Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).  The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document.  The revised document describes how and when the FDA will exercise enforcement discretion relative to the requirement that section 503A compounders must obtain prescriptions for specified patients prior to their compounding of products, and how and when the Agency may take enforcement action for the compounding of products by 503A compounders relative to the compounding of copies of versions of approved drug products.  The Agency also describes the risk-based enforcement decisions that it will take in an effort to better protect the integrity of the drug approval process.

There is obviously a need for patient-specific compounding by 503A compounders in hospitals and health facilities based on specific prescriptions or health chart orders for products that may need to be different from FDA‑approved versions of the drugs.  And while some 503A compounders in hospitals and healthcare facilities may compound a small quantity of a drug product in advance of receipt of a patient‑specific prescription, the FDA recommends that, if there is a continuing need to compound in advance for potential use for non-specified patients, that the hospital or healthcare system contract with a registered 503B outsourcing compounding facility to meet those needs and to best protect the patients under their care.  Or, if they intend on continuing the practice on a larger scale, that they register as a 503B compounder to best protect their patients.

In the draft document, the FDA describes its view on how to apply the enforcement policy to the patient‑specific prescription requirement for hospitals and health systems that operate as 503A compounders:

“FDA generally does not intend to take action with respect to the prescription requirement in section 503A of the FD&C Act if a hospital or health system pharmacy that is not an outsourcing facility compounds and distributes a compounded drug product without first receiving a valid prescription order (including a chart order) for an identified individual patient (see section 503A(a) of the FD&C Act) when the practice is strictly limited and controlled and the following circumstances are present:

  1. The compounded drug products are administered only to patients within the hospital or health system.
  2. The compounded drug products are used or discarded within 24 hours of transfer out of the pharmacy.
  3. The drug products are compounded in accordance with all other applicable requirements of the FD&C Act and FDA regulations (e.g., the drug products are not made under insanitary conditions (section 501(a)(2)(A)) or misbranded (e.g., section 502(g)).”

The Agency also plans to employ these risk-based considerations and factors in making specific enforcement decisions:

  • Evidence of poor compounding practices or lack of sterility assurance
  • Non-patient-specific compounded drug products not for emergency uses
  • Routine, large amounts of non-patient-specific compounded drug products
  • Routine interstate distribution of large amounts of non-patient-specific compounded drug products
  • No procedures to obtain non-patient-specific compounded drug products from an outsourcing facility

The document further describes the Agency’s current thinking on the criteria it will use to evaluate whether a compounded product is a duplicate of an approved product and what record keeping requirements will be required.  “In addition, the revised draft guidance proposes new policies for hospital and health system pharmacies regarding the provision in section 503A of the FD&C Act, which states that to qualify for the exemptions under section 503A of the FD&C Act, among other conditions, a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product.”

Section 503A compounders should take note of the Agency’s revised stance on the issues presented in the guidance and adjust their practices to ensure compliance with current Agency thinking, even though the guidance is still in draft form.