What Is A Compounding Pharmacy?

If your doctor’s office has given you a prescription with instructions to fill it at a compounding pharmacy, you might be wondering what exactly this means. There are 56,000 community pharmacies in the U.S. Only around 7,500 are compounding pharmacies. Please continue reading to find out more about human drug compounding and compounded medications. 

What is a Compounding Pharmacy?  

A compounding pharmacy is a pharmacy that creates customized medications that are not available commercially. In other words, compounding pharmacies can provide certain medication strengths that are not available with pre-made drug products, offer alternative dosage forms, or even combine different active ingredients to create personalized solutions. 

However, compounded products are not regulated by the U.S. Food and Drug Administration (FDA), which means that the FDA does not verify their safety and effectiveness. Despite this, compounding pharmacies provide many benefits for individuals with unique medication needs or requirements, as well as solutions for medications that are in short supply or on backorder. It is crucial to choose a reputable compounding pharmacy to ensure the safety and efficacy of the medications.    

Key Differences: Compound Pharmacy vs Regular Pharmacy

Regular or traditional pharmacies dispense pre-made drugs manufactured on a commercial scale by pharmaceutical manufacturers. 

Compounding facilities create customized dosages and dosage forms of the same medication to meet an individual patient’s needs. These facilities can be a standalone pharmacy practice or part of other healthcare facilities. 

Pharmaceutical compounding is performed by licensed pharmacists using active pharmaceutical ingredients. Compounding pharmacists learn more than basic compounding processes at pharmacy school. Also, compounding pharmacies have special compounding tools and equipment.

What Exactly Does A Compounding Pharmacy Do?

Compounding pharmacies make (compound) drug products from scratch, using pharmaceutical-grade ingredients approved by the FDA. In other words, while traditional, community-based pharmacies dispense ready-made medications, compounding pharmacies make customized medications that are not available from commercial drug manufacturers. Pharmaceutical compounding helps to meet the needs of an individual patient that can’t be met by commercially available medications. 

Compounding pharmacists use active pharmaceutical ingredients to make a formulation according to a patient’s needs. 

In general, compounded medications are made in a dosage form, such as creams, ointments, transdermal gels, liquids, suppositories, lozenges, and capsules. Compounding pharmacists do not usually make pills and tablets. Some compounding pharmacies make non-sterile preparations like ointments, creams, and capsules, while others make sterile products like eye drops or injections. 

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Common Compounded Medications 

Compounded medications make up only about 1-3% of the total prescriptions dispensed in the United States. The following are some of the most common compound medications:

• Pain medications (lidocaine, baclofen, gabapentin, cyclobenzaprine).

• Hormone replacement therapy (estrogen, progesterone, testosterone). 

• Skin conditions (hydrocortisone, zinc oxide, nystatin).

• High blood pressure (atenolol, enalapril).

• Acid reflux (lansoprazole, omeprazole).

Why Choose a Compounding Pharmacy?  

Your healthcare provider might give you a prescription that can only be filled at a compounding pharmacy. There can be various reasons for prescribing a compounded drug, some of which are listed below. 

Allergies

You have an allergy to one or more of the inactive ingredients in a commercially available drug. Common allergens in medications include gelatin, lactose, and dyes. 

Compounding facilities can make the drug for you containing the active ingredient but without the allergens so that you won’t have an allergic reaction. 

Prescription Medications for Children

Many medications are formulated for adults and the dosages are not appropriate for children. Also, younger children may not be able to swallow pills and may need medication in liquid form. A licensed pharmacist at a compounding facility can customize the dose or dosage form for a child. 

Hazardous Drugs

Some oral medications contain multiple active ingredients. Taking these drugs by mouth can prove dangerous. A customized medication may include some of the active ingredients in a cream form so that it can be applied directly to the affected area, thereby bypassing the digestive tract and reducing absorption of the drug into the bloodstream. This can help to prevent the systemic adverse events associated with a drug.

