You leave your doctor’s office with a diagnosis and a prescription. But the prescription includes special instructions: to fill it at a compounding pharmacy. Wait, what? Where do you find such a place? And what is a compounding pharmacy, anyway?
Don’t be surprised if you are unfamiliar with the term—compared to “regular” pharmacies, dedicated compounding pharmacies are few and far between. Of the 56,000 community pharmacies in the United States a mere 7,500 specialize in compounding services, according to the American Pharmacists Association. Add to that the fact that the majority of prescription medications don’t require compounding and, well, it is entirely feasible that their existence is news to you. If you ever do need a compounding pharmacy, you will need a few details on what they are, what they do, and how to find a good one.
What is a compounding pharmacy?
Basically, a compounding pharmacy—or compound pharmacy—is a pharmacy that makes certain medications from scratch, says Lars Brichta, Pharm.D., director of clinical and scientific affairs for ChemistryRX, a compounding pharmacy in Philadelphia that specializes in medications for skin conditions and rare diseases. However, these pharmacies are anything but basic.
Most pharmacists simply dispense medications that arrive at the pharmacy premade. At compounding pharmacies, the pharmacists actually customize medication for each individual patient and his or her unique needs, as long as that drug is not available from a drug manufacturer. The ingredients are kept on hand, and when a patient needs a particular treatment, a compounding pharmacist mixes it up from these ingredients. For this reason (and others), compound drugs are exempt from FDA-approval, and instead are regulated by state boards of pharmacy based on standards set by the United States Pharmacopeial (USP) Convention. Pills and tablets are not commonly compounded. But, liquids, creams, ointments, lozenges, suppositories, and often capsules are compounded.
Why would I need compound drugs?
If a prescriber sends you to a compounding pharmacy, it might be because:
1. You have allergies.
Many pills contain inactive ingredients that also happen to be possible allergens, such as lactose, gelatin or dyes says Jesica Mills, Pharm.D., owner of Owensboro Family Pharmacy and Wellness in Kentucky. These additives pose a problem for people with certain sensitivities. Compounding can make it possible for them to use the medication without risk of an allergic reaction. “We are able to compound the active ingredient of the medication without any fillers and put it in a liquid form that is free from allergens,” Dr. Mills explains.
2. The prescription is for a child.
Most medications are formulated with adults in mind, and those dosages are usually not appropriate for children (primarily because of their weight), Dr. Mills says. Plus, young children frequently need medication in liquid form because they are unable to swallow pills. Compounding allows a pharmacist to customize dosage forms for a child by making a liquid version of a medication that is normally dispensed in pill form, or to improve the flavor of a medication so a child is more likely to take it easily.
3. The cocktail of pills you need is potentially hazardous.
Cream-based medication for inflammation and nerve or muscle pain management, for example, often contains up to six active ingredients. “If a patient were to take all of these [as] oral medications, there [could] be severe central nervous system depression and it would make us concerned for their ability to maintain lung function,” Dr. Mills explains. “By putting these ingredients in a cream and applying it directly to the [affected] area, we are able to prevent adverse [systemic] side effects of the medicine.”
4. The medication needs customization to meet your medical needs.
If a baby has a staph infection, for example, the treatment is antibiotics added to diaper rash cream. This wouldn’t be appropriate if an infection didn’t accompany the rash, and it is better for everyone involved if the pharmacist does the mixing. “It is not practical to give parents three of four tubes of ointment and expect them to apply them in the right order or all at the same time,” says Dr. Mills, adding that patients usually don’t have the tools or utensils to mix multiple medications at home anyway.
Customization is also typical for topical hormone therapy creams, mouthwash, prescription eye drops, medication and suppositories for hemorrhoids or anal fissures, and transdermal gels/creams/ointments for certain dermatological conditions.
