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Are Compounded Drugs Safe?

Nancy L. Belcher

Medically reviewed by Nancy L. Belcher Ph.D, MPA

Written by Winona Editorial Team

Last updated November 25, 2021

Are Compounded Drugs Safe?

Compounding Medications Questions and Answers

What are compounded medications?

When people talk about compounded drugs, what that means at Winona is the process of combining, mixing, or altering ingredients to create a medication that is prescribed by a licensed physician and mixed by licensed pharmacists to the needs of an individual patient. Compounding medications creates a specific medication that is tailored to meet the specific needs of Winona patients starting with FDA-approved products (estrogen or progesterone from yams).  

When Winona makes drugs in their pharmacy that are compounded they start with two or more drugs that are FDA approved. Because the FDA cannot oversee every compounding pharmacy in the US, and watch how they actually mix these different drugs, compounded drugs are not FDA-approved. That does not mean that they are not safe, at Winona they are. Winona starts only with FDA-approved medications and mixes them at prescribed levels in a base cream to create custom products for our patients.

Why do some patients need compounded drugs?

There are many reasons that a person might want to use compounded drugs. A lot of medicines are produced on a mass scale, and pharmacies just buy them from wholesalers,  but do not meet the particular needs of most patients.

At Winona, our licensed physicians, scientists, and pharmacists use the latest and most advanced techniques in compounding to provide patients with treatments that they deserve. Winona suggests our patients use compounding creams because they are:

  1. Personalized Medication: Compounding can provide patients with the exact amount of prescription medication needed to relieve their symptoms. Off the shelf, over-the-counter medicines are produced in standard dosages, but not compounded creams - at Winona, you work with your Winona physician directly to identify the most accurate dosage that works best for you.

  2. Convenient: Compounded creams are easy to apply, and can combine multiple medicines into one compounded cream. This way, patients may prevent the possibility of skipping or forgetting medicine.

  3. Less Medication: Compounded creams provide the opportunity to have the drugs absorbed directly through your skin (transdermal) so you don’t have to take more medication than needed.

    When you take medication as a tablet or pill, you swallow it, it goes into your blood and your liver gets the first look at it (called the first pass). The liver tries hard to get all the ‘garbage’ out of your blood and often sees medication as garbage and filters out as much as it can. So, doctors have to overprescribe when they give oral medication to get an effective medicine level to your body after that ‘first pass.’

  4. Allergies: A drug may be compounded for a patient who has an allergy. Compounding is designed to meet every patient’s medical needs. 

  5. Ease of Use: Some people cannot swallow a tablet or capsule and need medicine in a liquid or cream form. 

  6. Cost: Winona’s compounding pharmacies have access to pure, premium medical-grade chemicals and FDA-approved medicine that often has lower costs. This makes compounded medicines less expensive than commercialized drugs. Without the cost of patenting and expensive drug components, compounded medications are significantly cheaper.

  7. Quality Assurances: Our Winona compounding pharmacies ensure high-quality, yet affordable personalized medication and work directly with your Winona physician to ensure your satisfaction. 

    For all of these reasons, compounding can provide an important patient need. Winona provides the highest level of compounding and is proud of their pharmacies’ decades of unblemished experience providing patients with the care they deserve. It is unfortunate that some compounders engage in activities that undermine the drug approval process by making false and misleading statements, but our Winona pharmacies are completely professional and reputable.

What are the risks associated with compounded drugs?

Compounded drugs can serve an important medical need for patients even though the FDA does not verify the safety, effectiveness, or quality. Some pharmacies have engaged in poor compounding practices that have resulted in drug quality problems, such as a drug that contains too little or too much of an active ingredient.

There is no need to worry about this with the licensed, inspected, and accredited Winona pharmacies. Additionally, none of the medications made in the Winona compounding pharmacy are ingested or injected. The transdermal application of compounded creams is the safest way to provide compounded medications.

Who can compound drugs?

Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, as prescribed by a physician, and under the direct supervision of a licensed pharmacist.

Who inspects facilities that compound drugs?

Facilities are inspected by the state boards of pharmacy and FDA. State boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with the FDA as outsourcing facilities. FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities.

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Conclusion:

With over 150 years combined pharmaceutical experience and over 40 years experience as an independent pharmacy, Winona's compounding pharmacy is providing patients with compounding medications of the highest quality and gives you the most convenient, safest, and least expensive options possible.

*Winona can provide a receipt for you to file with your insurance company and takes HSA and FSA accounts.

“This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment.”

References: 

  1. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

  2. https://carolinapharmacy.com/7-benefits-of-an-independent-compounding-pharmacy/#iLightbox[gallery2963]/0