Though technically nonbinding on FDA and industry, the guidances are intended to facilitate FDA’s implementation of the DQSA, while providing additional insight into FDA’s regulatory approach for compounding facilities. Drug compounders will review the draft guidances and evaluate their operations to determine the scope of applicable regulatory requirements. Comments are due to FDA by Feb. 3, 2014, and input on the appropriateness of compounding certain substances/drugs are due March 4, 2014.
Detailed information about the three draft guidances is below:
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) (see here) Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FDCA (see here) Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FDCA (see here)
Outlines FDA’s intentions regarding enforcement of section 503A of the FDCA against entities that compound drugs.
Describes some of the possible enforcement actions FDA may bring against individuals/firms that compound drugs in violation of the FDCA.
Notes that the draft guidance does not apply to registered outsourcing facilities.
Applies to outsourcing facilities that compound human drugs.
Outsourcing facilities that compound sterile drugs may elect to register with FDA.
Focuses on electronic submission of establishment registration information.
Applies to outsourcing facilities that compound human drugs who must report information to FDA about the drugs compounded at the outsourcing facility.
Focuses on electronic submission of drug reporting information.
Requires compounders to submit a list of all drugs compounded during a six-month period and include information such as: active ingredients, number of units produced, dosage form and the National Drug Code number of the source drug.