The bill creates a new category of facilities into which compounders of sterile drugs can opt, called “outsourcing facilities.” Outsourcing facilities will be subject to FDA oversight similar to drug manufacturers, with the exception of being able to compound products without filing a new drug application.
An outsourcing facility is free to choose whether it will (i) be state licensed as a pharmacy or not; and (ii) obtain prescriptions for identified individual patients and/or prescribe for unlimited office use.
A potentially-critical prohibition, however, is applied to outsourcing facilities, in that will only be permitted to compound from bulk API, as opposed to commercially available drugs, that appear on an affirmative, finite list that will be established by HHS.
In addition, outsourcing facilities will be required to:
- register themselves and the products they compound with FDA.
- pay an establishment fee when the outsourcing facility registers with the FDA.
- The initial base registration fee is $15,000, subject to adjustment for inflation and small businesses.
- pay reinspection fees.
- label their products with a statement that identifies the drug as a compounded drug and other enumerated requirements including, the contact information of the outsourcing facility; the lot number; the date the drug was compounded and the expiration date; storage and handling instructions; a statement that the drug is “not for resale”; and a list of active and inactive ingredients.
- provide FDA with adverse event reports.
- have FDA conduct risk-based inspections.
- Inspection scheduled will be based on factors including the compliance history of the outsourcing facility; the record, history and nature of recalls linked to the outsourcing facility; and the inherent risk of the drugs compounded at the outsourcing facility.