The Rx Report

July 2024

WELCOME

In this edition of the Rx Report, we’re sharing the latest news on: 

  • The FDA’s New DDC Rule
  • New USP Guidelines
  • New Facility Expansion Update
  • Our New Pharmacy Management System & More

Thank you for choosing TMC as your trusted compounding pharmacy!

TMC Insights

Facility Expansion & New MGMT System

Compliance Updates

New USP Standards & Guidelines

Announcements

Health Observances & Product Spotlight

INDUSTRY UPDATES

FDA Proposes 'Demonstrably Difficult to Compound' Rule

On March 20, 2024, the FDA proposed a new rule to establish criteria for certain drug products or categories that present “Demonstrable Difficulties for Compouding” (DDC lists). This rule aims to identify and prohibit compounding of specific drug products by 503A compounding pharmacies and 503B outsourcing facilities.

The criteria for inclusion on the DDC lists include complex formulation, drug delivery mechanisms, dosage forms, bioavailability, compounding processes, and testing complexities. The initialdrug categories proposed for inclusion are oral solid modified-release drugproducts, liposome drug products, and those using hot-melt extrusion. This move is seen as an expansion of FDA’s regulatory oversight in pharmacy compounding. It is important to note, while none of Tailor Made Compounding’s current products are affected by this proposed rule, the FDA plans to use this framework to evaluate whether additional products or categories of products will be considered demonstrably difficult to compound in the future. Regrettably, this could end up including products commonly compounded and dispensed by your pharmacy, such as hormones. We will continue to remain vigilant and committed to compliance with all regulatory updates.

Click Here to Learn More.

New USP Guidelines

In compliance with the new USP Beyond Use Date (BUD) limitations, Tailor Made Compounding continues to implement updated USP BUD guidelines for all compounded sterile preparations. Following our phased approach, we have now updated the BUD for several additional products:

  • Pentosan Polysulfate Sodium 250mg/mL 5/mL: Maximum BUD is now 60 days for batches compounded after 3/31/2024
  • Testosterone Cypionate (GSO) 200mg/mL 10mL, 5mL, 4mL, 2mL: Maximum BUD is now 90 days for batches compounded after 5/31/2025
  • Semorelin 2000mcg/mL 7.5mL: Maximum BUD will update to 90 days forthcoming.

Please adjust prescribing protocols and inform patients accordingly. Be on the lookout for the future updates on other sterile products.

TMC INSIGHTS

New Facility Expansion Update

We are delighted to share the latest progress on our new state-of-the-art 20,000+ square foot facility expansion. As of June 2024, the construction is nearly complete, with the exterior almost complete and the interior specs taking shape. This expansion will significantly enhance our compounding capabilities, allowing us to increase productions capacity, streamline workflows, and introduce new technologies.

Our commitment to quality and compliance remains unwavering, with the new facility designed to exceed current regulatory standards. The facility is on track to be fully operational by Fall 2024, and we look forward to the opportunities this expansion will bring. Thank you for your continued support as we take this significant step forward in our mission to provide the highest quality compounded medications.

New Pharmacy Management System Coming Soon

We are excited to update you on the progress of our transition to a cutting-edge pharmacy management system. This system will enhance our operational efficiency, streamline processes, and support compliance with all federal and state regulations. As we prepare for the implementation,  we are conducting thorough testing and training to ensure a seamless transition.

This upgrade will improve our collaboration with clinic prescribing solutions, enabling us to better serve our patients and clinic partners. We look forward to providing  you with a more efficient and integrated service experience. Stay tuned for more details  as we move closer to the system’s launch.

ANNOUNCEMENTS

TRIO ADVANCED

Made with kakadu plum extract to help brighten, firm, and nourish skin.

Pharmacist-formulated with:

  • GHK-Cu
  • Argireline
  • Leuphasyl
  • Kakadu Plum Extract

JULY 1-31

UV SAFETY
MONTH
 

JULY 21

Gastroparesis Awareness Month

JULY 22

HEALTHY
AGING
MONTH

All Tailor Made Compounding branded Cosmetics and Dietary Supplements are sourced, manufactured, labeled, and packaged by third party contract FDA registered CGMP Manufacturers. These products are not compounded by the Pharmacy.