A regular retail pharmacy sells drugs that are made by a pharmaceutical company. A compounding pharmacy is one that makes its own drugs from a group of chemical ingredients. Compounding pharmacies play an important role in American medicine but can be riskier to use than a regular retail pharmacy. Compounding pharmacies account for about 3% of prescription drugs sold in the United States. Some of the reasons physicians may utilize a compound pharmacy are:
- An FDA-approved drug is not available in the best form for a patient. This is a common problem, for example, a patient cannot swallow pills and a certain medication is only available from pharmaceutical companies in pill form. In this case, the compounding pharmacy may create the medication in liquid form for that specific patient. Another common reason for compounding is to make put a drug in an ointment or cream for a dermatologic indication.
- A drug needs flavoring for a child. Often, children won’t swallow medication if it tastes bad. A compounding pharmacy can often make the same medication with a fruit flavoring or sweetener added to it.
- An FDA-approved drug has an inert ingredient that a patient is allergic to. I had this problem with a patient who was allergic to a dye used in the tablets of a certain drug. A compound pharmacy was able to make the same medication with no dye added.
- A patient needs a dosage that is not in commercially available pills or capsules. In this case, the compounding pharmacy can create a customized dose of a drug in a capsule for a patient.
- Consolidating multiple medications into one dose. For example, if a patient needs to take 3 different medications every day, the compounding pharmacy may be able to create one capsule containing all three drugs to simplify administration and improve patient compliance.
- An FDA-approved drug is no longer being manufactured commercially. This can happen if the demand for a specific drug falls so that it is no longer financially profitable for a pharmaceutical company to continue manufacturing it.
- Your pet needs a drug. Many medications used in humans are also used in dogs and cats. But that pet may require a different dose than is available for humans or may need the drug in a different form to administer to the animal.
- A commercially available drug is on the FDA’s drug shortages list. When pharmaceutical companies are unable to manufacture enough of an FDA-approved drug to meet market demand, compounding pharmacies are allowed to make equivalent medications. This can happen because the pharmaceutical company has not ramped up production sufficiently or because there is a problem with the manufacturing facility (such as a fire or hurricane damage to the facility).
Many regular retail pharmacies will offer compounding services for simple compounding, such as converting a medication in capsule form into a liquid form. I have frequently had local pharmacies do this for patients with G-tubes who cannot take medications by mouth and can only take them in a liquid form through the feeding tube. But recently, there have been on-line compounding pharmacies that make copies of brand name drugs and often have their own employed physician who will prescribe the compounded drug over the internet to the patient.
Let the buyer beware…
The biggest risk to using a compounding pharmacy is that the compounded drug that they sell is not FDA-approved and the FDA does not have oversight to the mixing process or the labeling. Therefore, there can be issues with the drug’s purity, safety, or effectiveness. For example, in 2012, the New England Compounding Center produced a form of methylprednisolone for epidural injection that was contaminated with a fungus. 798 people developed fungal meningitis from Exserohilum rostratum and Aspergillus fumigatus. 64 of these infected patients died. Last year, tirzepatide produced by a compounding pharmacy was found to be contaminated by bacteria (tirzepatide is the chemical name for the commercially available drugs Monjaro and Zepbound).
Compounded drugs are not always as potent as the FDA-approved brand name drug. For example, in 2023, it was found that some compounding pharmacies making semaglutide (the chemical in the brand named drug, Wegovy) were using semaglutide sodium and semaglutide acetate which are salts of semaglutide that have not been proven safe or effective. Sometimes compounded drugs may come in different concentrations than the brand name drug, creating the possibility that patients can miscalculate and accidentally take too much or too little of a dose.
The problem with on-line compounding pharmacies
Currently, there are a lot of television ads for Hims.com, an on-line compounding pharmacy that advertised during the Super Bowl. Companies such as this allow people to enter some basic medical information on-line and then a prescriber working for the company can order compounded versions of drugs for conditions such as weight loss, erectile dysfunction, anxiety, and hair loss. These compounded drugs are often much cheaper than the commercially-available brand name medications that a person would buy at a retail pharmacy. Also, some people want to avoid the embarrassment associated with discussing their weight or sexual problems with their regular doctor and feel more comfortable with the anonymity of on-line prescribing.
From a treating physician’s standpoint, the biggest problem I have with patients using compounding pharmacies is that I don’t know what drugs the patients are getting. We normally go to great lengths to do “medication reconciliation” to ensure that we have an accurate list of a patient’s medications. Our electronic medical records are where this reconciliation occurs and if we don’t have a medication listed in the electronic medical record, there is no way for us to know if that medication causes dangerous drug interactions with the medications we prescribe or if that medication is responsible for new symptoms that are side effects of that medication. Similarly, the provider working for the on-line compounding pharmacy cannot access our electronic medical record and consequently cannot be sure of what medications I have already prescribed for the patient or what medical conditions I have diagnosed the patient with. The result is that patients can be harmed when information falls through these cracks.
