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Your guide to compounded medications

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Cheerful pharmacist working in a compounding pharmacyIt’s no secret that some, even many, lines of prescribed medication supply have encountered bottlenecks and breakdowns recently. This has led to shortages at the distribution point and caused many pharmacists to disappoint their patients holding the prescriptions unless the pharmacy has facilities to dispense compounded medications. 

The problem was reported to Congress in May 2023, when an investigation by the Department of Health and Human Services reported that “prescription drug shortages are an ongoing concern in the US.”

The report highlights some of the most impactful effects of drug shortages:

  • Consumers in older age brackets are significantly affected by drug shortages. Two-thirds of those that suffered a failure in the supply of their drugs were 45 and older.
  • Drug shortages leave consumers unable to fill their prescriptions. The prescription was often never filled, even after supplies were restored. The study found a decline in sales volume of between 28% and 35% year-on-year after a drug shortage was corrected.
  • Drug shortages have led to higher prices, especially for generic substitutes. The data showed a 16% increase in the prices of the generic alternatives to drugs in shortage.

This article highlights how an element of the drug supply chain has suddenly come back into action, the element of compounding pharmacies – where drugs are produced in a local pharmacy to satisfy single orders instead of waiting for supplies to be delivered from a central point when there are shortages or breakdowns.

How compounding pharmacies went out of the picture 

Back in the earlier half of the twentieth century, people would have been quite familiar with the concept of a pharmacist (or druggist, or even apothecary) that filled out prescriptions by mixing ingredients from a large store of raw chemicals and compounds in the back and dispensed compounded medications. 

Fast forward to the present, and most pharmacies only have shelves from which they draw manufactured and packaged drugs, pretty much the same way that supermarket shelves carry dry goods. In this scenario, the pharmacist fills a prescription by pulling the relevant bottle or box off the shelf and giving appropriate instructions and guidance to the customer. 

But given the widespread shortages of many essential prescription drugs, compounding pharmacies can play a different role by fulfilling prescriptions like apothecaries did years ago – by mixing ingredients to match the specific requirement set out in a prescription. 

The evolution from compounding to retail pharmacies

Row of vintage apothecary's bottlesThe switch from apothecaries to modern pharmacies mirrors the general economic revolution. In earlier times, a local apothecary was a staple of the community. They were responsible not only for distributing prescribed medicine but also for its production. Druggists of the early 20th century were essential members of their communities, offering a crucial service with a personalized touch. Each prescription was meticulously prepared on-site, often with raw ingredients found only on the apothecary’s shelves. These professionals had a deep knowledge of botanical and mineral substances, carefully combining these in the precise mixtures needed to produce the required remedies. The relationship between druggists and their customers was grounded in trust and personal understanding.

Today, there is primarily a standardized, supply-driven model in modern pharmacies. This shift reveals significant changes in healthcare practices, manufacturing advances, and new social norms. It came parallel to the shift from corner grocery stores and retail shops on the street level to supermarkets and chain stores in giant malls.

Scientific advances, especially in medicine, played a pivotal role in drug production and distribution evolution throughout the 20th century. It produced a convergence of several streams, including advancements in treatments with drugs, changes in legislation, and shifts in public health services. As the application of drugs burgeoned, the focus was on developing and testing drugs, necessitating the features of mass production. 

The legislation also contributed to this transformation, passing key laws that impose stricter control on the manufacture and sale of drugs. These laws propelled the pharmaceutical industry towards mass production, gradually reducing the role of the local apothecary in the process.

Some other more significant social shifts drove the change toward modern pharmacies. Urbanization and the rise of consumerism favored convenience and accessibility over personal interaction. Doctors increasingly relied on the medications produced by “big pharma” because they felt their patients would benefit from the greater consistency in dosage and efficacy. Depending on the individual apothecary’s skills and ingredients, locally compounded drugs could vary in strength and quality. 

Standardized medications eliminated variability, providing doctors and patients with reliable treatments and predictable outcomes. Large-scale drug production also made medications more affordable, with increased availability. This made it easier for doctors to prescribe medications and patients to obtain them, improving the overall healthcare delivery system. The drug companies also promoted their products directly to doctors, providing extensive information about their products. This commercial influence should be considered in understanding why doctors transitioned to pre-packaged medications.

Welcoming back compounding pharmacies 

Pharmacy CompoundingModern pharmacies of the 21st century represent a fundamentally different model compared to those from 100 or even 50 years ago. Today’s pharmacists, while still knowledgeable health professionals, are primarily dispensers of packaged medications. This evolution undeniably enhanced the accessibility and consistency of drug quality. Drug stores have also broadened their range to offer medications and a wide variety of health and wellness products. 

The switch from the personalized, hands-on practice of compounding pharmacists to the standardized, supply-driven model of modern pharmacies is a testament to the impact of technological advancements, legal frameworks, and social changes on healthcare. However, before getting lost in appreciation for the convenience and efficiency of the change to retail drug stores, it’s worthwhile remembering that the craftsmanship and holistic approach of compounding pharmacies, supplying personalized care, still has a great deal going for it in connection to addressing the problems of drug shortages.

What can compounding pharmacies offer right now?

