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While recent news about shortages and FDA rulings can raise a lot of questions, here at Shed, we’re dedicated to continuing to provide access to your medications along with updates on current events. 

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To start off, what exactly is a compounded medication? 

While you may have heard the term many times, what is the actual difference between a compounded medication and a commercially available one?

A compounded medication is a drug that is formulated specifically to meet the needs of a specific patient. These medications are made in a licensed compounding pharmacy. Compounded medications are made by mixing, altering, or combining ingredients to create a new medication that is not commercially available in the exact version or dosage prescribed for the patient.

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Compounded medications and shortages

Previous shortages made it possible for compounding pharmacies to compound medications like tirzepatide and semaglutide, making the medications more accessible to patients through telehealth clinics. With recent FDA rulings and decisions, some of these clinics may lose access to these compound medications due to updated regulations that may affect their partner pharmacies’ ability to produce them.

Fortunately for Shed, we partner with both 503A and 503B pharmacies, which allows us to continue providing these medications as long as a licensed provider deems it medically necessary to prescribe them to their patients.

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503A pharmacy vs. a 503B pharmacy

A 503A pharmacy is regulated by state boards of pharmacy and can compound medications only after a licensed healthcare professional determines a need for it for their patient and prescribes it specifically for that individual. These pharmacies are ideal for patient-specific needs.

Just to be clear, they are not allowed to make copies of commercially available drugs unless there is a documented medical need as determined by a provider. 

A 503B pharmacy is registered with and regulated by the FDA. It must follow strict Current Good Manufacturing Practices (cGMP). A 503B pharmacy is able to make compounded medications in bulk, allowing it to help fill the needs of clinics and hospitals. In turn, this means it cannot make patient-specific formulations based on a provider’s determination. 

Because 503B pharmacies are FDA-regulated, they face limitations when it comes to commercially available drugs, specifically when they are no longer on the shortage list.

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Why our members still have access

At Shed, we’ve partnered with both 503A and 503B pharmacies, allowing us to be flexible and remain compliant as FDA regulations evolve. This continues to set us apart from other telehealth clinics. If a provider sees a legitimate medical necessity to prescribe a compounded medication, access to that medication is available through our 503A pharmacies. 

Shed members can feel at ease, knowing their access is not changing and we’ll continue to connect you with providers to determine the right treatment plan specifically for you. Through our pharmacy partnerships, you can feel confident that your medications are sourced responsibly and within regulatory guidelines. Shed embraces scrutiny with our pharmacy partnerships. We will continue to be proactive when it comes to regulations and keep you informed of any important updates. We believe that patients should not be the ones to suffer when systems change.

While we do not promote nor recommend specific medications, we will connect you with a provider which will help you determine what is medically right for you. We’ll provide you with support every step of the way.