Drug Compounding in Pharmacies

Uses, Benefits, and Risks of Uniquely Formatted Medications

Compounding phamacist placing prepared pills in bottle
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Drug compounding is a service provided by some pharmacies and is a process in which medications are prepared in unique formulations for a specific patient. These formulations can sometimes be very important in meeting a patient's needs, such as when a person is allergic to an inactive ingredient found in commercially available forms of the medication. At the same time, it's important to understand that while the individual drugs included in the formulations are approved, the special formulations aren't FDA approved for safety or efficacy. Once the standard of care, as all medications were formulated by "chemists" at one time, the requests for compounded medications have rebounded and these personalized formulations are in increasing demand.

Basics of Drug Compounding

Compounded drugs are medications that are prepared according to a unique recipe that combines, mixes, or alters ingredients in order to meet a particular patient's needs. Or, in more detail:

U.S Pharmacopeia Convention Formal Definition of Compounding

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.

Compounded drugs may be used when an FDA-approved medication is unsuitable for a patient's needs, such as when a person has an allergy to a component of the commercially available medication or requires a custom dose or method of delivery.

Most often, a physician will provide the recipe and a compounding pharmacist will check the recipe against standard drug information for accuracy.

Uses and Examples

There are a number of reasons why a physician and/or pharmacist may recommend a compounded drug, with some being the only way a person can receive a needed medication, and others being personal preference alone.

Different Form or Method of Delivery

A common reason for compounding drugs is to provide a form and method of delivery that will work for a particular patient. For example, young children and elderly adults may have difficulty swallowing pills. If the commercial medication is only available in pill form, a compounding pharmacist may provide the same drug in liquid form.

Similarly, some people are unable to take oral medications due to digestive conditions that interfere with absorption. In this case, the compounding pharmacist may provide the drug as a suppository or transdermal gel.

With topical medications, a doctor may recommend that a particular drug that is only available as a cream be formulated as an ointment, gel, or lotion (and vice versa) as each of these formulations may have different effects.

Custom Strength or Dose

When a medication is only available in a few strengths or doses, drug compounding may be recommended to create a unique dose. For example, infants and children, especially those who are premature, may need extremely small doses of medications. An example is preterm infants who have acid reflux.

To Combine Medications

Sometimes a compounding pharmacist may create a unique capsule containing different drugs a patient uses to limit the number of pills she is required to take.

Allergies and Intolerances to Components of FDA-Approved Drugs

Most prescription medications, over-the-counter medications, and nutritional supplements contain inactive or inert ingredients in addition to the active ingredients. Referred to as excipients in medications, these ingredients are added for a number of reasons such as for color (food dyes), as binders, as preservatives, and more.

While inactive as a drug, people can have allergies or intolerances to these ingredients. Examples include some food dyes (tartrazine or FD&C yellow #5), lactose (in people who have lactose intolerance), wheat, barley, or rye derivatives (in people who have celiac sprue or gluten sensitivity), cornstarch (in people who have a corn allergy), and more.

In these cases, the compounding pharmacist can prepare the drug without the nonessential ingredient.

It's important, however, to make sure there isn't an alternative FDA-approved medication without the offending ingredient.

For example, the thyroid replacement drug Synthroid may cause allergies or sensitivities in people who have lactose intolerance (it contains lactose), corn allergy (it contains cornstarch), or acacia allergy (some people who have tree and grass pollen allergies), but there is another brand of levothyroxine (Tirosint) that does not contain these ingredients.

Medications that Aren't Readily Available Commercially

A very important role of compounding pharmacies is the preparation of a needed medication when the FDA-approved drug is in short supply. This may be even more critical if a patient requires a drug that a pharmaceutical company decided to stop making due to lack of profit from the drug.

Bioidentical Hormone Replacement

Bioidentical hormone replacement is essentially compound hormone replacement therapy with another name. The thought that hormone replacement should be personalized for each woman based on her levels on lab testing is commendable, but we don't currently have evidence-based findings to back up this practice.

Flavoring

Not as great as an issue as a lack of access to commercially available drugs, taste can occasionally make a difference as to whether children will take their medication or not. Compounding pharmacists can change the ingredients so that flavor is added, or unpleasant flavor is withheld.

Safety and Regulation

Pharmacy compounding is regulated on a state-by-state basis (by state boards of pharmacy), but standards set by the United States Pharmacopeia (USP) are also integrated into the practice of drug compounding. Pharmacies that compound a large volume of drugs can be accredited through national standards developed by The Pharmacy Compounding Accreditation Board (PCAB).

