What Is a Compounding Pharmacy? (2024)

When you have to go on a medication, your doctor will probably prescribe a premade one that's FDA-approved. But sometimes, they may want you to go on a compounded medicine — one specifically made for your needs.

About 1% to 3% ofprescriptions in the U.S. are for compounded drugs.

These medicines may be free of certain allergens or have a dosage that’s different than the preset dosagesavailable. They may change the formula for an existing medicine to meet your specific needs.

The risks of compounded medicines are different so the laws that govern compounding pharmacies and compounded drugs differ from a traditional drug manufacturer or pharmacy.

How Is a Compounding Pharmacy Different From a Regular Pharmacy?

Compounding pharmacies sell custom-made medicines. Retailor hospital pharmacies (also known as community pharmacies) sell medicines made by manufacturers, but they can still offer certain compounded drugs. They just may not offer all the exact mixtures you need, especially if what you need must be made in a special setting to ensure safety. In that case, you may need to go to a compounding pharmacy, specifically.

There are about 56,000 community-based pharmacies in the U.S. Of them, about 7,500 pharmacies offer compounding services. Some estimates say that more than 32,000 pharmaciesin the country offer some kind of compounding. About 40% of people who can compound drugs work in pharmacies that solely compound drugs.

What Are the Different Kinds of Compounded Medicines?

There are two kinds of medicinesmade at compounding pharmacies.

  • Sterile compoundsare drugs that are injected into your tissueor blood, or put into your eyes. They have a higher risk for contamination than traditional pharmacies.
  • Non-sterile compounds come in capsules, creams, and ointments.

Compounding pharmacies have to use pure, pharmaceutical-grade ingredients when they mix up a compounded drug. These must be made at a facility that’s registered with the FDA.

There are differences in how compound and traditional drugs are labeled, too. Compounded medicine labels don’t follow a format like FDA-approved drugs do. They aren’t regulated the same, either.

Are There Different Types of Compounding Pharmacies?

There are two types of compounding pharmacies:

503A compounding pharmacies. They can create a medication for you based on your doctor’s prescription. The compoundingcan’t be done by someone under supervision of a pharmacist. They’re mostly managed by the states.

503B compounding pharmacies. These are outsourcing facilities, which can make a medicine based off a prescription. They can also create large amounts of medicines and sell them to medical offices. The FDAmanages most of these. They have stricter labeling rules than 503A pharmacies in an effort to avoid confusion.

What Governs Compounded Drugs and Compounding Pharmacies?

Although the FDA has approved the medicines used in a compounding pharmacy, it doesn’t approve compounded drugs like they do with traditional prescription drugs, such as the dosages The FDA can’t confirmif a compounded drug is safe or effective the way that they do with manufactured drugs.

State pharmacy boards manage compounding pharmacies in the U.S. But the FDA can oversee the safetyof drugs used in compounding. The Drug EnforcementAdministration (DEA) can do the same for controlled substances that are put into compounded drugs. Federaland state authorities can manage the labs and equipment used, too.

Compounded drugs have to follow industry standards, and the United States Pharmacopeia (USP) Convention sets those. If they’re made in an outsourcing facility, they have to followgood manufacturing practice (CGMP) rules that cover how they’re made, processed, and packed.

In addition to licensed doctors, a licensed pharmacist, or someone supervised by one, can create a compounded drug.

They can be made in a pharmacy or outsourcing facility. The FDAand state pharmacy boards can inspect those facilities.

Do Compounding Pharmacists Have Education in Making Custom Medicines?

Pharmacists learn how to make their own versions of medicines in pharmacy school. Many states test how well they can compound before they get their license.

Many that work in compounding pharmacies have advanced training in compounding. States don’t require specific training, though. There’s no national specialty in drug compounding.

For example, pharmacists can earn a designation as a board-certified sterile compounding pharmacist (BCSCP). This means they meet standards for safety when preparing sterile compounded medications.

Why Would I Need to Use a Compounded Drug?

If the medicine you need isn’t available in a premade form from a manufacturer, your health care professional might prescribe a compounded drug.

Pharmacists can mix a drugto:

  • Customize the dosage
  • Add flavor (for a child or pet)
  • Change the form (perhaps from pill to liquid)
  • Remove allergens or non-essential ingredients

If you’re concerned about taking a compounded drug, talk to yourdoctor. They may be able to tell if you’re better off on a compounded drug or if a traditional prescription will benefit you. This conversation could be important because a traditional drug may be just as effective -- and it'll probably be cheaper, too.

What Types of Drugs Are Compounded Most Often?

Some drugs are more commonly prescribed in compounded form. These include medicines for:

  • Pain: Like baclofen, bupivacaine, cyclobenzaprine, diclofenac, flurbiprofen, gabapentin, ketamine, and lidocaine.
  • Hormone replacement: Including, estradiol, estriol, progesterone, and testosterone.
  • Dermatology: Doctors often combine different drugs to treat skin-related conditions.
  • Animals: It’s commonfor doctors to prescribe compounded medications for animals and pets.

Compounding pharmacies can be handy when there are drug shortagesas well. The pharmacists can essentially make the same formulations as a manufactured drug.

Why Can Compounding Drugs Be Risky?

Some compoundingpharmacies and drug preparers may make misleading statements about the safety or efficacy of compounded drugs. They may not follow standards as with traditional, FDA-approved drugs.

