Actions Following the FDA Compounding Priorities Plan

The FDA stated in its Compounding Policy Priorities Plan:

These provisions [restriction on com- pounding essentially copies of commercially available drugs or approved drug products] of the law are an important mechanism to protect both public health and the premarket approval process...Our goal will be to make sure that patients do not receive compounded drugs unnecessarily when an FDA-approved drug is appropriate to meet their medical needs.

To this end, the FDA also released 2 final guidance documents related to compounding what it called “essentially copies” of commercially available drugs for 503A traditional compounders and 503B outsourcing facilities.

503A Traditional Compounding

The final guidance document related to 503A traditional compounders remained basically unchanged from the prior draft guidance. The final 503A guidance focuses on the following 3 items regarding whether a compounded drug product is “essentially a copy” of a commercially available drug product:
  • The compounded drug product has the same active pharmaceutical ingredient.
  • The active pharmaceutical ingredients have the same, similar, or easily substitutable strength.
  • The products can be used by the same route of administration.
Notably, the FDA does not consider any prescription that documents a “significant difference” to be essentially a copy. Separately, the FDA interprets “regularly or in inordinate amounts” to be 4 or fewer prescriptions of compounded drug products that may be deemed essentially copies in a calendar month.

Additionally, the FDA stated that it is considering the 503A guidance’s applicability to hospitals and health systems and will address the issue in a separate guidance or rulemaking. This has yet to be released, but it is something to look out for.

503B Outsourcing Facilities

Like the 503A guidance, the 503B-related guidance remained largely unchanged from the draft version. In the 503B guidance, the FDA uses the following factors to determine whether the compounded drug product is essentially a copy of an approved product:
  • Active ingredients
  • Route of administration
  • Dosage form
  • Dosage strength
  • Excipients
However, unlike the section 503A guidance, the section 503B copies guidance does not permit a prescriber- or practitioner-determined “significant difference” exception for compounded drug products from being classified as essentially a copy if there is not a difference in the compounded drug product and approved drug product based on the above factors. Further, the section 503B guidance does not provide exemptions from requirements that apply to drug manufacturers to outsourcing facilities when compounding drug products that are solely subject to an OTC monograph.

Solidify the FDA's Partnership With State Regulatory Authorities

The FDA has looked to solidify its partnership with states through a memorandum of understanding (MOU) policy that is applicable to 503A traditional compounders (but not applicable to 503B outsourcing facilities). The MOU seeks for states to partner with the FDA for the primary purpose of addressing compounded drug products that are dispensed and distributed interstate by 503A traditional compounders. A state that chooses to enter into the MOU with the FDA is responsible for investigating certain complaints related to compounded drug products from 503A traditional compounders and reporting these complaints to the FDA. Additionally, the state must report certain information regarding the interstate distribution of compounded drug products to the FDA.

The FDA made substantial revisions to the draft standard MOU released in 2015, including:
  • Revising the 30% threshold for a hard stop of interstate distribution of compounded products by 503A traditional compounders in favor of a more risk-based approach. Specifically, the new draft MOU requires states to agree to identify 503A compounders that distribute more than 50% of their total prescription orders for compounded drug products interstate and then report certain information to the FDA about those 503A compounders.
  • Revising the definition of distribution that exempts a patient physically picking up a prescription from the 503A traditional compounder facility, even if the patient does not reside in the same state as the facility.
Provide Guidance on Other Compounding Activities

In May, the FDA released a final guidance regarding an updated definition that addressed outsourcing facilities, revising prior policies related to:
  • Whether an outsourcing facility can be colocated with a 503A pharmacy
  • Whether an outsourcing facility can also manufacture FDA-approved drugs within the same facility
  • When compounded drug products intended to be produced under 503A would not also be held to 503B standards
The FDA released a revised draft guidance in September 2018 that described examples of conditions that the FDA considered to be unsanitary and in violation of the FD&C Act. The FDA also aimed to better define the circumstances under which it believed drugs were being mixed and applied in a manner that creates negligible patient risk and, therefore, would not be subject to the same compliance policy under the agency’s risk-based approach.


The FDA was very busy in the compounding space for all of 2018. The agency has taken numerous stakeholder comments into account and accordingly revised some of its previous policies related to compounding. Although the FDA may not make many 360° changes for the next 2 years, its focus on compounding activities under both 503A and 503B are unlikely to relent soon. For a current compounder or someone looking to enter the space, it is imperative that their business remains on top of the latest compounding developments.

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