A Richfield pharmacist who "compounds" or mixes brand-name drugs with fillers to cut costs for his customers has been accused by state licensing regulators of adulterating drugs and violating federal Food and Drug Administration guidelines.
The state Division of Occupational and Professional Licensing has filed a petition against Myron Dee Abraham and his Richfield Pharmacy, accusing him of unprofessional conduct and requesting "an appropriate sanction" against his licenses.Compounding prescriptions is allowed with the prescribing physician's permission, according to state law. But Abraham compounded prescriptions for physicians who asked him not to, the petition said, which also violates FDA guidelines.
One physician told Abraham that "several patients had experienced loss of control after taking (Abraham's) formulated medications," the petition said.
In a phone interview, Abraham said there has been confusion about when the doctors did and didn't want him to compound medication. But he characterized the state's petition as "a bunch of misrepresentations."
The petition described Abraham's practice as pulverizing brand-name drugs into powder, which is then mixed with a filler and repackaged in capsules. But the state accused Abraham of lacking controls in the process and remanufacturing medication "in such a way as to not guarantee the therapeutic integrity of the drugs."
"I have never done that," Abraham countered.
Compounding is not a new pharmaceutical practice. It's how pharmacists, using a mortar and pestle, created all medications before the advent of large drug companies. It is allowed today under federal guidelines designed to prevent pharmacists from manufacturing "new" drugs without regulatory oversight.
But some compounding pharmacists who believe large drug manufacturers have diminished the profession into "counting, pouring, licking and sticking" have banded together to protect their "birthright," said Shelly Schluter, executive director of Patients and Professionals for Customized Care, a Houston-based advocacy group for compounding pharmacists.
The group was formed in response to 1992 FDA guidelines on compounding, which Schluter described as "very vague and leave too much up to the discretion of investigators." She noted the issue may be decided in court if the FDA continues its crackdown on compounders.
Abraham explained his motivation for compounding is cutting costs and providing a wider variety of medication for his rural clientele. He said many manufacturers charge the same price for a drug regardless of its strength. By taking the strongest form of a brand-name drug and compounding it into the prescribed dosage, Abraham said he can cut the cost of a prescription in half.
"I am willing to cut a deal with the state to keep my license," he said, "but the little guy will be hurt by this."