Did you know that there are different types of pharmacies? Most of us are familiar with community pharmacies: those big nationwide chains or those found in supermarkets. Compounding pharmacies are different from community pharmacies. According to the American Pharmacists Association, of the roughly 56,000 pharmacies in the United States, only about 7,500 offer compounding services. These facilities offer specialized formulations and customized medications tailored to an individual patient’s needs.
But what are compounding services? And what is the difference between a compounding pharmacy and a community pharmacy? In this article, we’ll investigate the differences between these types of pharmacies and what role compounded medications play in our national healthcare system.
What is drug compounding?
Pharmaceutical compounding—or drug compounding—is a specialized pharmacy practice that involves preparing customized medications tailored to meet the unique requirements of individual patients. This process extends beyond the standard manufacturing of commercially available drugs and allows pharmacists to craft bespoke pharmaceutical solutions.
Compounding pharmacists mix, blend, and adjust active ingredients, binders, fillers, and flavorings to formulate medications in various forms, such as creams, ointments, capsules, suspensions, or suppositories.
This approach is particularly valuable for patients with distinct needs, such as those with allergies or sensitivities or individuals who require personalized dosage strengths that are not readily available.
What is the difference between a community pharmacy and a compounding pharmacy?
Compounding services are often performed in a compounding pharmacy or an outsourcing facility. Compounding facilities offer custom-made compounded medicine specifically designed for the individual patient’s medical needs. The drug products these compounding centers provide are not commercially available or mass-produced by drug manufacturers. Only about 14% of pharmacies nationwide offer compounding services.
Community pharmacies are far more common and can be found in hospitals, nationwide chains (like Costco or CVS), or supermarkets. These facilities sell FDA-approved meds mass-manufactured by drug manufacturers.
Community pharmacies can offer compounding services. These facilities are subject to federal law, which dictates the compounding services they can provide. Furthermore, each state has regulations and licensing requirements for compounding services.
In short, compounding pharmacies are far less common than community pharmacies. They offer specialized services and drugs tailored to the individual. Community pharmacies can perform some of the same services but are more likely to offer commercially available FDA-approved prescription drugs.
Why do some people need compounded drugs?
Healthcare professionals prescribe compounded drugs to suit a patient’s medical needs. There are various reasons why a patient may need a bespoke form of medication.
These may include:
- Allergies or sensitivities to specific ingredients (like dyes or gluten) in commercially available medications
- Need for customized dosage forms that are not available in commercial products
- Pediatric patients who require age-appropriate medication forms and flavors
- Geriatric patients with difficulty swallowing or unique medication preferences
- Unavailability of a specific medication in its commercially manufactured form (i.e., a drug shortage)
- Requirement for combination therapies, combining multiple medications into a single dosage
- Patients who require discontinued or out-of-stock medications
- Individuals with specialized needs, such as hormone replacement therapy, pain management, or dermatological conditions
In these cases, compounded drugs play a vital role in a patient’s medical care and well-being.
Are there different types of compounded drugs?
Compounded drugs fall into two categories: sterile and non-sterile.
Non-sterile compounded drugs:
These are compounded medications prepared in a non-sterile environment, such as a community pharmacy or compounding laboratory. Non-sterile compounding can take various forms, including creams, ointments, capsules, oral solutions, and suppositories. They are typically used for topical applications, oral administration, or other non-invasive routes of drug delivery.
Some examples of non-sterile compounded drugs include:
- Customized topical creams or ointments for skin conditions (e.g., eczema, psoriasis)
- Flavored suspensions or oral solutions for pediatric patients with difficulty swallowing pills
- Bioidentical hormone replacement therapy (BHRT) preparations tailored to individual hormone need
- Transdermal gels or patches for hormone replacement or pain management
- Compounded capsules with specific dosage strengths or combinations of medications
- Customized suppositories for rectal or vaginal administration
- Medicated lozenges for patients who have trouble swallowing
- Dentistry compounding, such as customized oral rinses or dental gels for specific oral health needs
- Personalized medications for patients with allergies or sensitivities to commercial drug ingredients (like dyes or preservatives)
Sterile compounded drugs:
Sterile compounded drugs are prepared in a sterile environment, often within a certified, larger compounding pharmacy that is often similar to a mass production facility. Sterile compounded drugs are intended for use in more critical and sensitive medical situations, such as injections, infusions, or ophthalmic preparations. Sterile compounding ensures the medication is free from contamination, making it suitable for direct introduction into the bloodstream or other body sites.
