Some Republican lawmakers say pharmacists who make personalized preparations of drugs are being hurt by too much federal regulations installed after a deadly scandal a few years ago.
Sen. David Vitter, R-La., late last week introduced a bill seeking to stop federal regulations that the compounding pharmacy lobby says could derail shipment of vital drugs across state lines. If those regulations aren’t curbed, pharmacies complain, it will severely hinder their ability to get drugs to patients.
Compounding pharmacies make a personalized preparation of a drug. A pharmacist makes the preparation to a patient’s specific dosage and strength.
The industry came under heavy scrutiny in 2012, when the New England Compounding Center shipped allegedly tainted drugs all over the country. The products ended up infecting hundreds with fungal meningitis and killed more than 100 people.
The heads of the compounding pharmacy have been charged with murder.
In the wake of the outbreak, Congress passed the 2013 Drug Quality and Security Act. It set up a voluntary oversight process for larger compounding pharmacies that made a batch of drugs without a prescription.
The law also called for enhanced communication among states and the FDA, as miscommunication about who regulated the compounding center partially contributed to the quality breakdown. The compounding pharmacy also shipped its products across state lines with little to no oversight.
The agency released a proposed memorandum of understanding earlier this year that it seeks to give to states regarding compounding.
Compounders told the Washington Examiner on Monday the current proposal is overbearing and capricious.
If the states adopt the FDA’s proposed memorandum, they would require compounding pharmacies to send no more than 30 percent of compounded units to patients in other states.
However, the proposal doesn’t define exactly what “units” are, with some compounders saying it would be difficult to meet the requirement.
“That is a high hurdle for anyone in practice to figure out if you are in compliance with the law when you don’t know what the unit is,” said Gary McCrory, owner of McCrory’s Pharmacy in Texas. McCrory is the president-elect of the International Academy of Compounding Pharmacists, a trade group that held a briefing on the regulations on Monday.
It also would be hard for pharmacies on a state border to meet the cap as a lot of their business is along state lines, according to David Miller, CEO of the group.
He added that the 30 percent figure is not based on any scientific reason.
Lawmakers have hinted since the law’s passage that the FDA went overboard with its new authorities. One particular area of consternation is the practice of “office use.”
That is when a compounder is allowed to make a small batch of a drug that is used in a single doctor’s office. Under the law, the compounder would have to have a prescription for each single drug unit.
The practice is used for more common medications that are administered routinely in a doctor or even dentist’s office. An example given by McCrory was dentists’ use of the anesthetic lidocaine.
Lawmakers have said the 2013 law intended to exempt office use from being regulated. Last year Rep. H. Morgan Griffith, R-Va., wrote to the FDA asking about office use, which the agency replied it doesn’t believe is exempt.
Vitter’s bill, called the Saving Access to Compounding Medications for Special Needs Patients Act, would shield office use from regulation. It also would amend the FDA’s proposed memorandum of understanding to take out the 30 percent cap.
