In 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA, Public Law 112-144) into law. This Act has several important provisions that expand FDA’s authorities and strengthens the agency’s ability to advance and safeguard public health.

Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated and not acceptable for sale in the US any drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” (1)

On July 14, 2013, a draft guidance implementing penalties for manufacturers who delay inspections or deny access to inspectors was issued by FDA. (2)  The guidance defines the types of actions the FDA will consider to be “delaying, denying, or limiting inspection, or refusing to permit entry or inspection”.  These include:

  • Delay of inspections (i.e., delay scheduling pre-announced inspections, delay during an inspection and/or delay producing records);
  • Denial of inspection;
  • Limiting of inspection; (i.e., limiting access to facilities and/or manufacturing processes, limiting photography, limiting access to or copying of records, limiting or preventing collection of samples); and
  • Refusal to permit entry or inspection. (2)

An additional authority provided by FDASIA is section 709.  Section 709 amends section 304(g) of the FD&C Act (21 U.S.C. 334(g)) to provide FDA with administrative detention authority with respect to drugs. Section 304(g) of the FD&C Act, as amended by FDASIA, provides FDA the same authority to detain drugs that section 304(g) already provides FDA regarding tobacco products and devices.

Protecting the global drug supply chain and making sure that patients have access to the drugs they need is a priority for FDA.  As nearly 40% of finished drugs are imported and nearly 80% of active ingredients come from overseas sources,(3)it is important that FDA is provided the additional tools it has been seeking to better meet the challenges of regulating a global supply chain. FDASIA is an important regulatory development that enables FDA to better regulate the safety of the drug supply and to combat the trade of counterfeit and adulterated drugs.

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  1. Food and Drug Administration Safety and Innovation Act Section 707. Accessed 12 August 2013.
  2. Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. Accessed 12 August 2013.
  3. Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA. Accessed 12 August 2013.