Probably the most sought-after medications that have come under severe shortages are two that have become the “gold medals” for people looking to lose weight. As we wrote here and here, there has been a “happenstance” discovery that some of the latest treatments for the control of diabetes have a parallel effect of inducing rapid weight loss. In particular, Ozempic and Mounjaro are among the leaders, thanks to their proven ability to help obese patients shed excess weight quickly and safely. Both of them are in tremendous demand, and supplies haven’t been able to keep up, so their general availability has dwindled to a trickle.

The essential cause of these shortages stems comes from the fact that initially planned production capacity for such drugs was based on the primary market, which was to treat type II diabetes. Until recently, type II diabetes most often developed in people over 45, but it’s been increasing in children, teens, and young adults.

Statistics show that around 35 million Americans have diabetes (about 10% of the total population), and it made perfect sense for the production planners to factor that number in as a cap on likely demand. 

However, a comparison with the number of people who are overweight or clinically obese is startling! According to a Harvard University study, nearly one-quarter of all adults in the US are overweight (defined as having a Body Mass Index between 25 and 28), and a further one-third are clinically obese (with a BMI above 28). That is why the demand from people looking for drugs like Ozempic or Mounjaro has swamped the original market of diabetic meds.

Since the demand for the two drugs has overwhelmed production capacity, local compounding pharmacies are increasingly stepping in to fill the gap. This is for more people than just those seeking a new weight-loss treatment. Many sufferers of diabetes have been unable to get their hands on what is for them an essential medication. In many cases, diabetics who have been using Ozempic for more than four or five years suddenly find supplies out of reach since Ozempic use has been split to meet the much larger weight-loss demand.

How do compounding pharmacies work?

Drugs like Ozempic and Mounjaro as proprietary products are protected by patents. That means no other company can manufacture or sell products with the same ingredients for the first several years after the drug is approved. In Ozempic, the “secret” ingredient is semaglutide; for Mounjaro, tirzepatide. As indicated by the “-tide” suffix, these are similar substances based on glucagon-like peptide 1 (GLP-1) receptor agonists.

Although Novo Nordisk and Eli Lilly and Company have sole rights to the respective finished products, nothing stops a qualified pharmacist from using some of the same ingredients incorporated into the drugs. So, by taking semaglutide or tirzepatide and adding another ingredient (most often one of the B vitamins), they turn it into a product that can be dispensed against a prescription. In this process, compounding pharmacies are not infringing on the patent. What they can’t do is produce their version as compounded medications and sell it in bulk. Each sale must be backed up with a prescription from a healthcare professional.

In the case of Mounjaro, dubbed the “King Kong of weight-loss drugs,” IsraelPharm offers the compounded Titzepatide of the same FDA-approved medication with the addition of Vitamin B6 (pyridoxine). For Ozempic, we can supply compounded Semaglutide, which works in exactly the same way as the branded drug.

The following Q&A is an overview and summary of the FDA’s official view concerning compounding pharmacies.

Who can compound drugs?

Federal law allows for compounding by a licensed pharmacist in a state-licensed pharmacy or federal facility or by a physician. Compounding most commonly occurs in pharmacies. 

What is compounding? 

Drug compounding consists of mixing two or more substances by combining, mixing, or altering ingredients to create a medication that meets the specification of the prescription needs of an individual patient. The end product consisting of compounded medications is not FDA-approved.

Why do some patients need compounded medications?

A compounding pharmacy can help a customer who, for some reason, cannot be treated with standard FDA-approved medication. Examples are patients who have an allergy to an ingredient incorporated in the standard product or a person who cannot swallow a tablet or capsule and needs the same medicine in liquid or injectable form. Compounding, in such cases, serves a vital patient need. 

Does FDA approve compounded drugs?

The FDA cannot verify the safety or effectiveness of compounded drugs, so compounded drugs are not FDA-approved. This means customers should rely on the known levels of safety, effectiveness, and quality of service that the compounding pharmacy has shown. 

Are there risks associated with compounded drugs?

Compounded drugs can fill the gaps in the supply of essential medical needs of patients. However, they do not carry the same assurance of guarantee of safety, quality, and effectiveness as drugs from the factory. The only way to manage any risks is to trust a compounding pharmacy with a strong service history to its customers.

Who inspects facilities that compound drugs?

Generally, each US state has a pharmacy board responsible for overseeing state-licensed pharmacies that produce compounded medications, including a compounding pharmacy’s activity. Some pharmacies are registered with the FDA as outsourcing facilities, and the FDA conducts surveillance and inspection for them.   

What quality standards apply to compounded drugs?

The quality requirements for compounded drugs can differ depending on where the compounding occurs. When a state-licensed physician or pharmacist compounds drugs, they are exempt from compliance with current good manufacturing practice (CGMP). This means they are subject to the quality standards set in the home state’s law or policy, which may differ from state to state.

However, other federal requirements apply regardless of where compounding occurs, whether in a pharmacy or a physician’s office. Most essential is that the compounded drugs can only be supplied under the same dispensing terms as those applying to all ingredients. This means that if any ingredient requires an authorizing prescription, the compounded drug also requires the same.

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