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ForumsCompounding & FormulationState-by-state compounding pharmacy regulations — what worked for you?

State-by-state compounding pharmacy regulations — what worked for you?

alex_tucson Mon, Sep 9, 2024 at 6:46 PM 9 replies 1,701 viewsPage 1 of 2
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alex_tucson
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May 2024
Tucson, AZ
Sep 9, 2024 at 8:11 PM#1

I'm trying to compile information on how different states regulate compounding pharmacies, especially for GLP-1 peptides. I've discovered that what's allowed in Texas might be completely different from what's allowed in New York, and it's incredibly confusing.

Anyone have experience navigating this patchwork? Specifically:

  • Which states have the strictest regulations?
  • Which states allow out-of-state compounding pharmacies to ship in?
  • Are there states where compounded semaglutide is effectively banned?
48 22emily_PDX, Dr.SleepRoch, laura_annarbor and 45 others
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bri_stats
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May 2024
Seattle, WA
Sep 9, 2024 at 8:28 PM#2

This is a massive topic but I'll give you the highlights from my research:

STRICTEST STATES:

  • California: Requires resident pharmacist for compounding, strict Board of Pharmacy oversight, recent crackdown on telehealth-prescribed compounded medications
  • New York: Historically strict on out-of-state shipments, requires pharmacy to be licensed in NY
  • Massachusetts: Post-NECC, arguably the tightest compounding regs in the country

MORE PERMISSIVE STATES:

  • Texas: Large compounding pharmacy industry, generally business-friendly regulatory environment
  • Florida: Home to many 503B outsourcing facilities, relatively permissive
  • Utah: Has carved out specific provisions for compounding

CROSS-STATE SHIPPING:

503B outsourcing facilities (federally registered) can generally ship across state lines. 503A pharmacies typically need to be licensed in the receiving state, though enforcement varies.

7 12mike.trainer_LA, sarah_nash92, FitDadDave and 4 others
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marco_milano
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Jul 2024
Milan, IT
Sep 9, 2024 at 8:45 PM#3

Adding to what was shared above's excellent summary — the key legal concept is that 503A pharmacies are regulated by STATE boards, while 503B facilities are regulated by FDA at the federal level. This creates a two-tier system where a 503A in Florida might be able to do things a 503A in California can't.

For consumers, the practical question is usually: "Can Pharmacy X in State Y ship to me in State Z?" The answer depends on whether the pharmacy is licensed in your state. Most of the big compounding pharmacies hold licenses in multiple states for this reason.

Last edited: Sep 10, 2024 at 12:45 AM
49 24Dr.LipidDallas, alex_tucson, kevin_tulsa and 46 others
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jim_asheville
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Asheville, NC
Sep 9, 2024 at 9:02 PM#4

As someone in Texas, I can tell you the compounding pharmacy scene here is huge. Empower Pharmacy, one of the largest 503B facilities in the country, is based in Houston. Many telehealth companies source from TX-based compounders.

That said, Texas isn't the Wild West — the Texas State Board of Pharmacy does conduct inspections and has taken enforcement action. They shut down two compounders last year for violations.

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TirzTom
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Florida
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Sep 9, 2024 at 9:19 PM#5

California checking in. It's definitely harder here. My doctor prescribed compounded sema and my local pharmacy couldn't fill it — they said their license doesn't allow them to compound this particular formulation. I ended up getting it from a 503B facility in another state that's licensed in CA.

The extra hoops are annoying but I also appreciate that CA is trying to protect patients. It's a balancing act. 🤷‍♀️

38 10DeniseRN_TPA, SandraNC_45, Dr.EndoIndy and 35 others
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