What Are Compounded Medications
Compounded medications are custom-made prescription drugs that a pharmacist prepares by combining, mixing, or altering ingredients to create a medication tailored to an individual patient’s needs. These medications are typically made when commercially available drugs do not meet a patient's specific requirements.
Reasons for Compounded Medications:
- Dosage Customization: A patient may require a dosage strength that is not commercially available.
- Alternative Forms: Some patients struggle with swallowing pills, so a pharmacist can create a liquid, cream, or sublingual formulation.
- Allergy-Free Formulas: Commercial medications may contain dyes, preservatives, gluten, or lactose that some patients cannot tolerate. Compounding allows these ingredients to be removed.
- Discontinued Medications: If a pharmaceutical manufacturer discontinues a drug, a compounding pharmacy can replicate it.
- Combination Medications: Some conditions require multiple medications that can be combined into a single dose for convenience.
- During Medication Shortages: Compounding pharmacies step in to fill gaps in the supply chain by creating medications that meet patients' needs when FDA-approved versions are in short supply or temporarily unavailable.
Commonly Compounded Medications:
- Hormone Replacement Therapy (HRT): Customized bioidentical hormone treatments.
- Pain Management: Topical creams, gels, or transdermal patches for chronic pain.
- Pediatric Medications: Custom-flavored liquid versions of drugs.
- Veterinary Medications: Special formulations for pets.
- Dermatology: Acne treatments, anti-aging creams, and wound care formulations.
Examples of Compounded Medications During Shortages
- Semaglutide & Tirzepatide (Ozempic®, Wegovy®, Mounjaro®) – Due to weight loss and diabetes treatment demand, compounding pharmacies have provided versions of these GLP-1 receptor agonists.
- Adderall (for ADHD) – When Adderall shortages occurred, some compounding pharmacies created customized versions.
- IV Fluids & Electrolytes – Hospitals sometimes rely on compounding pharmacies when pre-made solutions are scarce.
- Pain Medications – Shortages of certain opioids and anesthetics have led to compounded alternatives.
Are Compounded Medications Safe?
Factors That Influence Safety
- Pharmacy & Pharmacist Expertise
- Medications should be compounded by a licensed and experienced pharmacist.
- Accredited compounding pharmacies (e.g., those certified by the Pharmacy Compounding Accreditation Board – PCAB) follow strict quality and safety standards.
- Quality of Ingredients
- High-quality ingredients from reputable manufacturers ensure safety and effectiveness.
- Some lower-quality suppliers may produce inconsistent or contaminated products.
- Sterile vs. Non-Sterile Compounding
- Sterile compounding (for injectables, eye drops, etc.) requires special cleanroom facilities and strict protocols to prevent contamination.
- Non-sterile compounding (creams, capsules, liquids) still follows strict guidelines but does not require the same level of sterility.
- FDA Oversight & Regulations
- The FDA does not approve compounded medications like mass-produced drugs.
- However, the U.S. Pharmacopeia (USP) sets standards for safety and quality (e.g., USP 795, USP 797, and USP 800).
- Compounding pharmacies may be inspected by state pharmacy boards and the FDA.
Compounded medications play a crucial role in personalized medicine and drug shortage solutions. If you require a compounded medication, ensure you work with a reputable, accredited compounding pharmacy and consult with your healthcare provider to determine the best option for your needs.