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Drug Shortages Are a Boon to One Industry: Compounding Pharmacies

Relentless drug shortages are fueling a niche sector that operates outside the realm of the traditional pharmaceutical industry: compounding pharmacies. Large-scale compounders, which make custom versions of medicines in bulk without individual prescriptions, are filling more of the demand for crucial drugs such as pain medications and respiratory treatments, hospitals, pharmacists and industry officials say. Compounding facilities are also supplying more anesthetics, including lidocaine and ketamine hydrochloride. More than half of the 1,100 members of the American Society of Health-System Pharmacists surveyed recently said they increased purchases from large compounders—known as outsourcing…

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Featured

 The weight loss drugs you’re getting may be fake

By purchasing knock-off medications from medical spas or via apps and websites, consumers risk products that are not safe or fit for human consumption.

 Thinking of buying Wegovy online. Here’s what to know about compounding pharmacies

With the growing demand for weight-loss drugs like Wegovy, new online companies seem to pop up every day, offering telehealth prescribing of cheaper, compounded versions of the medicines. And for some patients, they offer a reprieve from the high name-brand prices, insurance company coverage denials and drug shortages. The convenience and cost can be appealing, but there are some risks. Here’s what to know and how to protect yourself. Many of the new websites offering to ship medicine to your door offer compounded versions of popular drugs made in-house or at compounding pharmacies they partner with. Be aware that some companies selling compounded semaglutide may not be in compliance with state and federal standards.

 What You Need to Know About Compounded Versions of Popular Weight Loss Drugs

But as with many situations in which supply far exceeds demand, questionable versions of these drugs are making their way into desperate patients’ hands, and doctors are concerned about what exactly these versions contain. Some online sellers are exploiting the opportunity to cash in, selling knockoffs of Wegovy, whose active ingredient is semaglutide, that may not even contain semaglutide.

Articles of Interest

'Wild west of the drug industry': John Oliver takes on compounding pharmacies

Compounding pharmacies do have an important role, Oliver acknowledged – the nearly 7,500 of them in the United States concoct specialty drugs for a variety of medical needs, such as a liquid medicine for someone who struggles to swallow pills, lower concentration doses than commercially available, and pina colada-flavored medicine for pet parrots.

An Overview of Compounding

Compounded medications may offer therapeutic alternatives for patients with unique medical needs that cannot be met by U.S. Food and Drug Administration (FDA)-approved drugs.

Compounding and the FDA: Questions and Answers

Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.

Compounding is the latest darling of telehealth and Big Tech, but is Silicon Valley prepared for the regulation that comes with it?

Compounding pharmacies must comply with multiple layers of regulations, including portions of the federal Food, Drug & Cosmetic Act (FDCA), state statutes and regulations governing the practice of pharmacy, controlled substance regulations, and compounding standards developed by organizations like the U.S. Pharmacopeia (USP). Regulation is even more nuanced when it comes to compounding medication for animals. As new entrants try to make the most of rapidly changing technology and ever-evolving ways to deliver medical care to patients, it becomes increasingly important to stay apprised of state and federal regulations governing compounding.

Compounding pharmacies are making their own versions of blockbuster weight loss drugs

As more people turn to blockbuster drugs like Wegovy to shed weight, many are considering cheaper alternatives from specialized pharmacies that make custom batches of medicines.

Compounding Pharmacies Feel a Squeeze

As far as compounding pharmacies are concerned, the U.S. Food and Drug Administration is compounding their problems.

Compounding pharmacies offer a fix for shortages of essential drugs

At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need. In a 2021 APC survey, more than 80 pharmacies nationwide reported they had provided compounded versions of those essential drugs to hospitals under the temporary guidance.

Counterfeit Ozempic Crackdown: Drugmakers Threaten Clinics For Compounding Drugs During Shortages

Ozempic and Wegovy manufacturer announced it will take legal action against facilities illegally compounding the drugs amid persistent shortages, which have left some patients without medication.

In a Drug Linked to a Deadly Meningitis Outbreak, a Question of Oversight

The outbreak, with 5 people dead and 30 ill in six states, is thought to have been caused by a steroid drug contaminated by a fungus. The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center. Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration.

John Oliver Explains How Certain Pharmacies Get Away With Fraud and Worse

Compounding pharmacies do the important work of tailoring medications to the needs of a particular patient, but as John Oliver points out on Last Week Tonight, they’re not as regulated as the major drug manufacturing companies, which opens them up to all sorts of problems.

Out-of-Control Compounding of Drugs

Compounded drugs have not gone through the same rigorous tests for safety and effectiveness required of standard drugs and are not made in plants inspected by the F.D.A. to ensure good manufacturing practices. There have been several incidents in recent years in which compounded drugs have caused injury.

Pharmacy Compounding Advisory Committee

The Committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs.

The Role of Pharmaceutical Compounding in Promoting Medication Adherence

Pharmaceutical compounding is an important component of pharmacy practice despite its low prevalence. Several therapeutic needs can be met by a compounded medicine such as dosing adjusted for pediatric patients, special drug combinations, medicines for patients allergic to a given excipient, and medicines for orphan drugs not provided by the pharmaceutical industry. Examples of such applications are provided in this review.

The Source of a Deadly Meningitis Outbreak

The contamination was soon traced to what's known as a compounding pharmacy—specifically the New England Compounding Center in Framingham, Massachusetts. Drugs from the center had been contaminated with fungi and bacteria, which were then injected into patients who developed serious infections.

Resources

Alliance for Pharmacy Compounding

The Alliance for Pharmacy Compounding is the voice for pharmacy compounding, representing compounding pharmacists and technicians in both 503A and 503B settings, as well as prescribers, educators, patients, and suppliers.

International Journal of Pharmaceutical Compounding

The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly scientific & professional journal emphasizing quality pharmaceutical compounding.