FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary

Adel H Karara

doi:10.1186/s41120-016-0007-0

Abstract

FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary

Highlights

The statement made by Debra Schotik Chan in 2001 (Chan 2001) regarding the regulations for use of bulk drugs in animals being unclear was probably true until last year
If the compounded drug is for a food-producing animal, it may pose a risk to the animals or humans if unsafe tissue residues should occur or it may be ineffective in the animal (Steinschneider 2012). For these products, there is no mandatory reporting to the FDA of adverse events drug experiences (Steinschneider 2012). These products may undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled (Guidance for Industry (Draft) (#230) 2015)
FDA does not intend to take action under sections 512(a), 501(a)(5), and 501(a)(2)(B) of the FD&C Act (FD&C Act Chapter V) if an outsourcing facility compounds animal drugs from bulk drug substances in accordance with the defined applicable conditions published in the document (Guidance for Industry (Draft) (#230) 2015)

Summary

Background

The statement made by Debra Schotik Chan in 2001 (Chan 2001) regarding the regulations for use of bulk drugs in animals being unclear was probably true until last year. If the compounded drug is for a food-producing animal, it may pose a risk to the animals or humans if unsafe tissue residues should occur or it may be ineffective in the animal (Steinschneider 2012) For these products, there is no mandatory reporting to the FDA of adverse events drug experiences (Steinschneider 2012). FDA does not intend to take action under sections 512(a), 501(a)(5), and 501(a)(2)(B) of the FD&C Act (FD&C Act Chapter V) if an outsourcing facility compounds animal drugs from bulk drug substances in accordance with the defined applicable conditions published in the document (Guidance for Industry (Draft) (#230) 2015). Key features of the conditions mandated by guidance include (Guidance for Industry (Draft) (#230) 2015): When finalized the document will be populated with a list of bulk drug substances (Appendix A of FDA guidance) for use by outsourcing facilities. The drug is not intended for use in food-producing animals and that it is compounded under cGMP

Providing FDA with biannual reports on outsourcing activities

Conclusions