Customized Medicines

When health professionals prescribe multiple medications to apply in the form of topical creams in a particular order or altogether, it can be quite inconvenient. Pharmacy compounding can combine these drugs according to your doctor’s prescription. This will allow you to use one cream instead of three or four different tubes to treat your medical condition. These types of compounded drugs are common for skin conditions, pain management, topical hormone therapy, prescription eye drops, and suppositories for hemorrhoids.

Commercially Unavailable Medications

Some medications are not profitable enough for large pharmaceutical companies to make. If you need such a medication that is not available commercially, a compounding pharmacist can make it for you.

Off-Label Medication Use

Sometimes healthcare providers prescribe an FDA-approved medication to treat a condition for which it is not FDA-approved. This might require the dosage to be adjusted. Compounding pharmacies can create these drugs for off-label use. For example, naltrexone 50 mg is used to treat alcohol and opioid use disorders. This medication is used off-label to treat autoimmune conditions at doses of 1 to 5 mg. It is not possible to split a 50-mg tablet into such a small dose. With pharmaceutical compounding, the pharmacist can place 3 mg of the drug in a capsule.

What Is The Most Appropriate Reason To Compound a Prescription in the Pharmacy?

Here are a few examples of situations in which a compounding pharmacist can make customized compounded medications to meet a patient’s unique needs:

• In case a young child cannot swallow tablets and needs a liquid dose of a medicine that is only available commercially in tablet form.

• If a child needs a smaller dose of a medication that is available only in adult dosages.

• If a person is allergic to one of the inactive ingredients in commercially marketed drugs.

• When a patient requires a flavoring to be added to a medication to make it more palatable.

• If a person needs a drug that is currently in short supply.

• In case patients require a drug that has been discontinued.

Note: Making copies of commercially available medications is not allowed by law. 

Veterinary Solutions: When Is Compounding Most Appropriate for Pets?

Compounded medications for pets are made by mixing or altering commercially available drugs. This can include mixing one medication with others, adding flavoring, changing the strength, or preparing a different dosage form. A compound medication can meet a specific need for your pet that can’t be met by commercially available medications.

Note: By law, a compound medication cannot be the same as an approved medication.

Examples of compounded medications for pets include

• A flavored oral liquid made from an unflavored tablet.

• A gel form of medication instead of a pill. 

• A combination of medications for application to the skin.

The Role and Training of Compounding Pharmacists  

What Is The Difference Between a Compounding Pharmacist and a Regular Pharmacist?

Compounding pharmacists customize medications for individual needs, unlike regular pharmacists who dispense commercially manufactured drugs. Compounding pharmacists use specialized skills and tools to prepare medications for patients who cannot be treated with FDA-approved medications. For example, if a patient has an allergy to a certain dye and needs a medication prepared without it or if a patient is unable to swallow a pill and needs a medication in liquid form.

Education and Certification Requirements 

To become a compounding pharmacist, you need to: 

• Earn a Doctor of Pharmacy (PharmD) degree.

• Clear the North American Pharmacist Licensure Examination (NAPLEX).

• Complete a residency, ideally at a pharmacy that specializes in compounding.

• Obtain board certification and add the letters BCSCP after your name (Board Certified Sterile Compounded Preparations).

Responsibilities, Techniques, and Equipment  

Compounded medications are made according to standards developed by the United States Pharmacopeia (USP) Convention, which defines pharmaceutical compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.” 

The Compounding Quality Act allows facilities that compound sterile drugs to register as outsourcing facilities.

Regulation and Compliance Around Compounding Pharmacies

Government Agencies

A compounding pharmacy is regulated by federal law and state law. Three government agencies are involved, namely state boards of pharmacy, the FDA, and the Drug Enforcement Administration (for compounding pharmacies that handle controlled substances). 

Section 503A of the Federal Food, Drug, & Cosmetic Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility or by a licensed physician that is not registered with the FDA as an outsourcing facility. Section 503B applies to human drug compounding within an outsourcing facility.

