FDA Spells Out Compounding Pharmacy Reporting and Registration Requirements
The FDA will require large compounding pharmacies to register each year, pay a $15,000 annual fee and report a detailed list of all the products they manufacture every six months.
The reporting and registration requirements were released in three guidances that offer new details on how large compounders can comply with the rules for outsourcing facilities, a voluntary regulatory category created in 2013 for compounders that operate more like traditional manufacturers.
One important new change tells compounders that they can de-register their facilities by withdrawing their registration.
In general, the guidances changed little since the previous drafts were published. The final guidances on registration and fees left in place a requirement that any compounder that registers must re-register each year between Oct. 1 and Dec. 31 and pay an annual base registration fee of $15,000. An additional $15,000 re-inspection fee will be levied if investigators find the facility doesn’t meet FDA regulations.
Registered outsourcing facilities must also submit a report twice a year (in June and December) on all drugs compounded at the facility.
The agency’s revised draft guidance on reporting made few changes to the requirements, but provided expanded definitions on what must be included in the reports. For instance, a drugmaker must submit the strength of the active ingredient per drug unit. The package description and number of individual units produced is defined as the smallest individual package such as a vial, syringe or bottle.
The guidances also mandate that outsourcing facilities must register and submit product reports in a structured product labeling (SPL) format through the agency’s electronic submission process. The agency will no longer accept email submissions. The agency pointed compounders to its website at www.fda.gov/edrls for additional information on creating and submitting SPLs.
The agency still needs to finalize a set of compounder-specific GMPs. For now compounders have been using a set of interim GMPs that mainly focus on aseptic processing practices.
So far, 51 compounders have registered as outsourcing facilities since the designation was created by the Drug Quality and Security Act in November of 2013 specifically for those compounders that want to create and ship drug products without a prescription. Smaller compounders that only respond to a physician’s prescription will stay regulated by states.
The agency has previously estimated there are at least 1,000 U.S. large compounders eligible for registration. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.