What Changing USP Guidelines Mean for You

What's Changed with USP Guidelines?

The USP recently implemented updated guidelines for both sterile and nonsterile compounded medications.

The implementation dates for these changes vary by state, which is why telemedicine patients may have different experiences depending on where they live.

All compounding pharmacies will eventually update to these standards.

Let’s go over what the relevant changes encompass.

Beyond-Use Dating (BUD)

USP enacted stricter limitations on how long compounded medications remain stable and safe for use. The Beyond Use Date (BUD) is essentially the medication’s expiration date.

This change has impacted patients since BUD is an important factor in how medications are shipped.

Pharmacies cannot ship more medication to patients than can be used within the medication’s BUD window. Because those timelines are now shorter, pharmacies will ship less medication to patients per order, and patients will likely have to order more frequently.

Storage and Shipping Requirements

USP enhanced its requirements for storing and shipping temperature-sensitive medications. These new guidelines aim to make sure medications remain stable from the time they’re created to when they’re delivered to the patient.

This is another change that has a direct impact on patients. Some medications now ship with different requirements, including overnight shipping on ice packs. This will change the shipping cost for affected patients.

Environmental Control

USP enhanced its requirements for air quality, temperature, and humidity monitoring in compounding facilities to ensure medication stability and sterility.

This change may cause delays as pharmacies update their facilities and processes to meet the new requirements.

Personnel Training and Competency

USP now requires more rigorous ongoing training and assessments for pharmacy staff involved in compounding operations.

Patients may notice changes or delays while compounding pharmacies adapt their operations to align with the updated regulations.

Quality Assurance and Testing

To ensure quality, the USP guidelines have expanded documentation requirements and quality control procedures. It also requires more in-depth testing, especially for injectable medications.

This may extend the production schedule for medications, which means medications may reach patients more slowly as pharmacies update their processes.

Facility Design and Equipment

USP updated its requirements for cleanroom environments, particularly for sterile compounding. This includes more frequent environmental monitoring and certification.

This may impact the length of time it takes for a medication to be produced, thus extending the time it takes for patients to receive medications.

Varied Implementation of USP Guidelines

Another layer of complexity is that states and pharmacies are each responding to the USP updates differently.

Some states have different deadlines for implementation. In addition, some of the language in the updates is vague, leading to different interpretations across pharmacies.

Each pharmacy is working at its own pace to update their processes. Defy Medical expects greater consistency once all pharmacies fully align with the new guidelines.

All compounding pharmacies must update to the new USP guidelines eventually. Clinics may claim to have access to unaffected compounding pharmacies, but that is not true under USP regulations.

How This Affects Your Care at Defy Medical

Defy Medical thoroughly vets its Pharmacy Partners to ensure they maintain high safety and efficacy standards. As such, many of Defy Medical’s Pharmacy Partners are at the forefront of adjusting processes to meet USP guidelines.

Defy Medical Has Not Changed

While our patients are impacted by these changes, Defy Medical has not changed any internal procedures or treatment approaches. These updates are being adopted by the pharmacies with whom we partner.

Defy Medical has no control over BUD lengths, medication production, pharmacy processing, and shipping. We cannot solve pharmacy delays or have medication produced more quickly.

We have an expansive pharmacy network so we can offer alternative solutions in the event of a shortage or delay (when available). If your medication is delayed or on shortage, our team may be able to offer alternatives to avoid an interruption in your care.

Our goal is to keep patients informed as pharmacy practices evolve, and to help minimize potential disruptions to patient care. We are in active communication with all our Pharmacy Partners to understand how each is implementing these changes.