Some examples of sterile compounded drugs include:
- Intravenous (IV) antibiotics or antifungals for severe infections
- Specialty chemotherapy preparations for cancer treatment
- Parenteral nutrition solutions for patients who cannot receive nutrition orally
- Intravitreal injections for the treatment of eye conditions like macular degeneration
- Epidural or intrathecal pain management medications delivered directly to the spinal cord
- Sterile ophthalmic solutions and ointments for eye surgeries and treatments
- Radiopharmaceuticals used in nuclear medicine imaging and therapies
- Intravenous immunoglobulins (IVIG) for autoimmune disorders or immunodeficiency
- Sterile injectable medications for anesthesia during surgeries
Are compounded drugs safe?
Compounded drugs fulfill a critical medical need for certain patients but are not verified for safety or efficacy by the Food and Drug Administration (FDA). That doesn’t mean that these drugs are totally unregulated, however. The FDA, state Boards of Pharmacy, and the United States Pharmacopeial (USP) Convention all play a role in making sure that human drug compounding adheres to particular safety and quality standards.
Section 503A in the Federal Food, Drug, and Cosmetic Act mandates that pharmacy compounding be based on a valid prescription written by a licensed prescriber. In addition, a licensed pharmacist or physician must prepare compounded drugs.
Outsourcing facilities that make compounded drugs must register with the FDA. They are inspected to strict standards, ensuring adherence to current Good Manufacturing Practices (CGMP), as detailed under section 503B of the FD&C Act.
Compounding pharmacies are also inspected and regulated by their state Board of Pharmacy. These inspections and regulations are specifically intended to ensure the quality and safety of production conditions and ingredients used for drug compounding.
In addition, the USP sets quality expectations for ingredients used by compounding pharmacies. Most states’ Boards of Pharmacy uphold and ensure these standards.
503A vs. 503B pharmacies
503A compounding pharmacies are regulated by the states they are located in, in accordance with the United States Pharmacopeia (USP). These pharmacies make drugs used to fit a patient’s specific needs.
503B compounding pharmacies are wholesale drug manufacturers that are overseen by the FDA. These facilities make large quantities of compounded drugs to both state and federal quality standards. If your medication is coming from a 503B compounding pharmacy, you can be sure that:
- The drug contains the correct dosage of active ingredients
- The drug is sterile
- The drug is good until its expiration date
The Compounding Quality Act
While compounded drugs do not undergo the same verification process as FDA-approved drugs, they are still subject to rigorous inspection and regulation. However, it is essential that you only obtain compounded drugs from a licensed provider. Compounded drugs produced in unsanitary conditions can result in serious medical problems for patients. For example, in October 2012, a pharmacy in Massachusetts produced compounded drugs that were intended to be sterile but instead were contaminated with fungus, which resulted in a meningitis outbreak that resulted in over 750 infections and more than 60 deaths.
This outbreak led Congress to pass the Compounding Quality Act in 2013. This law gives the FDA greater oversight of compounding pharmacies, ensuring that they follow good manufacturing practices. As a result, compounded drugs are safer and more reliable for consumers.
Patients receiving compounded drugs should work with their prescriber to ensure that a licensed pharmacist is formulating any specialized medication in a regulated facility. For reference, the Pharmacy Compounding Accreditation Board has a search tool to help you find a regulated compounding pharmacy near you.
Compounding pharmacies play a valuable role in the medical care for patients with singular medical needs. The unique formulations produced by these facilities are critical for those with certain sensitivities or administration requirements. They are also essential for times when FDA-approved medications are out of stock. Ask your pharmacist or healthcare provider about compounding pharmacies and medication for additional information.
