Compounded drugs can serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as patients who have an allergy and need a medication to be made without a certain dye or hospital inpatients who need infusions of a drug combined with a particular diluent.

However, compounded drugs present a greater risk to patients than FDA-approved drugs. For example, compounded drugs are not evaluated by the FDA for safety, effectiveness, and quality before they are marketed, and poor quality compounded drugs have led to serious harm. In 2012, a fungal meningitis outbreak linked to contaminated steroid injections compounded by the New England Compounding Center, which were typically being administered in an office or clinic setting to treat back and joint pain, led to more than 60 deaths and 750 cases of infection.

As a result, the Drug Quality and Security Act was passed. This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created Section 503B. This section creates a new category of compounders, outsourcing facilities, and grants the FDA the authority to regulate facilities that voluntarily register as such. Drugs compounded by outsourcing facilities in accordance with the conditions of section 503B are eligible for exemptions from new drug approval requirements, labeling with adequate directions for use, and the supply chain security requirements. However, unlike other "traditional" compounders, outsourcing facilities must adhere to current good manufacturing practice.

Section 503B places conditions on compounding by outsourcing facilities. One of these conditions is that outsourcing facilities can only compound using bulk drug substances if:

  1. the substance appears on a list developed by the FDA of bulk drug substances for which there is a clinical need ("bulks list"), or
  2. the substance is used to compound a drug on the FDA's drug shortage list at the time of compounding, distribution, and dispensing.

The FDA has issued draft guidance that describes the factors that it is proposing to consider when determining whether to place a bulk drug substance on the bulks list. One of these factors involves assessing the current and historical use of the bulk drug substance in compounding.

More information is available on FDA's website.