The Rx Report

December 2023

WELCOME

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

  • 503A Category 2 Bulk Drug List Updates
  • “Reasons for Compounding” requirements
  • New USP Standards & Guidelines
  • Construction Progress of Our New Facility
  • Where to Find Us In Vegas This Month at the A4M Longevity Fest


Thank you for choosing TMC as your trusted compounding pharmacy!

TMC Insights

Faster Processing Times are Here!

Compliance Updates

New USP Standards & Guidelines

Upcoming Events

Conferences & Special Occasions

Faster Processing Times

We are pleased to announce that our processing times have improved significantly, with the capacity to dispense, package, and ship an order in as few as 5 business days.

COMPLIANCE & REGULATORY UPDATES

503A Category 2 Bulk Drug List Updates

On Friday September 29th, 2023, the FDA updated the 503A Category 2 Bulk Drug Substance list to to include a number of peptide substances.

Under Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA approved drug, must have a USP or NF monograph, or must appear on FDA’s 503A Bulks List or Interim Bulks List Category 1. While the peptide substances listed in Category 2 have never met those criteria for compounding, all doubt has been removed with FDA placing them on Category 2.

TMC recognizes the newly added bulk substances have never met the requirements eligible for compounding, which is why we have spent the last few years dedicated to providing long-term, sustainable options. Keep in mind, TMC still offers peptides and alternative options, such as
Sermorelin/Glycine, among others.

TMC maintains its commitment to being at the forefront of innovation, continuously researching and developing new products that adhere to the strictest regulatory guidelines. We remain dedicated to providing our customers with the latest, highest quality compounded medications, while always prioritizing compliance with applicable state and federal regulations.

“Reasons for Compounding” Requirements

As a 503A compounding pharmacy, FDA and state pharmacy boards prohibit compounding pharmacies from dispensing a compounded product which is deemed an “essential copy” of a commercially available drug. To comply with FDA guidance and state laws regarding “essential copies” of commercially available drugs, providers prescribing a compounded version of a commercially available drug must notate on the prescription why the compounded version produces a significant difference, as determined by the provider, for the specific patient for which the prescription was written.

If a prescription is received without a valid reason for compounding, we will immediately put the prescription on hold. Before processing the prescription. one of our pharmacists must contact the prescriber to confirm the compounded product produces a significant difference for the patient before processing the prescription.

We are here to help answer any questions you have regarding “reasons for compounding” requirements. Please contact your Account Manager if you have any questions or concerns.

New USP Standards and Guidelines Update

As mentioned in our last RX Report, Tailor Made Compounding is in the process of implementing the revised USP <795> and <797> compounding guidelines which were made official on November 1, 2023. It is important to note that each state board of pharmacy will determine whether to adopt the USP revisions (in whole or in part). and when to enforce them. In general, states in the process of adopting new USP guidelines are providing an implementation period to allow compounding pharmacies sufficient time to train staff and operationalize the updated guidelines.

TMC is in the process of updating our standard operating procedures (SOPs). Upon completion of the SOP updates, we will provide comprehensive training to relevant employees on the revised policies and procedures. Examples of some of the heightened requirements under new USP include stricter garbing practices, increased environmental monitoring practices, shortened beyond-use dates (BUD), and reduced batch sizes.

As the landscape of compounding pharmacy perpetually evolves, you can count on us to keep you informed.

TMC INSIGHTS

New Facility Update

We are thrilled to share a quick update on our ongoing building expansion project. Since breaking ground, we have witnessed remarkable progress. The new 20,000+ square foot facility is well on its way to completion. Our target is to have it fully operational by late summer of 2024. This expansion reflects our commitment to enhancing our capabilities and serving you even better. We look forward to the opportunities this brings and are excited to share more as we continue to grow.

UPCOMING EVENTS

A4M LONGEVITY FEST 2023

DECEMBER 14 - 16
LAS VEGAS, NV

We hope to see you there!

Drop by our booth: #3085

DECEMBER 1

WORLD
AIDS DAY

DECEMBER 1-7

CROHN'S & COLITIS
AWARENESS WEEK

DECEMBER 5-9

NATIONAL FLU
VACCINE WEEK