By Jerry Meloche, Pharm.D. Owner / Compounding Pharmacist, Creative Scripts Compounding Pharmacy
If you’ve recently noticed changes in your compounded medications, whether it’s a different formulation, a shorter expiration date, or an increase in price—you’re not alone. Recent updates to pharmacy compounding standards have introduced new regulations that impact how these medications are prepared, stored, and dispensed. Many patients are only now feeling the effects of these changes as state boards of pharmacy begin enforcing the new rules.
Why Are These Changes Happening?
Compounding pharmacies play a critical role in providing personalized medications for patients who need alternatives to commercially available drugs. To ensure the highest quality and safety standards, the United States Pharmacopeia (USP) periodically updates its guidelines. As of November 1, 2023, three key USP chapters—795, 797, and 800—were revised, introducing stricter requirements for non-sterile and sterile compounded medications, as well as those classified as hazardous drugs. However, enforcement was delayed in many states until November 1, 2024, giving pharmacies time to implement the necessary changes. Now, as enforcement ramps up, patients are seeing the effects firsthand.
Key Regulatory Changes and Their Impact on Patients
1. USP 800: Hazardous Drug Handling
Certain commonly compounded medications—such as hormones, antifungals, immunosuppressants, and dermatological creams—are now classified as hazardous drugs. As a result, compounding pharmacies must handle these medications in specialized laboratory spaces with stringent safety measures, including:
• Dedicated, ventilated areas for hazardous drug preparation
• Additional protective equipment for pharmacists and staff
• Strict documentation and monitoring protocols
Because of these requirements, some compounding pharmacies may no longer be able to prepare certain medications, and those that do may need to increase pricing to cover the costs of compliance.
2. USP 797: Sterile Compounding Updates
Sterile compounded medications—such as injectable drugs, eye drops, and IV formulations—must now be prepared under stricter environmental controls. This includes:
• More rigorous air and surface testing to prevent contamination
• Comprehensive staff training and ongoing evaluations to ensure sterile technique
• Enhanced quality control measures to reduce the risk of errors
These upgrades increase operational costs for pharmacies, which may lead to higher prices for patients. However, the benefit is a reduced risk of contamination and improved medication safety.
3. USP 795: Non-Sterile Compounding Updates
For non-sterile compounded medications—such as topical creams and oral suspensions—new guidelines focus on beyond-use dates (BUDs), which are similar to expiration dates. Key changes include:
• Shorter beyond-use dates for medications containing any water activity, unless costly stability testing is conducted
• A shift toward anhydrous (water-free) compounding bases to extend BUDs and comply with regulations
If your compounded cream or suspension has a new consistency, smell, or texture, it may be due to these formulation changes. While the effectiveness remains the same, your pharmacist can address any concerns you may have.
What This Means for You
The updated compounding regulations aim to enhance safety, quality, and consistency in customized medications. However, patients may experience:
• Changes in formulation – Some medications may have a different base or consistency to comply with regulations.
• Shorter expiration dates – Medications containing water will have reduced beyond-use dates unless additional testing is performed.
• Increased pricing – Compliance with stricter safety protocols requires significant investment in equipment, facilities, and staff training.
• Limited availability – Some pharmacies may discontinue compounding certain medications due to the high cost of compliance.
What Can You Do?
If you have concerns about how these changes affect your prescriptions, talk to your compounding pharmacist. At Creative Scripts Compounding Pharmacy, we are committed to providing personalized care and finding solutions that meet your needs. Whether it’s adjusting your formulation, discussing alternative options, or explaining pricing changes, we are here to help.
Regulatory changes can be frustrating, but they ultimately aim to ensure the highest quality and safety in compounding pharmacy. By staying informed and working closely with your pharmacist, you can continue to receive the customized medications that support your health and well-being.
Creative Scripts Compounding Pharmacy custom builds medication, one patient at a time. We use the highest quality pharmaceutical-grade ingredients, state-of-the-art bases, equipment, and technology. Continual training on the newest techniques, advances in therapy, and regulations allows our pharmacists and technicians to provide the safest, most effective medications for you AND your pets. In addition to compounded medications, we offer pharmaceutical-grade nutritional supplements, health advice, and hormone consults. Creative Scripts specializes in veterinary compounding, dermatology, bio-identical hormone replacement therapy (BHRT), pain management, and more. Pharmacists Jerry and Lisa Meloche have served Naples and surrounding communities since 2005.
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Creative Scripts Compounding Pharmacy
239-261-0050
600 Goodlette Road North #108
Naples, FL 34102
www.creativescripts.net