FDA announces major change in pharmacy inspections

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Agency will determine if compounders are 503A facilities before applying CGMPs

Today, in response to the ongoing efforts of APhA and our members, FDA issued a notice announcing that it is changing its procedure for inspections of human drug compounders.

Starting August 1, FDA inspectors will make a preliminary assessment of whether pharmacies are in compliance with 503A before applying 503B standards in “Form FDA-483” investigations and will not include observations in its Form-483 based “solely” on FDA’s good manufacturing practice (CGMP) requirements under 503B, unless it appears that pharmacies are compounding drugs that do not qualify for the 503A exemptions.

FDA published the notice on its website.

Key facts:

  • The FDA notice is effective August 1 (and does not apply to current or past inspections).
  • Going forward, FDA will need inspectional evidence regarding section 503A to be reviewed, prior to the close of an inspection, and to be taken into consideration in decisions about what to include in any Form FDA-483.
  • FDA acknowledges that “because a Form FDA-483 does not represent a final Agency determination regarding a firm’s compliance, formerly, FDA investigators have been identifying deviations from drug production practices on Forms FDA-483 that could lead to quality problems without regard to whether the observations related to CGMP deficiencies or other deficiencies
  • FDA intends to continue to inspect compounding facilities and to take action, as appropriate, when the agency identifies violations of Federal law that could put patients at risk.

Troubling language remains in the notice:

  • FDA will still undertake inspections of 503A facilities, rather than complying with current statute.
  • FDA still intends to include CGMPs on Form FDA-483s, potentially for 503A pharmacies.
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