On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health systems that compound drugs for patients within their facilities before receiving patient-specific prescriptions.
Most notably, the Draft Guidance removes the “one-mile radius” provision (as previously discussed in our 2016 article) that would have limited the ability of hospitals and health systems with centralized compounding operations to serve facilities beyond that limited distance. The Draft Guidance also outlines a two-part, risk-based compliance policy describing circumstances under which the FDA generally does not intend to enforce Section 503A against a hospital or health system pharmacy compounding a human drug without first receiving a valid prescription or order for an individual patient. Finally, the Draft Guidance proposes to establish limited circumstances under which the FDA does not intend to enforce Section 503A restrictions on compounding copies of commercially available drugs regularly or in inordinate amounts.
Note that since it is in draft format, the guidance is not formally binding on the agency. We recommend that pharmacies, hospitals, health systems, outsourcing facilities and other interested entities respond to the FDA’s request for comments and suggestions on the draft guidance and either request clarifications, offer support or recommend changes. Any comments to the Draft Guidance are due December 6, 2021.
The Draft Guidance addresses two key requirements under Section 503A of the Act. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient (section 503A(a) of the Act of the “Prescription Requirement”). Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D) of the Act or the “Essentially a Copy Requirement”).
The Prescription Requirement
As noted in our 2016 article, a drug may be compounded by a licensed pharmacy or physician based on the receipt of a valid prescription order for an identified individual patient. Recognizing that hospital and health system pharmacies sometimes compound drug products for use within the hospital or health system before the receipt of a patient-specific prescription, the FDA is proposing a two-part, risk-based approach to enforcement actions for technical violations of the Prescription Requirement. Under the first prong (“Part I”), FDA does not intend to take action with respect to the Prescription Requirement if a hospital or health system pharmacy that is not a 503B outsourcing facility produces a compounded drug product without first receiving a valid prescription order (including a chart order) for an identified individual patient when the following circumstances are present:
- The compounded drug products are administered only to patients within the hospital or health system.
- The compounded drug products are used or discarded within 24 hours of transfer out of the pharmacy.
- The drug products are compounded in accordance with all other applicable requirements of the Act and FDA regulations (e.g., the drug products are not made under insanitary conditions or misbranded.
In the absence of these Part I circumstances, the FDA intends to prioritize enforcement actions regarding the Prescription Requirement based on the potential for harm to the public health and to the integrity of the drug approval system. In doing so, the FDA would use the second prong of the risk-based approach (Part II) to assess the risks attributable to the following considerations:
- 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.
Where possible, though, the FDA indicated hospitals and health systems should first look to outsourcing facilities, or register their pharmacies as outsourcing facilities, to obtain non‑patient-specific compounded drug products.
The Essentially a Copy Requirement
The Act also describes circumstances in which a drug product may be compounded by a licensed pharmacist or licensed physician under 503A. One circumstance includes when the licensed pharmacist or licensed physician does not compound regularly or in inordinate amounts drugs that are essentially copies of a commercially available drug product. See 503A(b)(1)(D). As FDA described in greater detail in its 503A Copies Guidance, a drug is not “essentially a copy of a commercially available drug product” if there is a change made for an identified individual patient which produces for that patient a significant difference between the compounded drug and the comparable commercially available drug product.
Under the Draft Guidance, FDA states that it does not intend to take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product that is essentially a copy of a commercially available drug product when the following circumstances are present:
- The compounded drug product is administered only to patients within the hospital or health system.
- The pharmacy obtains from the prescriber a statement that: specifies a change between the compounded drug product and the commercially available drug product; indicates that the compounded drug product will be administered only to patients for whom the change produces a significant difference from the commercially available drug product; and describes the intended patient population for the compounded drug product.
- A statement is on file for each prescriber that covers each drug product that is compounded.
- The statement is maintained in the hospital or health system pharmacy to address routine orders for patients for whom the change produces a significant difference.
Although not yet finalized, the Draft Guidance signifies a shift in FDA’s thinking and willingness to permit expanded health system compounding. Importantly, the Draft Guidance allows hospital and health system pharmacies that are not outsourcing facilities to deliver compounded drug products to any other health care facility in the same system prior to receiving a valid prescription order for an individual patient. FDA’s earlier 2016 guidance limited this exception to facilities within a one-mile radius of the hospital or health system pharmacy. If adopted in its current form, this revised guidance would have meaningful implications for many hospitals and health systems, as many of them operate centralized compounding models and service facilities at other sites located outside a one-mile radius. Be aware that, although the one-mile radius requirement would be eliminated under the revised Draft Guidance, a new standard that compounded drugs be used or discarded within 24 hours of transfer out of the pharmacy could significantly impact hospital and health system operations. However, since the guidance is not final, pharmacies, hospitals, health systems and outsourcing facilities, should respond to the FDA’s request for input on the draft guidance by December 6, 2021.