Healthcare is constantly evolving, and unexpected challenges can emerge with these changes, like the scarcity of semaglutide. At MediVera Compounding Pharmacy™ , we understand the importance of easy prescribing, a quick practice-specific drug catalog, and straightforward payment solutions. Our commitment to you and your patients remains steadfast as we stand by your side to address semaglutide shortages.
Why Semaglutide Matters
Semaglutide has emerged as a transformative medication in recent times. Initially developed to regulate blood glucose levels in patients with diabetes, its journey didn’t stop there. In 2021, commercially manufactured semaglutide gained FDA approval as a weight loss medication, extending its horizon to tackle obesity.
Semaglutide Shortages: The Current Scenario
Challenges are inherent in any healthcare journey, and semaglutide is no exception. Due to ongoing commercial shortages of semaglutide, healthcare providers may find it challenging to secure adequate supplies for their patients. MediVera Compounding Pharmacy™ is committed to supporting healthcare providers in navigating these challenges.
Pharmacy Compounding: A Vital Element of Healthcare
In the American healthcare system, pharmacy compounding has emerged as an indispensable thread. Skilled pharmacists create custom medications tailored to individual patient prescriptions, addressing specific needs that manufactured drugs may not fulfill. While manufactured drugs are essential, they may not always offer the diverse strengths and dosage forms necessary for every patient. Healthcare providers have the flexibility to prescribe compounded medications when they determine that a manufactured drug is not the optimal solution for a patient, whether human or animal.
It’s vital to clarify that compounded drugs are far from being “knock-offs,” as some media portray them. Instead, they are legitimate therapies crafted from pure bulk ingredients by pharmacies that adhere to the rigorous compounding standards of the US Pharmacopeia. State boards of pharmacy license these pharmacies and they are subject to inspections by both these state boards and the FDA.
When dispensing a compounded medication, a healthcare professional—a doctor, physician’s assistant, nurse practitioner, or veterinarian—has thoughtfully prescribed it. Compounded drugs are not substitutions for FDA-approved drugs. Healthcare professionals prescribe compounded medications when a customized dosage strength, form, or combination is most suitable for the patient’s need.
Healthcare providers believe that compounded medications make up approximately 1% to 3% of all prescriptions written in the U.S. Chances are that you or someone you know has benefited from a compounded drug, whether for personal health or the well-being of a beloved pet.
What Medications Can Be Compounded?
Federal law sets criteria for active pharmaceutical ingredients eligible for use in compounded human-health medications. To be considered for compounding, an active pharmaceutical ingredient must:
- Be a component of an FDA-approved drug product.
- Have an applicable USP or National Formulary monograph.
- Appear on the 503A Bulks List published by the FDA.
Additionally, federal law generally prohibits the compounding of a medication that is a direct copy of an FDA-approved drug, unless the drug appears on the FDA drug shortage list.
Semaglutide Shortages: A Current Concern
Recent months have witnessed semaglutide-based medications listed as “currently in shortage” on the FDA drug shortage list. This development has triggered discussions in the media and regulatory attention from state boards of pharmacy, entities that govern traditional compounding pharmacies. Unfortunately, some media reports and state board communications have contained inaccuracies.
Contrary to certain state board communications, FDA-approved semaglutide drugs remain “currently in shortage” on the FDA’s official list. “Currently in shortage” doesn’t imply that the drug is entirely unavailable; it simply means there might not be sufficient supply to meet the demand. FDA has issued guidance confirming that when a drug is listed as “currently in shortage,” it may be compounded.
Semaglutide Sodium or Semaglutide Acetate
There is disagreement on the eligibility for compounding semaglutide sodium or semaglutide acetate. While it doesn’t meet the criteria established by the FDA, some compounders argue that the science supports its use, as semaglutide sodium is a more chemically stable and water-soluble form of semaglutide. However, the FDA states,
“The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.”
Therefore, MediVera Compounding Pharmacy™ does not use the salt forms of semaglutide.
Pharmacy Compounding vs. Sketchy Sellers
The distinction between pharmacy compounding and dubious online entities is crucial. Legitimate compounding pharmacies source active pharmaceutical ingredients (API) from FDA-registered and -inspected manufacturers. This API comes with a certificate of analysis that documents the substance’s identity, potency, and purity. Patients and prescribers need to verify the legitimacy of sellers when obtaining compounded medications.
Compounding pharmacies are an essential aspect of healthcare, and they become all the more critical during drug shortages like the semaglutide shortage. Compounded medications must adhere to stringent standards and comply with federal law. Patients and prescribers can seek added assurance through a certificate of analysis, which documents the composition of the dispensed medication.
Do not conflate the media’s portrayal of purported semaglutide sales via sketchy online entities with legitimate pharmacy compounding. Patients should avoid buying substances purported to be semaglutide from non-pharmacy online sellers. Only through a licensed prescriber and a licensed U.S. pharmacy can patients access legally compounded semaglutide.
Navigating Semaglutide Shortages with MediVera Compounding Pharmacy™
We understand that a reliable partner is essential. At MediVera Compounding Pharmacy™ , we’re dedicated to mitigating the impact of semaglutide shortages on your practice and your patients. Our Impressed Advantage by MediVera Compounding Pharmacy™ is your assurance of quick responses, on-time deliveries, and an easy prescription submission process.
The Impressed Advantage by MediVera Compounding Pharmacy™
- Impressed Doctor: Reclaim your time without prior authorizations and patient education resources.
- Impressed Patient: 94% customer satisfaction, patients contacted within 1-business day of receiving confirmation, and shipping within 48 hours of patient confirmation.
- Peace of Mind: Our dual PCAB accreditation signifies our commitment, with a monthly investment of $30,000 dedicated to enhancing patient safety.
- Committed Team: Practice support by an account manager, five full-time pharmacists, and trained pharmacy technicians.
As pharmacy compounding evolves in the face of challenges like the semaglutide shortage, it remains a vital component of healthcare, providing customized solutions when traditional drugs fall short. Your trust in the compounding process is a cornerstone of our commitment to your well-being. We prioritize your health and your patients’ needs. With our expertise, dedication, and unwavering professionalism, we strive to provide informed, factual, and caring support. At MediVera Compounding Pharmacy™ , we assist one patient at a time in living their best life.
For more information on obtaining a prescription or prescribing compounded semaglutide from MediVera Compounding Pharmacy™ , visit our weight loss management page.
Disclaimer: This article is intended for informational purposes only and is not written by a physician. It should not be construed as medical advice. Always consult a healthcare professional for any medical concerns or before starting any new treatment. Please note that compounded medications are prepared under specific conditions and should be prescribed by qualified healthcare professionals to ensure appropriate use.
