What Is a Compounding Pharmacy and How Do They Operate?

When you think of a pharmacy, you probably envision a community pharmacy—whether it’s part of a large chain or an independent establishment. You may also think of hospital pharmacies. While these are common and vital, other types of pharmacies exist, such as compounding pharmacies, which offer unique benefits to many people.

Compounding pharmacies provide specialized services that may not be available at traditional pharmacies. They prepare customized medications by mixing and combining ingredients according to specific needs.

This article explores what compounding pharmacies are, the services they offer, who can benefit from them, and where to find them.

What Is a Compounding Pharmacy?

A compounding pharmacy is a specialized type of pharmacy that customizes medications for individuals, their family members, or even pets. Some people or animals require medications that are not commercially available, meaning they are not mass-produced or found in standard pharmacies. This is where compounding pharmacies come in.

Compounding pharmacies create two main types of compounds: sterile and non-sterile. Some pharmacies specialize in one, while others handle both types.

• Sterile compounds include injections, eye drops, and infusions. These require extra precautions, as contamination could lead to serious infections. Sterile compounds are made in controlled environments designed to minimize these risks.
• Non-sterile compounds include creams, capsules, and suppositories, with a lower risk of contamination.

Compounding pharmacies also fall into two general categories based on U.S. legislation:

• 503A compounding pharmacies: These pharmacies compound medications based on a prescription from a healthcare provider.
• 503B compounding pharmacies: These pharmacies also create medications based on prescriptions but can compound sterile medications in bulk and distribute them to healthcare facilities like hospitals and clinics. These are sometimes referred to as “outsourcing facilities.”

How Do Compounding Pharmacies Differ from Traditional Pharmacies?

Many community and hospital pharmacies provide compounding services but often lack the specialized equipment or certifications that compounding pharmacies have. As a result, the medications they prepare tend to be simpler.

For instance, a community pharmacy may combine different creams to create a compounded cream or mix oral liquid medications. In hospitals, pharmacies often prepare sterile medications for infusion.

While compounding pharmacies can handle these tasks, they are also capable of creating more complex formulations. Moreover, federal regulations and state-specific laws distinguish the services provided by compounding pharmacies from those offered by community or hospital pharmacies.

How Common Are Compounding Pharmacies?

Compounding pharmacies are somewhat common. The American Pharmacists Association reports that there are around 56,000 community pharmacies in the U.S., with approximately 7,500 specializing in compounding. As a result, you may not always find a local compounding pharmacy able to fill your specific prescription. However, some compounding pharmacies operate across multiple states, offering mail-order services.

Additionally, around 70 U.S. companies are FDA-registered as outsourcing facilities, which focus on providing sterile medications to healthcare institutions rather than individual prescriptions.

Why Might You Need Compounded Medications?

There are many situations where compounded medications are necessary. Standard medications produced by pharmaceutical companies may not always meet your needs. Some common reasons for needing compounded medications include:

• Adding flavoring to an unpleasant-tasting medication
• Allergies to inactive ingredients in commercial medications
• Accessing a medication that is unavailable or on backorder
• Requiring a medication in a different form, such as liquid instead of pills
• Needing a specific dosage strength

What Types of Medications Do Compounding Pharmacies Prepare?

Compounded medications can take a variety of forms. For example, if you or your child has trouble swallowing pills, a compounding pharmacy can convert the medication into a gummy, chewable tablet, or even a hard candy. Similarly, if you need a different strength than what’s available in stores, compounded liquids such as syrups or suspensions can be prepared to meet your exact needs.

Each compounding pharmacy may offer different services and may specialize in specific medical areas, such as veterinary medicine, men’s health, or dermatology.

Examples of Compounded Medications

A pharmacist or technician follows specific formulations to create compounded medications, which may be derived from bulk ingredients, commercial drug products, or a mix of both. Here are some examples:

• Multi-ingredient topical pain creams
• Hormone therapy creams, capsules, and suppositories (e.g., estradiol and progesterone)
• Rectal suppositories for hemorrhoids or anal fissures
• Nipple ointments for breastfeeding-related irritation
• Magic mouthwash for mouth sores
• Liquid medications like omeprazole or lansoprazole for children
• Diazepam suppositories for chronic pelvic pain
• Sterile antibiotic eye drops
• Sterile nutrition infusion therapies

How Can I Find a Compounding Pharmacy Near Me?

To locate a nearby compounding pharmacy, start by asking your healthcare provider if they recommend any specific pharmacies. They might refer you to a compounding pharmacy they trust or one that specializes in your particular needs.

You can also use online resources like the Alliance for Pharmacy Compounding’s directory or the Professional Compounding Centers of America’s website. Simply enter your location, and you’ll find compounding pharmacies in your area.

Even your local community pharmacy might offer compounding services, so it’s worth asking your pharmacist.

How Is the Safety of Compounded Medications Ensured?

Compounded medications are not FDA-approved, meaning they are not directly evaluated by the FDA for safety or effectiveness. However, the FDA permits compounding pharmacies to prepare medications when there is a medical need.

Three main groups regulate compounded medications to ensure their quality: the FDA, state Boards of Pharmacy, and the United States Pharmacopeia (USP) Convention.

• USP: Sets the standards for quality ingredients and proper compounding methods.
• State Boards of Pharmacy: Regulate compounding pharmacies at the state level and inspect them to ensure compliance.
• FDA: While it doesn’t approve compounded drugs, it may inspect compounding pharmacies and the facilities producing the ingredients used.

Additionally, 503B outsourcing facilities are required to follow stricter FDA regulations and undergo inspections based on current Good Manufacturing Practices (cGMP) to ensure quality.

At MediServ Pharmacy, located in the Bronx, New York, we understand the importance of personalized care. As a local pharmacy committed to meeting your specific health needs, we offer professional compounding services to create custom medications that suit your unique requirements. Whether you need compounded creams, specialized dosages, or liquid forms of medications, our experienced pharmacists are here to help.

If you’re in need of compounded medications or have questions about how compounding can benefit you, don’t hesitate to reach out to us. Visit MediServ Pharmacy today or contact us for more information. Your health is our priority!