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 US. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding. Please continue reading to find out more about human drug compounding and compounded medications.

What does it mean when a pharmacy is compounding?

When you say a pharmacy is compounding, it essentially means that the pharmacy is making a compounded drug from scratch. In other words, while most pharmacies simply dispense pre-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 keep active pharmaceutical ingredients in stock and mix them according to a patient’s needs to make a compounded medication.

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.

What can compounding pharmacies do?

Here are a few examples of situations in which a compounding pharmacist can make customized compounded medications to meet a patient’s 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.
When 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 some patients require a flavoring to be added to a medication to make it more palatable.
If person needs a drug that is currently in short supply.
In case a person needs a drug that has been discontinued.

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

Why did my doctor prescribe compounded drugs?

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

Allergies

Your 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 a 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 all together, 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 of 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 can help with 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 are the risks of getting a 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.

Who regulates compounding pharmacies?

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

Compounded medications are made according to standards developed by the United States Pharmacopeial (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.

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.

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.

Wrapping Up: What is the difference between a compound pharmacy and a regular pharmacy?

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.

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