FDA Revisions Affect 503A and 503B Compounders

The FDA recently released the September 2018 revision to its Insanitary Conditions at Compounding Facilities guidance.

It includes changes that affect both 503A and 503B compounding facilities. One notable modification begins at line 104 in the document:

Note that the examples of insanitary conditions described in this guidance for products intended to be sterile can exist in cleanroom and associated controlled environments, as well as segregated compounding areas (SCAs), as described in United States Pharmacopeia (USP) Chapter <797> (USP <797>). However, when a compounding facility other than an outsourcing facility produces drugs in a SCA, FDA generally does not intend to take action with respect to certain conditions described in this guidance identified with an asterisk (*), provided that the compounding facility: (1) complies with all criteria for an SCA in USP <797>; (2) assigns beyond-use-dates that do not exceed 12 hours when stored at room temperature and 24 hours when refrigerated or frozen; and (3) does not have any additional insanitary conditions.

It is important that everyone who compounds pharmaceuticals read this document. Understanding of these changes will lead to continued product and patient safety.