Regulatory Focus™ > News Articles > 2021 > 10 > FDA revises guidance on hospital, health system compounding

FDA revises guidance on hospital, health system compounding

Posted 06 October 2021 | By Michael Mezher 

FDA revises guidance on hospital, health system compounding

Five years after issuing draft guidance detailing its enforcement policy toward hospitals and health system pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act, the US Food and Drug Administration (FDA) has revised its approach to give more flexibility to hospitals and health systems and to address compounded drugs that are essentially copies of commercially available drugs.
 
"We understand that compounded drugs can serve an important role for patients in hospitals and other healthcare settings whose medical needs cannot be met by an FDA-approved product, and that hospital care raises unique considerations and needs," said Donald Ashley, director of the Office of Compliance within the Center for Drug Evaluation and Research (CDER).
 
While FDA's 2016 draft guidance offered some flexibility to hospitals and health systems to compound drugs in advance of receiving a patient-specific prescription, its limitation on distribution of such compounded drugs to a one-mile radius was a sticking point for hospital and health system stakeholders.
 
Ashley said that FDA received numerous comments on the one-mile radius provision, which prompted the agency to revisit its approach. "Stakeholders commented that the proposed one-mile policy was not reflective of the structure of health systems, many of which operate under a centralized compounding model and may serve facilities at other sites located outside a one-mile radius without similar compounding capabilities," he said.
 
Under the agency's new policy, 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 … when the practice is strictly limited and controlled," and the following criteria are met:
  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'; and
  3. The drug products are compounded in accordance with all other applicable requirements of the FD&C Act and FDA regulations.
FDA also laid out a risk-based approach to enforcement for hospitals and health systems that fail to operate within the limits laid out in the guidance. The agency will prioritize its compliance and enforcement resourced to go after sites with evidence of poor compounding practices or lack of sterility assurance, non-patient-specific compounded drug products that are not for emergency use, and sites that manufacture routine, large amounts of non-patient-specific compounded drugs. The agency will also target hospital and health system pharmacies that routinely distribute large amounts of non-patient-specific compounded drugs across state lines and that do not have procedures in place to obtain non-patient-specific drugs from a registered outsourcing facility.
 
Essentially copies
 
The revised draft guidance describes the agency's enforcement policy for hospital and health system compounding of drugs that are "essentially copies" under section 503A of the FD&C Act.
 
In the guidance, FDA writes that it will generally not take action against hospital or health system pharmacies that make such copies "regulatory or in inordinate amounts," as long as several criteria are met. In addition to administration of such products being restricted to patients within the hospital or health system, FDA said that pharmacies must obtain a statement from the prescriber 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."
 
Additionally, FDA writes that a statement should be on file for each prescriber that covers each compounded product and that the statement should be maintained in the hospital or health system pharmacy "to address routine orders for patients for whom the change produces a significant difference."


Statement, Federal Register Notice, Guidance

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe