The pharmacy world doesn’t slow down and neither do we. In our GameChangers episode, we take a closer look at the most urgent developments on FDA Policy changes. From evolving compounding rules to groundbreaking AI guidance, here’s what’s making headlines and what it means for you and your patients.
GLP-1 Compounding & FDA Policy
As semaglutide and tirzepatide supplies stabilize, the FDA is tightening its stance on compounding. Both medications have been removed from the official shortage list, meaning pharmacies must cease compounding unless strict 503A/503B conditions are met.
What this means for you:
- Prepare for patient transitions off all compounded GLP-1s.
- Stay alert to increased enforcement around unauthorized or telehealth-dispensed products.
- Consider how you’ll guide patients to appropriate access to GLP-1s, when warranted.
Ongoing Drug Shortages
With 270+ active drug shortages across injectables, antibiotics, ADHD meds, and cancer therapies, pharmacists remain on the frontlines of patient care disruptions.
Key insights:
- Supply chain and manufacturing issues continue to drive instability.
- The FDA maintains a public-facing shortage database to track real-time updates.
- Pharmacists are tasked with managing substitutions, counseling patients, and documenting clinical decisions.
Artificial Intelligence in Pharmacy
The FDA policy released draft guidance on AI and machine learning in drug development, regulation, and surveillance. From clinical trial modeling to personalized dosing, AI is set to become an everyday part of practice.
Highlights:
- Focus on transparency, performance monitoring, and data integrity.
- Applications include decision support, dosing algorithms, and safety alerts.
- The FDA is actively seeking feedback from stakeholders, including pharmacists.
Red Dye No. 3 Ban
After decades of debate, the FDA policy is revoking the use of Red Dye No. 3 in all orally ingested drugs and foods, with a compliance deadline of Jan. 18, 2028.
Why it matters:
- Expect reformulations of syrups, chewables, and coated tablets.
- Patients may notice changes in product appearance.
- Pharmacists should be ready to answer questions and monitor for updated labeling.
New FDA Policy Safety Warnings
Cetirizine and levocetirizine now carry a warning about severe pruritus when discontinued abruptly after long-term use.
What to do:
- Counsel patients on gradual tapering when appropriate.
- Be prepared to manage persistent itching symptoms.
- Recognize this as a non-traditional withdrawal reaction that could be easily overlooked.
LISTEN NOW: All of this, and more, is covered in the newest GameChangers episode – What’s New from the FDA and Why It Matters. In just a few minutes, you’ll be fully briefed on the FDA policy updates that matter most to your practice.
Host: Josh Kinsey, PharmD
Guest: Mary Ross Southworth, PharmD, Principal @ S&S Consulting Partners
