What are compounding pharmacies
This is a specific area of practice where pharmacists customize medications for individual patients by mixing raw ingredients. Pharmacists, as directed by a physician customize the strengths and dosage forms of a medication. This makes it easier for patients to take their medication which improves treatment.
How many compounding pharmacies are there in the country
There are approximately 56,000 community-based compounding pharmacies in the United States of which half serve local health providers and patients. 7,500 compounding pharmacies provide advanced compounding services and 3,000 of these also practice sterile compounding.
How are compounding pharmacies different from other pharmacies
Many regular pharmacies only dispense drugs in fixed dosages, strengths, and routes provided by the manufacturers. Compounding pharmacies can change the dosages, strengths, and routes that are not available in commercial products. For example:
Because compounding pharmacies mix different ingredients to make one product, most of the medications will have shorter expiration dates than commercial products.
What types of medications are frequently compounded
Here are the types of medications:
What are examples of drugs that are compounded
The most common drugs compounded are topical preparations (e.g., creams, lotions, ointments, suppositories, and pastes) and liquids for oral administration (e.g., elixirs, syrups, and suspensions). Examples of specific medications that are commonly made in compounding pharmacies are:
How are compounding pharmacies regulated
Since many compounded products are tailored to a specific patient, they do not always require the Food and Drug Administration’s (FDA) approval. Like other pharmacies, compounding pharmacies and pharmacists are licensed and regulated by the State Boards of Pharmacy (SBOP). The Drug Enforcement Administration (DEA) regulates the handling of controlled substances. Standards of practice are set by the United States Pharmacopeia (USP) and the Pharmacy Compounding Accreditation Board (PCAB). Air quality, sterility-testing products, and training and testing of personnel in aseptic technique are examples of standards that are enforced. Contamination of sterile products can cause harm to patients; regulation and inspection is key in preventing such events. The ingredients for compounding medications are from FDA-registered and inspected facilities like the Professional Compounding Centers of America (PCCA).
What are best practices and standards for compounding pharmacies
Compounding pharmacists must follow state and federal compounding laws, regulations, and guidelines. This ensures that medications dispensed to patients are safe to use and quality is maintained. Best practices and standards include:
If even one of these standards are not properly followed or enforced in the pharmacy, problems may occur posing dangerous risks to patients. A recent example occurred in 2012. There was a fungal meningitis outbreak in people who used contaminated epidural steroid products that were compounded by the New England Compounding Center (NECC) in Framingham, Massachusetts. This resulted in the shutdown of the company and massive recalls in their products as well as from their sister company, Ameridose. Interesting questions arose such as faulty regulation and if there were actual adoption of specific standards by NECC. The FDA and lawmakers are discussing new plans to prevent similar future incidents. Proposals like the Verifying and Legality In Drug (VALID) Compounding Act about giving more regulating power to the FDA has been brought up to legislation. Discussion about creating more federal regulations for larger grand-scale compounding pharmacies have also been brought up. There were also suggestions of required standards, guidelines, and accreditation for all compounding pharmacies.
Despite these recent news, compounding pharmacies are still an essential need in healthcare. Not all drugs can be supplied by commercial manufacturers. Patients should not be discouraged from using compounding pharmacies. If patients have more questions, they should discuss them with their healthcare provider.
Board of Pharmacy California Code of Regulations. Repeal Section 1716.2. Record Requirements. Compounding for Future Furnishing.
This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.
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