The U.S. Food and Drug Administration (FDA) posted a "Notice" announcing a change in its procedure for inspections of certain human drug compounders; this change took effect on August 1, 2016. They stated the change is in response to stakeholder input.

The change includes the following:

• Investigators will make a preliminary assessment of whether the pharmacy is operating as a 503A pharmacy (a traditional pharmacy).
  
  
• If operating as a 503A pharmacy, the investigator will NOT include observations representing deviations solely on CGMP requirements.
  
  
• If NOT operating as a 503A pharmacy, then the investigator will apply CGMP requirements and list noncompliance observations on the '483.

Leading up to this action was stakeholder input that "they (the stakeholders) would like inspectional evidence regarding section 503A to be reviewed earlier, prior to the close of an inspection, and to be taken into consideration in decisions about what to include in any Form FDA-483."

The International Academy of Compounding Pharmacists (IACP), an organization all compounders should support, has specifically questioned why:

• Records of inspections ('483s) based on CGMPs were published to the FDA's website publicly for all to see even when FDA later determined the pharmacy was in compliance with section 503A and then handed the pharmacy investigation back to the State Board of Pharmacy, and
  
  
• The FDA would not always give pharmacies copies of the '483 when they were leaving the inspection.

Keep in mind that Section 503A was added to the FD&C Act by FDAMA1997 (Public Law 105-115) and describes the conditions that must be satisfied for drug products compounded by a licensed pharmacist or licensed physician to be exempt from three sections of the FD&C Act related to:

1. Current Good Manufacturing Practices
2. The labeling of drugs with adequate directions for use and
3. The approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Compounding enables physicians and pharmacists to provide important medications to patients without the requirements of meeting the above three activities.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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Did You Know ...

�that the FDA still continually reports on and brings to public attention the 2012 fungal meningitis outbreak involving contaminated injectable drug products today (four years later)?

Tip of the Week

With all the negative quality issues of drug products coming from FDA-inspected plants in other countries affecting potentially hundreds of thousands of patients, maybe their efforts should be redirected at manufacturers and not to compounders.

Looking Back

Use this cream
A day or two,
Then don't call her-
She'll call you!
     Burma Shave