Pharmacists cannot brew up large batches of unapproved drugs to sell, the government said Tuesday in new guidelines for specially mixed medications.
The new regulations are meant to replace rules struck down by the Supreme Court.
Pharmacists have long “compounded” drugs, altering or specially brewing a prescription medicine to fit a patient’s special needs instead of simply dispensing a drug made by a pharmaceutical company. Often, compounding merely means adding child-friendly flavorings to bad-tasting drugs, removing an allergy-causing ingredient or making a drug easier to swallow.
In recent years, though, some pharmacists have started selling large amounts of possibly dangerous home-brewed medications nationwide, the Food and Drug Administration (news – web sites) says.
The FDA sought to stem that trend by banning the marketing of compounded drugs. In April, however, the Supreme Court struck down the ban as a violation of free speech and directed the Bush administration to look at other options.
“We continue to be concerned about manufacturing in the guise of pharmaceutical compounding, and the Supreme Court accepted that as a compelling government interest,” FDA attorney David Horowitz said Tuesday.
Among the acts the FDA will consider in determining if compounding is really illegal drug manufacturing:
Compounding in anticipation of receiving prescriptions instead of after getting one, or for resale.
Compounding drugs that were banned for safety reasons, or that use experimental ingredients without FDA’s consent.
Using commercial-scale manufacturing or testing equipment during compounding, or using ingredients without assurance they were made in an FDA-registered facility.
Compounding copies of FDA-approved, commercially available drugs.