Alarm over a fungal meningitis outbreak blamed on contaminated epidural methylprednisolone injections produced by the New England Compounding Center grew, brought understandable calls for having the U.S. Food and Drug Administration regulate drug compounding by pharmacies. On Oct. 9, 2012, at the height of the crisis, two members of the U.S. House of Representatives promised to introduce legislation aimed at increasing federal oversight.
A principal motivation for the effort appears to be a widespread perception that FDA does not currently regulate drug compounding at all. That is not true. In fact, section 353a of the Federal Food, Drugs, and Cosmetics Act, or FD& Act, spells out what drug compounding is and what pharmacists who compound medications must do.
What Federal Law Requires
The FD&C Act specifies that compounding must be done pursuant to a prescription order that indicates a particular patient’s need for a customized dosage. The law further clarifies that compounding involves making dosage forms from a bulk drug and other ingredients. Simply mixing a medication according to labeled instructions or converting a tablet to a liquid for pediatric or geriatric use does not constitute compounding.
When pharmacists, or pharmacy technicians working under the direct supervision of pharmacists, prepare compounded drugs, they must adhere to any relevant standards detailed in the U.S. Pharmacopeia or the National Formulary. If such standards do not exist, exact details on how and why the product was compounded must be recorded and made available to regulators.
The law also states that compounded drugs should be prepared in limited amounts and should not be “essentially copies of a commercially available drug product.” As shortages of older and special-use medications become more common, however, compounding pharmacies have increasingly filled a gap in the drug supply chain for products like premixed injectable steroids. A patient must still present a prescription to receive a compounded medication prepared in advance.
Under broad authority granted to the agency to ensure the quality and safety of drug products, pharmaceutical production, and drug prescribing and sales, FDA officials can investigate, warn and sanction any pharmacy or pharmacist that violates rules issued to implement sec. 353a.
What Federal Law Does Not Require
The FD&C Act explicitly exempts legitimately prescribed and prepared compounded drugs from review, approval, adverse event reporting, storage and labeling requirements placed on prescription and over-the-counter drugs. In practical terms, this means compounded dosages do not have to be approved as new drugs before being dispensed, nor do they need to be proven safe for patients younger than 18 years of age before being administered to youngsters. Also, pharmacies that prepare compounded medications can deliver and dispense them in packages, and with instructions, other than those approved by FDA.
Is Large-Scale Contract Drug Compounding Legal?
Federal law does not set a numerical value on the limited amount of compounded medications state-licensed pharmacies can prepare or prevent pharmacies from shipping compounded drugs across state lines. Also, while the FD&C Act does prohibit pharmacies from advertising specific compounded drugs, pharmacies can legally alert potential clients about their capacity to fill large orders for compounded dosages.
Federal officials and pharmaceutical manufacturers have tried to set limits on large-scale compounding, repeatedly raising the question of how many products a pharmacy should be allowed to make before it gets reclassified as a factory. As consistently, courts have ruled that only states can license facilities as pharmacies or pharmaceutical plants. Links to each state pharmacy board’s regulations for drug compounding can be found here.
Within this uneven regulatory environment, the number of pharmacies that offer drug compounding services has grown steadily over the last decade. International Academy of Compounding Pharmacists David Miller told the Associated Press that between 2009 and 2012 alone, 2,500 U.S. pharmacies added compounding, bringing the total to more than 7,500.