In its recent guidance “Evaluation of Bulk Drug Substances Nominated for Use in Compounding” for outsourcing facilities, FDA again prioritized the use of FDA-approved drugs over more risky, custom-made medicines produced in bulk.

The guidance limits the raw substances that outsourcing facilities can use to make medicines in bulk that do not go through the FDA safety review process.

The FDA said it would only allow a raw substance to be used if a clinical need was established showing why an FDA-approved drug could not be used to make a compounded medication by, for example, diluting or crushing it.

To remind, FDA created a new category of compounders – outsourcing facility –  following the outbreak of fungal meningitis linked to tainted compounding in 2012. Outsourcing facilities can sell products in bulk without individual prescriptions while following federal drug manufacturing standards. Under the regulations, FDA was required to establish a list of substances outsourcing facilities could use for bulk compounding that met a “clinical need.” So far, FDA has not finalized the list, but under an interim policy, it allowed the use of substances that compounders could nominate for eventual inclusion on the list that had no major safety issues.

Under the guidance, FDA intends to maintain a current list of all bulk drug substances it has evaluated on its website, 238 with separate lists for bulk drug substances it has placed on the 503B Bulks List and those it has 239 decided not to place on the list. FDA again reminds that it will only place a bulk drug substance on the 503B Bulks 240 List where it has determined there is a clinical need for outsourcing facilities to compound drug 241 products using the bulk drug substance.

The guidance explains how FDA evaluates whether to include a specific substance on the list: