As of April 11, 2014, the FDA has received and processed requests for 37 compounding pharmacies as outsourcing facilities. A complete list of registered facilities can be found here. For those of you that perhaps have not followed the compounding pharmacy issue lately, a registered outsourcing facility is described by FDA under the law:
Under section 503B, outsourcing facilities that compound human drugs may register and meet certain other requirements to qualify for the exemptions from the new drug approval requirements and the requirements for adequate directions for use. Under section 503B, an outsourcing facility is a facility that:
• Is engaged in the compounding of sterile drugs
• Has elected to register as an outsourcing facility
• Complies with all of the requirements of section 503B
• Is not required to be a licensed pharmacy, but compounding must be by or under the direct supervision of a licensed pharmacist
•May or may not obtain prescriptions for identified individual patients
When registering, an outsourcing facility must pay a fee. Registering as an outsourcer means that the compounding pharmacy will be inspected according to a risk-based schedule.
In October 2014, outsourcing facilities will be required to pay a fee. The fee schedule will be published in August 2014, and any facility that registers on or after fees are due will have to pay the registration fee at the time of registration.
One thing that registering does is open the outsourcing facility to FDA inspection. Quite interestingly, of the 37 outsourcing facilities currently registered, 22 have already received an FDA 483. So what are actual outsourcing facilities – they are actually quasi-manufacturing facilities that are being more closely regulated by the FDA. The creation of the “outsourcing facility” arose during the two year period after the New England Compounding Center fiasco that was linked to 44 deaths from a fungal meningitis outbreak. The statute that created this new outsourcing entity gives the FDA more clearcut responsibility for such facilities that are seeking an exemption from the new drug and labeling requirements of the Federal Food, Drug and Cosmetic Act. Time will tell whether these actions were sufficient to provide the necessary oversight to avoid another tragedy.
