We are excited to introduce The Rx Report, TMC’s official newsletter designed to help you provide your patients with the best care possible by bringing you the latest research and expert insights in medicine.
With each edition, we’ll share industry news, company updates, educational events, FDA regulatory changes, new product announcements, and much more to keep you informed.
Thank you for choosing TMC as your trusted compounding pharmacy!
Starting November 1st, 2023, new revisions for USP chapters <795> and <797> will go into effect. A couple of the most significant changes impacting providers include Beyond-Use Date limitations and batch size restrictions. It is important to note that each state board of pharmacy will determine whether to adopt the new USP revisions (in whole or in part) and if so, when to enforce an implementation timeline. We want to ensure that you and your team understand these new standards and their impact on your practice. As the landscape of compounding pharmacy continues to evolve, you can count on us to keep you informed as November approaches.
**Beyond-Use Date Limitations: BUDs reduced from 180 days to 90 days for compounded sterile products (Slide 14).
**Batch Size Restrictions: Maximum proposed batch size is now 250 vials (Slide 16).
At Tailor Made Compounding, we understand the importance of providing alternative solutions, especially during drug shortages that may negatively impact patient outcomes. Currently, commercially available semaglutide products are listed on the FDA Drug Shortage website – with limited availability projected through December 2023.
As a reminder, the FDA states that if a drug is listed as “currently in shortage,” it may be compounded. Both commercial products containing semaglutide have been on the drug shortage list since March of 2022 – 18 months in which patients have had limited access to these FDA-approved medications prescribed by their physicians. Fortunately, compounding pharmacies offer a solution by temporarily compounding semaglutide to meet demand, facilitating the continuation of uninterrupted patient care.
The FDA allows compounding of drugs on shortage to ensure patients have continued access to medications that, in their prescriber’s judgment, are necessary for continuity of care. Once removed from the shortage list, compounding pharmacies will have no basis to compound semaglutide and will transition to only offering commercial products containing semaglutide. In the interim, compounding pharmacies may step up as providers for patients in need of these essential therapies.
While we anticipate an update from the FDA regarding this matter by the end of December, we remain dedicated to upholding our standards of care and patient safety by adhering to these guidelines.
For more information, please find additional resources linked below:
As a result of our growth in recent years, we are pleased to announce that Tailor Made Compounding is expanding its facilities to include approximately 20,000 square feet. This investment signifies our commitment to precision compounding, elevated quality control, and increased compounding capacity.
While our business grows, our dedication to personalized care remains. The expanded facility will provide an innovation hub for our pharmacists, complete with cutting-edge sterile and non-sterile cleanrooms and industry-leading compounding equipment to ensure the unique needs of your patients are always met.
This progress would not be possible without the support of our prescribers. We thank you for your invaluable commitment to providing patients with exceptional health care.