It is important to ensure that the production of drugs in pharmacy compounding does not undermine the incentives to develop and submit new drug applications to FDA with evidence of the safety and efficacy. At the same time, we recognize that pharmacy compounding is necessary where there is a medical need of a particular patient for a product that is not commercially available in an approved form. We must exercise our regulatory authority in such a way as to support pharmacy compounding that is necessary, while curbing abuses.
quoted from Dr. Janet Woodcock testimony in 2003 found here
Recognizing the history of compounding practice, FDA supports the long-standing policy that all compounding should be performed in a licensed pharmacy by a licensed pharmacist (or a licensed physician), and that there must be a medical need for the compounded drug.
quoted from Dr. Janet Woodcock testimony in 2013 found here
No comments:
Post a Comment