5. The medication is not commercially available.
In rare cases, a patient might need a medication that is not manufactured by a pharmaceutical company and therefore is not a readily available drug for a pharmacist to dispense, says Dr. Brichta. “Sometimes it is not lucrative for a large manufacturer to [make] these medications … but these patients obviously still need their treatments,” he says.
6. Your medication is off-label.
Occasionally, a pharmacist may need to compound a medication for off-label use, Dr. Mills says. This means that it’s prescribed for a condition other than the one it was FDA-approved to treat. Healthcare providers can prescribe such medication, but the dosage might need to be adjusted—hence the need for compounding.
An example, says Dr. Mills says, is Naltrexone, a medication used to treat opioid and alcohol-use disorders that normally comes in a 50 mg tablet. “[Some studies show] that this medication at one to five milligrams [can] help with autoimmune issues,” she says. “Since there isn’t a way to split a 50 mg tablet to get a 3 mg dose, [compounding] pharmacies can order the Naltrexone powder, weigh out [the appropriate amount] and then place it in a capsule for a patient to take.”
How do I find a compounding pharmacy near me?
If your doctor has written a prescription for a compound drug, you must fill it at a compounding pharmacy. Most retail pharmacies offer some level of compounding but “it isn’t heavily advertised due to the small amount of people who need compounded medications,” says Dr. Mills. Depending on the pharmacy services available at your go-to drugstore, you may need to seek out a pharmacy that specializes in compounding.
It is important to make sure that the pharmacy you choose meets certain standards. This can be challenging, Dr. Brichta explains, because compounding pharmacies are not currently required to attain a national certification to dispense compounded drugs . However, they are regularly inspected by their state board of pharmacy to “make sure all the right actions are being taken,” says Dr. Mills. They also have the option to apply for accreditation with the Pharmacy Compounding Accreditation Board (PCAB), a voluntary program that requires adherence to rigorous safety standards. Dr. Brichta urges patients to use PCAB-accredited compounding pharmacies whenever possible.
As for an individual pharmacist’s compounding know-how, Dr. Mills says most licensed pharmacists are trained in at least basic compounding during pharmacy school, and many are required to demonstrate competency in compounding in order to pass the state pharmacy board exams. Pharmacists who wish to specialize in compounding, and work at compounding pharmacies, can do so by taking continuing education classes and additional training, she adds.
Some even choose to focus on sterile compounding, which involves medication that is administered directly into a patient’s vein or eye. These medications need to be compounded in a special sterile lab, because if the medication is contaminated with bacteria it is very risky to the patient (a lot of sterile compounds are administered intravenously, and are therefore only used in hospitals and other medical settings).
So, who regulates compounding pharmacies? While states provide oversight to “traditional” compounding pharmacies, special large-scale sterile labs that ship products between states (or “registered outsourcing facilities”) are regulated by the Food and Drug Administration’s Drug Quality and Security Act. The act was signed into law in 2013 in response to a fungal meningitis outbreak traced to a sterile New England compounding center. The outbreak infected 753 patients, killing 64 of them. The compounder responsible was subsequently sentenced to eight years in prison.
Will my insurance pay for compound drugs?
In response to that outbreak many insurance companies stopped covering compounded drugs Drs. Mills and Brichta say. You’ll need to check your policy for specifics, but it is entirely possible you’ll need to pay out-of-pocket. Unfortunately, the medication can be expensive, Mills says.
“Many of the [compounded] pain creams can cost over $100 per container, so it has really impacted those in lower socioeconomic groups from being able to afford specialized medications,” she says.
Obtaining pre-approval sometimes helps, Dr. Brichta says. ChemistryRX employs two, full-time employees dedicated to helping patients obtain it, but it is no guarantee. “Insurance coverage has become so difficult; it takes a lot of effort,” he says.
The good news? Some compound medications—like omeprazole suspension—have become so popular they can now be purchased commercially, which means you can use your SingleCare pharmacy savings card. To see if your prescription qualifies, check out our price comparison tool or speak with your pharmacist.