FDA Outlines Enforcement Actions for Compounders

Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to.

Compounders have told the FDA in their responses that they believe they are instead subject to oversight of their State Pharmacy Boards, not the FDA.

In general, compounded drugs are exempt from GMP requirements if the products are for a specific patient with a prescription, or are produced in limited quantities by a pharmacist. Compounders are allowed to distribute 5 percent of their prescription orders to other states, but must enter into agreements with the FDA to distribute larger quantities. The FDA issued guidance in August on when to register with the agency as a compounder.

The FDA’s final guidance puts compounders on equal GMP footing with other drugmakers. The FDA says it does not need to identify a particular safety problem before pursuing an enforcement action.

The agency also published two draft guidances — covering the interim regulatory policy on compounding bulk drug substances, which is restricted under Section 503A, and compounding by outsourcing facilities, which is restricted under Section 503B of the FD&C Act.

SSM Health Care Warning Letter

Just one day after issuing its guidance on enforcement actions for compounders, the FDA issued a warning letter to SSM Health Care, which operates 19 hospitals across four states in the Midwest.

The letter cited GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at the company’s Fenton, Mo., facility.

An Aug. 4 to Aug. 14, 2014, inspection of the Fenton facility found that drug products intended to be sterile were prepared, packed or held under insanitary conditions. In one example, an operator was observed dropping an IV bag on the floor and using it.

The firm, which also operates in Illinois, Wisconsin and Oklahoma, failed to meet the necessary conditions to qualify for exemptions under Section 503B for drugs produced by an outsourcing facility.

As such, the FDA cited the firm for failing to meet 503B conditions, including failure to include on the label the dosage form, the date the drug was compounded and storage and handling instructions; failure to list active and inactive ingredients; and an absence of adverse event reporting information on the container.

GMP violations outlined in the warning letter included: manufacturing personnel not wearing appropriate clothing to prevent contamination, failure to establish and follow appropriate written procedures, failure to establish an adequate system for monitoring environmental conditions, failure to prepare complete batch production and control records and failure to thoroughly investigate failure of a batch.

The Oct. 19 letter also dings the firm for misbranded drug products. Since the compounded drug products are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, the directions cannot be written so that a layman can use the products safely, according to the letter.

SSM Healthcare declined to comment for this story.

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