Changes Sought in 2 Compounding Guidances
The Biotechnology Innovation Organization (BIO) says in comments on two draft FDA guidances on compounded drug products that it has long supported a prohibition on compounding of commercially available FDA-approved products unless the drugs are medically necessary to address a unique individual patient need not met by the approved drug and supported by a valid prescription. The group says it is pleased that the agency incorporated that concept in the guidances.
BIO says it is concerned that the definition of “essentially a copy of an approved drug” that is in the 503B guidance is inconsistent with the definition of “essentially a copy of a commercially available drug product.” It cautions that the definition for 503B outsourcing facilities “could lead to large volume production of compounded drugs with slight alterations in strength and/or concentration without the necessary confirmation of clinical safety and effectiveness. This would essentially bypass the regulatory approval system and produce an unapproved drug under the guise of compounding.”
In its comments, the Pew Charitable Trusts discusses the importance of the FDA drug approval process, saying it is critical to protecting patient safety. Compounding copies of approved drugs is only appropriate when the drug is in shortage, or when a modification to the approved product is necessary to meet a patient’s unique clinical needs, the group says. Pew raises questions about the definition of “essentially copies.”
The American Society of Healthcare Pharmacists writes that although it supports FDA’s work, there are potential issues with interpretation and application of some guidance provisions, especially the scope of the drug shortages provision, the definition of bulk drug substances to include approved drugs, and the documentation requirements.
Finally, Public Citizen says it generally supports the policies expressed in the draft guidances. It says that stringent limits on compounding of drug products that are essentially copies of approved drugs under section 503B are critically important to protecting public health for the reasons outlined by FDA in the draft guidance. It also offers comments on several specific provisions.