FDA Strongly Opposes Compounding Drugs for Financial Reasons
​​[Posted on: Thursday, March 29, 2018]

In its latest Guidance Document and announcement for the current policy for compounding pharmacies, FDA emphasizes that the law supports only compounding drugs for which there is a clearly defined “clinical need” and not where compounded versions of approved drugs are created to make cheaper treatments for patients. The policy specifically applies to the 503B compounding pharmacies that are allowed to compounds active pharmaceutical ingredients (API), also called “bulk drug substances”. Since early 2017, FDA has maintained a list of about 200 APIs that are allowed to be compounded and about 850 APIs that are not allowed to be compounded. FDA’s current policy is to update the list of APIs based on the principle of “Clinical Need” which is defined as cases where either a similar FDA approved formulation does not exist or the FDA approved formulation contains ingredients that make it hard for certain patients to consume it. Compounded drug products should only be used by patients whose medical needs cannot be met by an FDA-approved drug. For example, an FDA approved formulation may not be appropriate for the route of administration needed for certain patients, or may contain inactive ingredient(s) that cause allergic responses in certain patients making it necessary to compound such drugs without the offending ingredients for such patients. However, the FDA policy clearly forbids compounding a drug product from an API when there is no clinical need to do so but may be compounded for economic reasons. The allowed compounded formulations are those of a needed concentration, route of administration or dosage form rather than simply diluting or otherwise manipulating the approved drug. Those formulations should be developed via the 505(b)(2) route and not compounded. For any API to be placed on the list of substances allowed to be compounded, FDA will review the clinical need strictly based on the above criteria. In addition for all substances included in the list of allowed substances, FDA would consider the available information on the physical and chemical characterization of the API, any safety and efficacy information, and history of clinical use to include or exclude a given substance from the list of substances allowed to be compounded. The list will be updated on an ongoing basis indicating that new API can be added and existing ones excludes based on new evidence presented to FDA. In the past, some compounding pharmacies have tried to use loopholes to created compounded copies of FDA-approved drugs; the new guidance is the most direct announcement by FDA against such practices.