall not accept payment for or allow the use of an entity's credit to establish an account for the purchase of dangerous drugs or devices from any person other than: (1) the owner(s) of record, chief executive officer, or chief financial officer listed on the permit for the authorized person; and (2) on an account bearing the name of the permittee.

(e) All records of dangerous drugs or devices furnished by a manufacturer, wholesaler, or third-party logistics provider to an authorized person shall be preserved by the authorized person for at least three years from the date of making and shall, at all times during business hours, be open to inspection by authorized officers of the law at the licensed premises. The manufacturer, wholesaler, or third-party logistics provider shall also maintain all records of dangerous drugs or devices furnished pursuant to this section for at least three years from the date of making and shall, at all times during business hours, keep them open to inspection by authorized officers of the law at the premises from which the dangerous drugs or devices were furnished.

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4025, 4043, 4059, 4059.5, 4080, 4081, 4105, 4120, 4160, 4161, 4163, 4165 and 4304, Business and Professions Code; and Section 11209, Health and Safety Code.

HISTORY

1. New section filed 8-25-99; operative 9-24-99 (Register 99, No. 35). For prior history see Register 84, No. 10.

2. Amendment of section heading, section and Note filed 2-22-2021; operative 4-1-2021 (Register 2021, No. 9).