Cut the Red Tape: Unlock Patient Access to Vital Compounded Medications

When off-the-shelf is off-the-mark.

Compounding is customized health care, creating medicines for individual patients when a prescriber determines an FDA-approved drug is not appropriate for the patient's specific needs or is not accessible due to a shortage.

What is pharmacy compounding?

In traditional compounding, a pharmacist creates a customized medication, most often from an active pharmaceutical ingredient, for an individual patient based on a prescription from a licensed provider. Pharmacists’ ability to compound medications from pure ingredients is authorized in federal law and FDA guidance in two circumstances:

Appropriate: Manufactured drugs don’t come in strengths and dosage forms that are appropriate for everyone, and providers must be able to prescribe a customized medication when a commercially available FDA-approved drug does not come in a dosage form, strength, or combination the provider judges right for a particular patient.

Accessible: To assure continuity of patient care during a drug shortage, providers may prescribe a compounded copy of an FDA-approved drug when the FDA-approved drug is listed as “currently in shortage” on the FDA Drug Shortages list.

The NASEM Report is troubling, at best

A 2020 FDA-funded report on compounded hormones from the National Academies of Science, Engineering and Medicine recommends across-the-board restrictions on compounded hormones. These restrictions would undermine physicians’ professional judgment and interfere with the practice of medicine, and could prove catastrophic for millions of patients who benefit from those therapies. But that NASEM report is compromised by potential bias, conflicts of interest, and bad science.

Committee members had little to no experience in compounded hormones

Most, if not all, of the NASEM committee members lacked any real-world experience prescribing and dispensing compounded hormones to patients. In essence, the committee was asked to develop recommendations on a topic in which they had little or no expertise.

Explore the NASEM Report's Flaws

"Our compounder provides lifesaving medicine...

Thanks to compounded medications, providing Ozzy emergency relief during his seizures is much faster and easier.”

Who does compounding serve?

Compounding pharmacies routinely create custom medicines for both human and animal patients. They collaborate with physicians, veterinarians, and other prescribers to ensure each patient gets the precise medicine that, in the prescriber’s judgment, the patient needs.

Compounded medications account for an estimated 1% to 3% of all prescriptions written in the U.S. There’s a good chance you know someone who has benefited – or whose pet has benefited – from a compounded drug.

Pharmacy compounding is not big pharma

Some people may think compounding pharmacies are affiliated with the big pharmaceutical companies, but they aren’t.

According to the APC 2023-24 Snapshot of Pharmacy Compounding in America, the typical compounding pharmacy is a small business, based locally, helping provide for patients in their communities. In fact, 88% of compounding pharmacies have only one location, and 61% have fewer than 12 employees. They are committed to the health and safety of their patients, they support the local tax base, and they serve a wide range of patients, both human and animal.

Right now, more than 300 drugs are in shortage in the U.S., denying millions of patients the often life-saving medicines they require. For some of these drugs, compounding pharmacies can fill the gap, preparing copies of the drugs to ensure the continuation of patient care.

A Rigorous Regulatory Framework

Traditional compounded drugs are not knock-offs, “copycats,” or counterfeits. They are legitimate therapies created from FDA-regulated bulk ingredients by pharmacies that adhere to the rigorous compounding standards of the US Pharmacopeia. These pharmacies are licensed by state boards of pharmacy; they are inspected regularly by those state boards and sometimes by the FDA as well. Every one of the active ingredients that compounding pharmacies use must come from FDA-registered facilities and manufacturers. Compounding pharmacies can document the purity and potency of the drugs they prepare based on third-party testing.

Patient stories, in their own words.

What is a compounding pharmacy? How does it differ from a regular pharmacy?

There are two types of compounding pharmacies. Traditional compounding pharmacies make custom, tailored medications and dispense them to individual patients based on a prescription from the patient’s doctor or provider. Outsourcing facilities create compounded medicines in bulk — no prescription required — and distribute them to hospitals and clinics — and for certain drugs, to traditional compounding pharmacies as well.
In both cases, compounding is customized health care, creating medicines for individual patients under two circumstances:

Appropriateness: Manufactured drugs don’t come in strengths and dosage forms that are appropriate for everyone. Providers must be able to prescribe a customized medication when a commercially available FDA-approved drug does not come in a dosage form, strength, or combination the provider judges right for a particular patient.

Accessibility: To assure continuity of patient care when a drug is not accessible, a prescriber may prescribe a compounded version of any FDA-approved drug when the FDA-approved drug appears on the FDA Drug Shortages list.

Traditional compounded drugs are not knock-offs, dupes, or counterfeits. Compounding pharmacies simply create personalized, customized medications and treatments based on qualified prescribers’ orders.

Are compounding pharmacies regulated like regular pharmacies?

Yes, compounding pharmacies are rigorously regulated and inspected; they adhere to the stringent compounding standards of the US Pharmacopeia; they are licensed by state boards of pharmacy, and are inspected by those state boards and often by FDA as well. Every one of the active ingredients that compounding pharmacies use must come from FDA-registered facilities and manufacturers.

What is the turnaround time for compounded prescriptions?

Compounded prescriptions have to be compounded by hand for individual patients. Most compounding pharmacies keep some of the frequently used compounds made in advance so patients can get their medications as quickly as possible. However, some compounds can only be made when a prescriber’s order is placed, which can take longer than simply grabbing pills off a shelf.

Does insurance cover my compound?

It depends. Generally compounding pharmacies have been excluded from insurance networks, which means they typically don’t file your insurance claim directly. In most cases, compounding pharmacies can provide you the information you need to file a claim with your insurance company. The good news is many times compounded medications are in the same price range of a typical insurance copay or generic drug.

Are compounding pharmacies FDA-approved?

The FDA is responsible for approving individual medications, not overseeing pharmacies. Traditional pharmacies and compounding pharmacies are overseen by State Boards of Pharmacy, and compounding pharmacies are governed and overseen by all the same boards and bodies as traditional pharmacies.

The FDA is responsible for regulating manufactured drugs. It does not approve compounded medicines. It is a practical impossibility to trial compounded drugs in the same way that manufactured drugs are tested — how could they since a compounded medicine is created for one unique patient. The critical thing to note, however, is that the lack of FDA approval does not mean a drug is unsafe.

Do medications from compounding pharmacies work?

These medications are carefully formulated and created for each individual patient, which typically provides an even more targeted therapy for the patient. Another benefit of compounding pharmacies is that if the medication doesn’t work as originally prescribed, they can work closely with the patient and prescriber to find the right formulation of their customized medication.

Do compounding pharmacies have a sterile room?

Compounding pharmacies can prepare both sterile and non-sterile compounded medications. Non-sterile dosage forms include topical creams, oral tablets and capsules, and suppositories — essentially, medications used in or on parts of the body where sterility is not necessary for patient safety. Sterile preparations have much stricter compounding standards and requirements to ensure that no microorganisms or other potential contaminants are present. Sterile compounds include ophthalmic solutions, injectables, or parenteral nutrition.

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