Posted on October 06, 2021 | Through
Five years after issuing a draft guidance detailing its enforcement policy with respect to pharmaceutical composition of hospitals and the health system under section 503A of the Federal Law on Food, Drugs and Cosmetics, the US Food and Drug Administration (FDA) revised its approach to give hospitals and healthcare systems more flexibility and to deal with compound drugs that are essentially copies of commercially available drugs.
“We understand that compound drugs can play an important role for patients in hospitals and other healthcare facilities whose medical needs cannot be met by an FDA-approved product, and that hospital care raises concerns and concerns. unique needs, ”said Donald Ashley, director of the Office of Compliance at the Center for Drug Review and Research (CDER).
While the FDA’s 2016 draft guideline provided some flexibility for hospitals and health systems to prepare drugs before receiving a patient-specific prescription, its limitation on the distribution of these compound drugs within a one-mile radius. was a sticking point for hospital and health system stakeholders. .
Ashley said the FDA had received many comments on the mile radius provision, which prompted the agency to reconsider its approach. Stakeholders noted that the proposed one-mile policy does not reflect the structure of health systems, many of which operate under a centralized composition model and may serve facilities at other sites located outside a mile radius without similar composing capabilities, ”he said. noted.
Under the agency’s new policy, the FDA “generally does not intend to take any action regarding the Section 503A prescribing requirement of the FD&C Act if a hospital or pharmacy system is healthcare facility that is not an outsourcing facility prepares and dispenses a compound drug without receiving a valid prescription (including a record prescription) for an identified individual patient… when the practice is strictly limited and controlled ”and the following criteria are fulfilled:
- Compound drug products are only administered to patients within the hospital or healthcare system;
- Compound drug products are used or discarded within 24 hours of being transferred out of the pharmacy ”; and
- Pharmaceuticals are compounded in accordance with all other applicable requirements of the FD&C Act and FDA regulations.
The FDA has also defined a risk-based enforcement approach for hospitals and healthcare systems that do not operate within the limits set out in the guidelines. The agency will prioritize its compliance and enforcement of the necessary resources to tackle sites with evidence of poor preparation practices or lack of assurance of sterility, non-patient-specific compound pharmaceuticals that fail. are not intended for emergency use and sites that manufacture large quantities of patient-specific non-drug compound products. The agency will also target pharmacies in hospitals and health systems that routinely distribute large amounts of non-patient compound drugs across state lines and that do not have procedures in place to obtain non-patient drugs. specific to the patient with a registered outsourcing facility.
The revised draft guidelines outline the agency’s enforcement policy for the composition of hospitals and the health care system of drugs that are “essentially copies” under Section 503A of the FD&C Act.
In the guidelines, the FDA writes that it will generally take no action against hospital or health system pharmacies that make such “regulatory or inordinate” copies, as long as several criteria are met. In addition to limiting the administration of these products to patients within the hospital or healthcare system, the FDA has said pharmacies must obtain a prescriber statement that “specifies a change between the compound drug product and the product. commercially available medicament; indicates that the drug comprising the 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 target patient population for the compound drug product. “
Additionally, the FDA writes that a statement must be recorded for each prescriber that covers each compound product and that the statement must be kept in the hospital or health system pharmacy “to process routine patient orders for. which the change produces a significant difference “.
Declaration, Federal Register Notice, Advice
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