While the FDA does not regulate compounded drugs, it does oversee the safety of the drugs used as ingredients in these formulations (called active pharmaceutical ingredients (APIs)). In addition, the DEA oversees any controlled substances that are used in the formulations.

People may wonder why the FDA doesn't have more oversight of compounded drugs, but since these drugs are typically made individually for each person, regulation of each product made is simply not practical or feasible. That said, new policies have been introduced regarding compounded drugs, and more are currently being considered.

For those who are interested in learning more, section 503A and section 503B of the Federal Food, Drug, and Cosmetic Act go into the details about current policy.

Pharmacist Training and Resources

Special training for pharmacists is not required as pharmacists are taught in school how to compound medications, but many who work in specialty compounding pharmacies have undergone formalized training such as the Professional Compounding Centers of America (PCCA) Comprehensive Compounding Course or Aseptic Training Course.

Pharmacists also have resources available where they can check on recipes for commonly compounded medications such as the PCCA and Lexi Comp. Community pharmacists can also contact specialty compounding pharmacies for help. And certainly, pharmacists can speak with the physician who wrote the prescription with any questions.

Safety Concerns

There have been several illnesses and deaths related to compounded drugs. An outbreak of fungal meningitis in 2012—related to a contaminated injectable steroid produced by New England Compounding Center in Massachusetts—led to the Compounding Quality Act of 2012. In this outbreak, 750 people were affected in 20 states, and 60 people died. There were many problems found with the pharmacy upon review, including the issue that compounding pharmacies cannot legally distribute medications (as they did).

A 2017 article published in The New England Journal of Medicine notes that further illnesses and deaths have occurred since that time, and since compounding pharmacies don't have to report adverse events to the FDA (as with FDA-approved medications), it's likely there are more that have not been reported. A few of the concerns that have been raised while investigating compounding pharmacies have included unsanitary conditions where the drugs are prepared and the formatting of drugs without evidence-based information supporting their use (such as intravenous injection of an herbal product).

At the same time, however, it's clear that compounded drugs can serve people's needs (and are sometimes the only option available) in a way that mass-produced drugs cannot. Overall it's thought that higher production standards are needed so that compounding pharmacies can continue to fulfill the needs of individuals who require these drugs.

Benefits and Risks

As with any medication you use, whether prescription, over-the-counter or nutritional supplements, it's important to weigh the benefits and risks for you personally.

Benefits

The benefit to a compounded drug is that it may meet your specific needs in a way that a mass-produced product cannot.

In some cases, the benefits of a compounded drug are very clear, such as needing a life-saving drug that is in short supply or otherwise unavailable. At other times, the benefit may not be as clear at all.

It's important to consider how important using a compounded drug may be for you and your health.

Risks

The potential risks associated with a compounded drug may include:

  • A drug that has too little or too much of the active ingredient if it is poorly formulated
  • Contamination during preparation
  • Lack of effectiveness due to the makeup of the formulation (for example, inactive ingredients can affect how rapidly and how much of a drug is absorbed)

Cost can be a consideration as well, with compounded drugs often (but not always) more expensive than mass-produced drugs. Insurance coverage may also vary.

Finding Compounded Medications

A little over 10 percent of pharmacies specialize in compounding services but many communities and hospital pharmacies do compounding as well. Specialty pharmacies, however, are more likely to prepare sterile formulations for injection.

Questions to Ask Your Doctor or Pharmacist

If your doctor has recommended (or if you've heard of and have thought of requesting) a compounded medication, there are a few questions you can ask before and after filling the prescription.

  • Is there an FDA approved drug that will meet your needs instead?
  • Is the compounding pharmacy accredited? (If the answer is no it's not necessarily a reason not to choose the pharmacy or a guarantee of a good product, but may give you some comfort in your choice).
  • Is the pharmacist comfortable creating the formulation?
  • Are the directions clearly written on the label?
  • Are there any special storage requirements, such as the need for refrigeration?

A Word From Verywell

In an era when personalized or precision medicine is becoming the key to getting optimal treatment, the option of having drugs specially formulated to meet your needs—instead of the one-size-fits-all approach of mass-produced pharmaceuticals—may be enticing. But it's important to understand both the potential benefits and risks associated with any compounded drug and to weigh the balance with the information available today.

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