PCAB Accreditation

An independent board called the Pharmacy Compounding Accreditation Board (PCAB) performs strict inspections and gives an official seal of approval to compounding pharmacies that meet rigid requirements. Only about 180 compounding pharmacies in the US have PCAB accreditation. 

PCCA for Compounding Education and Supplies

The Professional Compounding Centers of America (PCCA) is the leading supplier of pharmacy chemicals, equipment, and compounding education to compounding pharmacies and pharmacists.

Safety Concerns

What Are The Risks of Getting Medication From a Compounding Pharmacist?

Compounding pharmacies are safe in general. However, things can sometimes go wrong. In 2012, there was a fungal meningitis outbreak after patients received compounded spinal cord injections prepared at the New England Compounding Center (NECC). A number of things had gone wrong with these complex compounding services, affecting drug quality and safety.

What Are The Risks of Buying Compounded Drugs from Online Pharmacies?

The U.S. Food and Drug Administration (FDA) encourages consumers to be vigilant while buying compounded drugs from an online pharmacy or telehealth service. Purchasing medications from unregulated or unlicensed sources can expose you to fake or poor-quality products. In contrast to hospital pharmacies, when you purchase compounded drugs through online pharmacies, you cannot be sure of the qualifications of the compounding pharmacist and whether the compounded drug meets quality standards.

Accessibility for Compounded Medications  

Does Insurance Pay For Compound Drugs?

After the outbreak of fungal infections from drug products made at a compounding pharmacy, many insurance companies stopped paying for compounded drugs. If your specific policy does not cover drugs made at a compounding pharmacy, you will need to pay for the medication out-of-pocket. 

Why Are Compounding Pharmacies Cheaper?

Compounding pharmacies can be cheaper than standard pharmacies because they can prepare drugs using less expensive ingredients or at lower doses than commercially available drugs.

Looking for ways to lower your prescription costs? Check out our blog for creative ways to save at the pharmacy.

How To Locate a Compound Pharmacy  

You can use the PCCA tool to find a licensed compounding pharmacy in your area.

Common Questions About Compounding Pharmacies  

Does Insurance Cover Compounding Pharmacy?

Many insurance companies have stopped covering compounded drugs after safety incidents, leading to out-of-pocket expenses for patients.

What Is Compound Medication For Weight Loss?

Examples of a compound medication for weight loss include semaglutide, which is found in FDA-approved medications such as Ozempic and Wegovy, and tirzepatide, which is found in FDA-approved medications such as Mounjaro and Zepbound. A compounded weight loss medication is a customized version of a weight loss drug that's made by a compounding pharmacy based on a patient's specific needs. These drugs may be prepared by a compounded pharmacy with chemically altered ingredients or mixed with other ingredients. The FDA does not regulate or approve compounded drugs because their safety and effectiveness are not verified. 

Are Compounded Bioidentical Hormones Effective?

Compounded bioidentical hormone replacement therapy contains bioidentical hormones (estrogen, progesterone) in customized ratios to treat symptoms of menopause. However, healthcare providers do not recommend compounded bioidentical hormone replacement therapy because the purity, strength, and safety are not verified or regulated.

What Is The Difference Between A Specialty Pharmacy And A Compounding Pharmacy?

A specialty pharmacy is a state-licensed pharmacy that dispenses medications to people living with rare and complex medical conditions, such as cancer, cystic fibrosis, multiple sclerosis, organ transplantation, HIV/AIDS, and others. In other words, specialty pharmacies act as distribution channels for expensive or complex drugs that are not typically required by the general population. Compounding pharmacies dispense customized versions of commonly prescribed medications.

What is an Example of a Compound Medication?

An example of a compound medication is a customized dose for a person who cannot take the commercially available dose, a liquid form of medicine for a person who cannot swallow pills, a sugar-free version for a person with diabetes, or a mixture of two or more creams to create one topical product for convenience of application.