They are not FDA-approved
The compounding pharmacies do not fall under the FDA’s jurisdiction. That means that the FDA has not done independent testing to ensure a compounded drug is safe or that the dose is correct. Instead, compounding pharmacies are licensed and overseen by the department of health of the state that the compounding pharmacy is located in. Every state’s department of health is different – there are different state-specific laws, different degrees of health department staffing, different frequencies of facility inspection, and different degrees of oversight between states. For this reason, there is no way of knowing if an out of state compounding pharmacy is being held to the same standards that it would be if it was in your own state. Like many businesses, compounding pharmacies often gravitate to states with the fewest regulations.
Compounding pharmacies cannot sell a drug under its brand name and instead can only use the drug’s chemical name. Thus, the compound pharmacy will use the chemical name semaglutide but not the brand names Ozempic or Wegovy. The price difference can be dramatic – Wegovy costs just over $5,000 for a 3-month supply without insurance whereas compound pharmacies sell compounded semaglutide for $750 for a 3-months supply on-line.
Importantly, compounded drugs are not generic drugs. The FDA regulates and approves generic drugs that are manufactured by a pharmaceutical company and sold at a lower price than brand name drugs. This typically happens when a drug’s patent expires. Generic drugs are sold in regular retail pharmacies. Since generic drugs are overseen by the FDA, you can be reasonably confident that the drug is pure, it is safe, and the dosage is accurate.
Pharmaceutical companies are angry
To create a drug like Wegovy requires years of research that can cost hundreds of millions of dollars. The United States recognizes this and will grant pharmaceutical companies patents on new drugs for 20 years. This gives the pharmaceutical company 20 years to recoup their research and development cost as well as make a profit. Once that patent expires, other pharmaceutical companies can make and sell generic forms of that medication.
Compounding pharmacies can bypass the patent protection by making copies of a drug when the FDA determines that there is a national shortage of that drug. This can erode the pharmaceutical company’s marketshare of a patented drug and lower profits. Needless to say, pharmaceutical companies want their patented drugs to get off of the FDA’s Drug Shortages List as quickly as possible so that compounding pharmacies cannot produce copies of their drugs. This leads to arguments between the pharmaceutical companies and the compounding pharmacies about whether the pharmaceutical company actually has enough supply of a drug to meet demand. The compounding pharmacies will accuse the pharmaceutical company of underestimating demand and the pharmaceutical companies will accuse the compounding pharmacies of overestimating demand. The FDA then gets caught in the middle trying to make a decision.
Eli Lilly’s drugs Zepbound and Mounjaro were taken off of the FDA’s Drug Shortages List last October and compounding pharmacies then had to stop manufacturing compounded tirzepatide. Last month, the FDA determined that Novo Nordisk’s drugs Ozempic and Wegovy will be taken off of the Drug Shortages List so compounding pharmacies have been given 6 months to stop producing compounded semaglutide. Last week, the Outsourcing Facilities Association, a compounding industry group, filed a lawsuit against the FDA in order to put Ozempic and Wegovy back on the Drug Shortages List so that they can continue to create compounded versions of the drugs.
So, what should physicians tell their patients?
Whenever possible, tell patients to get their medications at a regular retail pharmacy in either brand name or generic form. When compounding cannot be avoided (for example, getting a drug in liquid form that is only commercially available in tablet form), then use a pharmacy that you trust – either a retail pharmacist or a local compounding pharmacy that you are familiar with. Avoid using on-line compounding pharmacies for drugs that patients can otherwise get at their regular retail pharmacy.
This usually is not a problem when a drug is covered by a patient’s health insurance plan – all the patient will be responsible for is a (usually) low co-pay. It can be a problem when a drug is not covered on a patient’s health insurance formulary, if the insurance company will not approve the drug for the patient’s specific condition, or if the patient does not have health insurance. In these cases, the physician needs to weigh the risks and benefits of a compounded drug for the individual patient. On the one hand, there is no guarantee of the compounded drug’s purity or effectiveness. On the other hand, the patient may not be able to afford the drug produced by a pharmaceutical company and sold in a regular retail pharmacy.
The GLP-1 receptor agonist drugs are the quintessential example – most insurance companies will only cover them for diabetes and not for general weight loss indications. For a patient without diabetes who wants to take a GLP-1 drug to lose weight, the annual cost of the drug made by a compounding pharmacy is about $3,000 whereas the annual cost to buy the drug made by a pharmaceutical company is about $20,000. Many patients will accept the risk of the compounded drug since it will cost them $17,000 a year less. From a physician’s perspective, the health risk of untreated obesity may be greater than the risk of the compounded drug.
Most importantly, be sure to get drugs patients acquire from compound pharmacies onto your electronic medical record. This means asking your patients specifically if they are getting medications from on-line pharmacies. The electronic medical record will identify common drug interactions and can prevent serious harm from patients, but only if the drugs patients are actually taking are entered into the EMR. No physician wants to be caught by prescribing nitroglycerin to a patient who has been getting tadalafil (Cialis) from an on-line pharmacy and then having the patient have a cardiac arrest from sudden hypotension cause by the interaction of the two medications.
March 1, 2025
