Senate Proposes Draft for Stricter Compounding Legislation

On April 26th, the Senate introduced a draft legislation that would give the FDA greater authority over compounding pharmacies.  The hope is to eliminate future occurrences of tragic outbreaks like the NECC meningitis events.  The legislation clearly distinguishes between compounding pharmacies and compounding manufacturers.  It also proposes a uniform set of rules for compounding manufacturers while preserving the states' role in traditional pharmacy regulation.  It defines compounding manufacturers as "entities that compound sterile drugs without patient-specific prescriptions and sell the drugs across state lines."  They are differentiating between compounding pharmacies which have that base their products on prescriptions for individual patients.  It further states taht compounding manufacturers are "any entity that pools steril products or repackages sterile, single-use, preservative-free vials."
Compounded drugs will now be considered new drugs that are subject to the Food, Drug, and Cosmetic Act.  Compounders will not be able to compound complex dosages or biologic products.  They also will not be allowed to compound variations of marketed FDA-approved drugs unless the products fulfill a specific patient need or drug shortages occur.  Compounding manufacturers will now be required to register with the FDA and inform them of what products they have made and only compound drugs under a direct pharmacist's oversight.  They also have to comply with current GMPs and label their products appropriately.  Also, only the compounding manufacturer that produced the product will be able to sell that product.
All licensing will still be done by each state, but the bill proposes for more communication between states.  All these changes are in hopes of protecting patients.  That is who we as pharmacists should be the most concerned about and as such, I agree with this new proposed legislation.