AbsoluteRX stresses need for compound drug licensing
Recent incidents that question the integrity of compounded drugs emphasize the need for greater licensing and fraud control for all such companies, representatives for AbsoluteRX said.
AbsoluteRX said companies serving the U.S. market should only use chemicals approved by the FDA, employ Board Certified Pharmacists, work in an ISO Class-5 Clean Room and maintain USP 797 Compliance.
The need for tighter approval comes after cases such as Moses Lake compounded pharmacy in Washington, who in late July recalled unexpired human and veterinary compounded drugs due to concerns about their sterility.
“Many patients require medication that traditional pharmaceutical companies can't provide,” industry expert William Soliman said. “It could be a specific dose, dosage form, discontinued medications or a combination of medications not readily available.”
Some controversy continues over whether state pharmacy boards or the federal FDA should be the main regulator of compounding services, AbsoluteRX said. One reason for this controversy is the existing federal guidelines don't apply to veterinary medicine, or compounding done for veterinary purposes. Until FDA finalizes monitoring rules in this area, AbsoluteRX recommended consumers look to the companies that have as comprehensive a licensing approval history as possible before accepting their services.