New Drafted Guidance Issued by FDA Raises More Questions About Federal/State Licensing of Pharmaceuticals

The U.S. Food and Drug Administration recently released recommendations in question-and-answer format for the purposes of clarifying the Drug Quality Security Act. However, several contradictions in the state and federal licensing requirements from now until enactment and beyond (especially regarding California’s adopted licensing program), beg more questions.

The document titled “Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third- Party Logistics Provider Licensing Standards and Requirements: Questions and Answers, Guidance for Industry” the issue of state licensing is addressed in the following ways:

  1. Beginning on November 27, 2013, States are preempted from establishing or continuing any standards, requirements, or regulations with respect to 3PLs that are inconsistent with, less stringent than, directly related to, or covered by the standards or requirements applicable under section 584 of the FD&C Act. Thus, States may not impose standards, requirements, or regulations with respect to 3PLs that fall below the minimum standards established by Federal law.
  2. States can license 3PLs before the new Federal regulations issued according to section 584 become effective. The DSCSA contemplates that States can license 3PLs before the new Federal regulations become effective. For example, section 584(b) of the FD&C Act requires 3PLs to report “the State by which the facility is licensed” beginning one year after the date of enactment of the DSCSA.
  3. Once the new Federal licensing regulations for 3PLs become effective (see section 584(d)), States will be preempted from continuing or establishing licensure in any way that falls below the minimum standards established by those regulations. When the final regulations are published, States will know whether they need to change any standards, requirements, or regulations that they may have established that are inconsistent with, less stringent than, directly related to, or covered by those Federal regulations.
  4. Section 585(b)(2) does not permit states to license 3PLs as wholesale drug distributors. States would need to establish separate licensing programs for wholesale drug distributors and 3PLs.

The California Board of Pharmacy’s pharmaceutical licensing program specifically groups 3PLs and wholesale distributors. This bill, which was enacted a few weeks ago, is in direct opposition to the federal licensing standards. IWLA is preparing comments before the 60-day deadline about these contradictions. Stay tuned.

 

One response to “New Drafted Guidance Issued by FDA Raises More Questions About Federal/State Licensing of Pharmaceuticals

  1. Pingback: IWLA Representatives Attend California Board of Pharmacy Committee Meeting | iwla1891·

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