The pharmaceutical industry is trying to head off a congressional push to loosen regulations for compounding pharmacies, a cheaper competitor.
Several pharmaceutical trade groups and public advocacy groups Pew Charitable Trusts and Trust for America’s Health wrote to Senate leaders Wednesday to keep regulations for compounding pharmacies intact. The impetus was a provision tucked into a House appropriations bill that would loosen compounding regulations.
Compounding involves a pharmacist making a personalized drug for a patient. For instance, if a drug is not available in a certain dose then a compounder can make it in that dose based on the patient’s prescription.
The House provision would allow a pharmacist to make a small amount of a drug in preparation for getting a prescription from a doctor, a practice called “office use” compounding.
The bill, which cleared the House Appropriations Committee last week, would ensure that the practice remains.
A report on the bill said that a 2013 law to bolster federal authority over the pharmacies improperly restricted the practice.
The appropriations bill calls on the Food and Drug Administration to issue guidance on how compounding pharmacies can properly do “office use.”
Senate appropriators are now starting work on their own FDA funding bill.
So drug companies want the Senate to leave out the “office use” provision in any version of their bill.