If the mixture is contaminated, it can injure or kill people. This happened in 2012 when the New England Compounding Center (NEC) sent out compounded a methylprednisolone acetate solution free of preservatives. It contained fungus that caused 753 infections and 63 deaths.

Be aware about purchasing something from out of state because some states don't have rules that are as strict as others in terms of quality.

Do Compounded Drugs Cost More Than Manufactured Drugs?

There’s limited data to show price differences between compounded drugs compared to traditional, manufactured drugs.

In 2012, the average cost for an ingredient in a compounded drug was $308.49, while ingredients in non-compounded drugs were $148.75. There was a 130.3% increase in the average ingredient cost for compounded drugs from 2012 to 2013. On the flip side, costs for non-compounded drug ingredients went up 7.7% during that time.

Check with your insurance plan to see how they may cover a compounded drug. They may cover it differently compared to manufactured drug. And you may want to know what they'll pay before you fill the prescription to avoid any unexpected costs.

How Can I Find a Compounding Pharmacy Near Me?

To find a compounding pharmacy near you (or one that may be able to mail you the prescription if you're in a different state), visit the Alliancefor Pharmacy Compounding search tool. The Pharmacy Compounding Accreditation Board has a search function as well. You can see which compounding pharmacies are accredited by the Pharmacy Compounding Accreditation Board.

What Is a Compounding Pharmacy? (2024)


What Is a Compounding Pharmacy? ›

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.

What is compounding pharmacy explanation? ›

Traditional compounding is the preparation of a medication to meet the prescriber's exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient.

Are compounded semaglutide safe? ›

Are there concerns with compounded semaglutide? FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient.

What is the difference between a compounding pharmacist and a regular pharmacist? ›

While both have graduated from pharmacy school and are licensed to fill prescriptions written by your practitioner, compounding pharmacists have received additional extensive education and training in the specialized art and science of compounding.

Is compounding pharmacy legitimate? ›

That means many people with legitimate prescriptions from their doctors were unable to get them, except through a compounding pharmacy. Properly compounded versions are legal for anyone with a prescription, says Scott Brunner, CEO of Alliance for Pharmacy Compounding (APC), an advocacy organization.

How do you explain compounding? ›

Compounding is a powerful investing concept that involves earning returns on both your original investment and on returns you received previously. For compounding to work, you need to reinvest your returns back into your account. For example, you invest $1,000 and earn a 6% rate of return.

Are compounded meds safe? ›

Some compounding pharmacies and drug preparers may make misleading statements about the safety or efficacy of compounded drugs. They may not follow standards as with traditional, FDA-approved drugs. If the mixture is contaminated, it can injure or kill people.

What is the dark side of semaglutide? ›

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Does compounded semaglutide work as well as Ozempic? ›

Compound Semaglutides.

This type of injectable works the same as Ozempic and WeGovy but can be purchased at fraction of the cost. This compounded semaglutide can be tailored to fit individual needs and tolerances based on your doctor's specifications.

How much weight can you lose with compounded semaglutide? ›

It typically takes about 17 weeks to reach your final maintenance dose of semaglutide. Studies show that, on average, adults using semaglutide lost about 35 pounds—about 15% of their body weight. In contrast, 31% of people using a placebo lost about 6 pounds, or about 2.5% of their body weight.

Does Medicare cover compounded drugs? ›

Compounded Drugs

Compounded medications created by a pharmacist in accordance with the Federal Food, Drug and Cosmetic Act may be covered under Medicare.

Do compounding pharmacies make pills? ›

503B compounding pharmacies: These pharmacies, too, can compound medications based on a prescription. But they can also compound sterile medications in large amounts and sell them to healthcare locations, such as hospitals or doctor's offices. These are also sometimes called “outsourcing facilities”.

Is a pharmacist higher than a doctor? ›

Trained to do different things

By contrast, physicians get four years of post-graduate education plus three to seven years of residency. Included in this is some 12,000–16,000 hours of clinical training—which is, at minimum, more than six times as much as what pharmacists get.

What is the problem with compounded semaglutide? ›

Compounded semaglutide-like products have not been evaluated for safety, quality and efficacy by us. You should use caution when purchasing medicines from unknown websites, as these medicines: may contain undisclosed and potentially harmful ingredients.

What are the disadvantages of compounding pharmacy? ›

The disadvantages are the cost, time to make the product, potentially poor-quality products, drug dosing miscalculations, the use of specialized equipment, and non-reporting of adverse effects to the FDA. Compounding medications may pose a public health risk if they are not created properly.

Is semaglutide the same as Ozempic? ›

What is Ozempic? Ozempic, known generically as semaglutide, was approved in 2017 by the U.S. Food and Drug Administration (FDA) for use in adults with type 2 diabetes. Ozempic is a weekly injection that helps lower blood sugar by helping the pancreas make more insulin.

What is an example of drug compounding? ›

An HCP may create a compounded medication if you need a certain combination of drugs that isn't available commercially. An example of this is a compounded topical cream for treatment-resistant neuropathic pain that includes: amitriptyline. baclofen.

Why are compounded drugs not FDA approved? ›

However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality. Compounded drugs should only be used to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.

What is the difference between a specialty pharmacy and a compounding pharmacy? ›

A compounding pharmacy is a specialty pharmacy in that they provide medication in a form, dosage or combination not commercially available.

What is the difference between medication and compounding? ›

The medications used in compounding formulas, when broken down, are virtually identical from a chemical perspective. The only real difference is that compounding pharmacies combine the ingredients in-house to meet the individual patient's needs.

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