With the current attention being focused on the fungal meningitis outbreak in the United States that appears to be the result of contaminated epidural steroid injections manufactured by the compounding pharmacy, New England Compounding Center (“NECC”), you may wonder, what is a compounding pharmacy?
What Is Compounding?
According to the Professional Compounding Centers of America (“PCCA”), a national network of pharmacists who compound drugs, “Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are “made from scratch” – individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs … Its practice dates back to the origins of pharmacy, although compounding’s presence in the pharmacy profession has changed over the years.
“In the 1930s and 1940s, the majority of prescriptions were compounded. With the advent of mass drug manufacturing in the 1950s and ‘60s, compounding declined as the pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms. However, this “one-size-fits-all” approach to medication meant that some patients’ needs were not being met. Within the last few decades, however, compounding has experienced a renaissance as modern technology and innovative techniques and research have allowed more pharmacists to customize medications to meet a patient’s unique needs …
“With a physician’s consent, a compounding pharmacist can adjust the strength of a medication; avoid unwanted ingredients, such as dyes, preservative, lactose, gluten, or sugar; add flavor to make the medication more palatable; [and,] prepare medications using unique delivery systems. For patients who find it difficult to swallow a capsule, a compounding pharmacist may prepare the drug as a flavored liquid suspension instead. Other medication forms include topical gels or creams that can be absorbed through the skin, suppositories, sublingual troches, or even lollipops.”
On October 4, 2012, the International Academy of Compounding Pharmacists (“IACP”), a 2,700-member organization of compounding pharmacists, technicians, and student pharmacists, issued a statement responding to the recent fungal meningitis outbreak. The IACP’s statement notes that more than half of the approximately 56,000 community-based pharmacies in the United States provide some level of basic compounding services to local patients and physicians, and about 7,500 pharmacies specialize in advanced compounding services (approximately 3,000 of the 7,500 provide sterile compounding services). About 1% to 3% of prescriptions filled in the U.S. are compounded pursuant to prescriptions for individual patients.
Who Regulates Compounded Drugs?
Following the FDA’s drug approval process is required for mass-produced drugs that are manufactured by large pharmaceutical companies. These are the medications you may typically obtain from your local retail or mail-order pharmacy that are filled pursuant to a prescription. The pharmacist usually counts out the required number of pills, tablets, capsules, or the like from a larger bottle of the prescribed medication or pours the liquid medication from a larger container stored on a shelf or in a drawer behind the counter of the pharmacy which the pharmacist then places in a new bottle or container with the patient’s name, the name of the prescriber, the name of the medication, the quantity of the medication in the patient’s bottle, the dosage of the medication, dosing instructions, and other required information printed on a label on the bottle or container before the medication is handed to the patient. The FDA highly regulates the manufacture and distribution of these drugs.
Compounded drugs are not regulated by the FDA but are subject to state regulations established by the state’s Board of Pharmacy in the state in which the compounding pharmacy is located. Nonetheless, the ingredients used in compounds must come from facilities that are registered with and inspected by the FDA.
If you or someone you know may have contracted fungal meningitis or may have been injured or harmed as a result of a compounded drug, you should promptly consult with a local medical malpractice attorney who may be able to investigate your drug claim for you.
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