What Are Compounded Medications?

Compounded medications are specially prepared by pharmacists or physicians to meet unique patient needs. Unlike mass-produced drugs, compounded medications are customized by combining, mixing, or altering ingredients to create a medication that is tailored specifically for you. These medications can come in various forms, such as creams, gels, liquids, or capsules, to suit individual requirements.

FDA Approval and Regulation

It’s true that compounded medications are not FDA-approved like commercially manufactured drugs. However, this does not mean they are unsafe. Compounded medications are regulated by state pharmacy boards and must adhere to stringent standards set by the United States Pharmacopeia (USP). These standards ensure that compounded medications are prepared with high-quality ingredients and under proper conditions to maintain their safety and efficacy.

In addition to state regulations, the Drug Quality and Security Act (DQSA) of 2013 introduced outsourcing facilities that can compound medications in bulk. These facilities are subject to FDA oversight and must comply with Current Good Manufacturing Practice (CGMP) requirements, similar to those for pharmaceutical manufacturers, to ensure the highest standards of quality and safety.

Why Choose Compounded Medications?

Compounded medications offer several benefits, especially when standard medications do not meet your needs. For example:

• Allergies: If you are allergic to an ingredient in a commercially available drug, a compounded medication can be formulated without that allergen.
• Dosage Forms: If you have difficulty swallowing pills, a compounded medication can be made into a liquid or topical form.
• Specific Strengths: Sometimes, the exact dosage you need is not available in a commercial product. Compounded medications can be tailored to provide the precise strength you require.
• Pediatric and Veterinary Needs: Children and pets often require medications in specific forms or flavors to ensure they take them as needed.
• Drug Shortages: Compounded medications can be a solution when there is a shortage of brand-name medications, ensuring you still receive the treatment you need.
• Cost-Effectiveness: Compounded medications can be more cost-effective, especially for patients without insurance, providing affordable access to necessary treatments.

A Common Example of Compounded Medication

One common example of a compounded medication is a hormone replacement therapy (HRT) cream. Many patients, particularly those undergoing menopause, require specific hormone dosages that are not available in standard commercial products. A compounding pharmacy can create a personalized HRT cream that delivers the exact hormone levels needed, improving the patient’s comfort and health outcomes.

Ensuring Your Safety

While the media and some manufacturing companies may raise concerns about compounded medications, it is important to understand that reputable compounding pharmacies follow rigorous standards to ensure your safety. Pharmacists who compound medications are highly trained professionals who adhere to strict protocols to maintain the integrity and quality of the medications they prepare.

We always choose a compounding pharmacy that is accredited and follows the best practices in compounding.

Compounded medications provide a valuable, personalized solution for patients with specific health needs. While they are not FDA-approved, they are regulated and must meet high standards of quality and safety. By working with a reputable compounding pharmacy, you can be confident that you are receiving a medication that is tailored to your unique needs and prepared with the utmost care.

If you have any questions or concerns about compounded medications, speak with our providers or pharmacists.  We are here to ensure you have the safest and most effective treatment options available.