Board of Pharmacy Proposes Regulations to Add Self-Assessment Requirements for Third-Party Logistics Providers and Responsible Managers

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By Sarah Dahm

On September 17, 2021, the California Board of Pharmacy noticed its proposal to amend section 1784, Title 16 of the CCR to provide clarity with respect to whom the section applies, as third-party logistics providers (3PLs) perform similar functions as wholesalers and are required to comply with the same laws and regulations, so it is appropriate to include their reference in the form. The proposed amendments also identify the individual who must complete the self-assessment based on the license type: so a 3PL can only employ a responsible manager, and a wholesaler can only employ a designated representative-in-charge (DRIC).

The proposed text of the regulation, approved by the Board on November 9, 2017, would require a wholesaler licensed under the Business and Professions Code to complete a self-assessment once every two years or within 30 days of: (1) a new wholesaler license being issued; or (2) a change in the designated representative-in-charge (DRIC); or (3) a change in licensed location of a wholesaler to a new address.

In its initial statement of reasons, the Board stated that these changes will benefit the health and welfare of residents and will benefit employee safety. The Board also said that the regulation will ensure regulatory consistency between wholesalers and third-party logistics providers (3PLs). The self-assessment will identify any areas where wholesalers or 3PLs are out of compliance.

The initial statement of reasons also stated that the California Board of Pharmacy adopted a self-assessment process for a wholesaler to use for maintaining compliance with specific state and federal laws. The proposed regulation includes a requirement to complete the self-assessment, the frequency of completion of the assessment, and other general requirements. The proposal further updates the form to include law and regulations adopted since 2014, and exclude law and regulations that have been superseded or repealed since 2014.

In September of 2014, the Governor signed AB 2605 (Bonta) (Chapter 507, Statutes of 2014), which added the ability for a 3PL to gain a license from the Board of Pharmacy to provide or coordinate the warehousing of, or other logistics services for, a prescription drug or device on behalf of another person. The proposal at hand will address the new license category by requiring a self-assessment for 3PLs.

On September 17, 2021, the 45-day comment period for the Board’s proposed rulemaking action began. The proposal’s 45-day comment period ends on November 1, 2021.

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