Compounding Pharmacies became a trending subject in 2012 following the outbreak of meningitis as a result of compounded drugs. This happened when the New England Compounding Centre (NECC) discovered a contamination in the drugs it sold in all 50 states. The NECC is a compounding pharmacy.
It was discovered that fungal contamination of at least one of the products sold is responsible for the meningitis outbreak. A product comprised of single-shot syringes filled with a steroid preparation.
This exposed over 13,000 people in the states to the risk of the deadly fungal meningitis. To curtail the risk, the New England Compounding Centre (NECC) hurriedly recalled the 2,410 different drugs it sold in all 50 states.
This raises serious questions about compounding pharmacies, which make some 3% of drugs dispensed in the U.S.
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What is compounding pharmacies?
The typical role of compounding pharmacies is to create drugs for patients with needs that can’t be met by commercially available drugs. Often times, a doctor prescribes drugs which can’t be seen in the commercial drug shop. In this situation, a compounding pharmacy is needed to formulate these prescription.
In pharmacy, drug compounding is the process of combining, mixing, or altering ingredients to make medications which suit the needs of particular patients. Compounding includes the combining of two or more drugs.
Compounding pharmacies involves combining, mixing, or altering ingredients to make medications which suit the needs of particular patients
Are compounding pharmacies regulated?
The practice of compounding is regulated by state boards of pharmacy. All pharmacists and pharmacies engaged in compounding are subject to oversight by both US federal and state authorities.
Who ensures that drugs made by compounding pharmacies are safe?
The Food and Drug Administration traditionally regulates drug manufacturers. But states regulate pharmacies.
Three government agencies regulate compounding pharmacies. They include:
#1. State boards of pharmacy: the state board of pharmacy ensure that pharmacies follow state regulations for pharmacy practice.
#2. The US Food and Drug Administration (FDA) : the FDA regulates “the integrity of the drugs” and the active pharmaceutical ingredients from which they are made.
#3. The Drug Enforcement Administration (DEA): The DEA regulates compounding pharmacies’ handling of controlled substances.
The independent Pharmacy Compounding Accreditation Board (PCAB) offers its official seal of approval to pharmacies that voluntarily pass strict inspections and other rigid requirements. Over 180 compounding pharmacies have this strict PCAB accreditation.
The NECC, the company at the heart of the fungal meningitis outbreak, was not PCAB accredited.
But there’s a grey area. As some compounding pharmacies get larger, they begin to act like small drug manufacturers. So when does a large compounding pharmacy regulated by a state pharmacy board become a small drug manufacturer regulated by the FDA?
When a large compounding pharmacy regulated by a state pharmacy board become a small drug manufacturer regulated by the FDA
An expert says there’s no bright line on this question.
A 1997 law extending the FDA’s authority over compounding pharmacies was largely struck down by a 2002 Supreme Court decision. Later in 2002, the FDA issued a guidance in which it says it can regulate compounding pharmacies under certain circumstances. These include:
- Making drugs before a doctor has written a prescription for them, except in “very limited quantities.”
- Producing or making drugs with commercial-scale manufacturing or testing equipment.
- Making drugs for resale to individual patients.
- Making drugs commercially available in the marketplace or copying FDA-approved drug products.
However, this guidance is not an official FDA regulation and does not have the force of law.
How many compounding pharmacies are there?
According to the IACP, there are 80,000 community-based pharmacies in the U.S. About half of them directly serve local patients and doctors.
Some 7,500 compounding pharmacies specialize in what the IACP calls “advanced compounding services.” Some 3,000 of these pharmacies make sterile products. The tainted steroid shots made by NECC were supposed to have been sterile.
How would I know if the drug I’m getting came from a compounding pharmacy?
The NECC has taken down its web site and issued a statement: “For the foreseeable future, NECC staff and professionals will be singularly focused on providing full cooperation with relevant public agencies and carrying out this recall professionally and expeditiously.”
If you receive medicines at a clinic, hospital, or doctor’s office, ask whether the medication came from a compounding pharmacy. It would also be a good idea to ask whether that pharmacy has PCAB accreditation.
How do I choose a compounding pharmacy?
Before choosing a compound pharmacy, it’s a good idea to find out about the pharmacists and what type of qualifications they have. Ideally, they should have received compounding training and certification from a recognized center of training. Pharmacists should be able to research and develop compounding formulas.
Some insurance plans cover all compounded medications, others only cover certain active ingredients, and some do not cover compounded medications at all.