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Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, March 11, 2021
Compounding Activities | COVID-19--guidance from the FDA
FDA is working to provide guidance to states and compounders on issues associated with compounding drugs during the COVID-19 pandemic. The agency’s guidance aims to protect patients from unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.
Outsourcing Facility Product Reports for Hospitalized Patients with COVID-19
The agency issued a guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency. Hospitals that cannot obtain FDA-approved drugs covered by the guidance and seek to use compounded drugs for their patients should first contact outsourcing facilities, which produce compounded drugs under more robust quality standards than those made by state-licensed pharmacies or federal facilities not registered as outsourcing facilities. Hospitals can use the product report to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.
The agency’s draft hospital and health systems guidance, which includes the “one mile radius” provision, is still in draft and we are planning to issue a revision. This draft guidance was issued for public comment and has not been implemented.
Although federal law specifies a 5 percent limit on distribution out of state of drugs compounded by pharmacies and physicians regulated under section 503A of the Federal Food, Drug and Cosmetic Act, the agency does not intend to enforce the 5 percent limit until after the agency has finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it.
The agency does not consider drugs that are on FDA’s shortage list or that have been discontinued and are no longer marketed to be “commercially available” under the “essentially a copy” provision for pharmacy and physician compounders regulated under section 503A of the FD&C Act.
The agency does not consider a compounded drug produced by an outsourcing facility to be “essentially a copy” if it is identical or nearly identical to an FDA-approved drug that is on FDA’s drug shortage list. The agency also does not intend to take action under this provision if the facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.
Specific Compounded Drug Concerns Related to COVID-19
Compounded drugs are not FDA-approved. This means they have not undergone premarket review for safety, effectiveness or manufacturing quality. Because they are subject to a lower regulatory standard, compounded drugs should only be used to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug. The agency recommends FDA-approved drugs be used to treat patients whenever possible. FDA has concerns about the use of certain drugs prepared by compounders to treat patients with COVID-19:
Thymosin-alpha 1 is not a component of an approved drug, and thymosin does not meet the conditions for compounding under sections 503A and 503B of the FD&C Act. FDA will take appropriate action against compounders that produce thymosin. The agency is aware of drug products containing thymosin being offered to patients for the treatment of COVID-19. However, thymosin is not approved to treat any condition, including COVID-19.
FDA recommends that the FDA-approved drug Veklury (remdesivir) be used to treat patients who are prescribed remdesivir. FDA is concerned that complexities related to the quality and sourcing of the remdesivir active pharmaceutical ingredient (API) and formulation of remdesivir drug products may make these drugs particularly challenging to compound. The agency is concerned patients may receive substandard or low-quality compounded remdesivir drugs which could result in patient harm.
FDA is responding to stakeholder inquiries on issues associated with compounding drugs during the COVID-19 emergency. Contact firstname.lastname@example.org with any questions.