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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 7

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 7 of 20
mark_tokyo
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Tokyo, JP
Jun 6, 2024 at 9:31 PM#31
RegAffairsDC said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

Last edited: Jun 7, 2024 at 12:31 AM
34 9pete_manc_UK, anna.melb_AU, mark_tokyo and 31 others
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pete_RVA
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Dec 2024
Richmond, VA
Jun 14, 2024 at 8:37 PM#32
RegAffairsDC said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 4 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

33 8Dr.Martinez, mike_mod, SarahChen_PharmD and 30 others
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EndoResFellow
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Sep 2024
Baltimore, MD
Jun 22, 2024 at 7:38 PM#33
RegAffairsDC said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

That reframing is the part I needed. Taking it to my next appointment.

Last edited: Jun 22, 2024 at 9:38 PM
32 7paul_denver, TinaHashiRN, robert_kc and 29 others
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lisa_labSD
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Oct 2024
San Diego, CA
Jun 30, 2024 at 6:34 PM#34

Clinical perspective, offered as context rather than as advice.

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

Feature503A503B
RegulationState Board of PharmacyFDA-registered
PrescriptionRequired (patient-specific)Can compound without patient Rx
TestingVaries by statecGMP required
ScaleSmall batchesLarger production
Quality consistencyVariableGenerally higher

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

Last edited: Jun 30, 2024 at 9:34 PM
31 6lori_vegas, Dr.PulmRoch, maya_sedona and 28 others
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Dr.PeteFamMed
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Minneapolis, MN
Jul 8, 2024 at 5:26 PM#35
lisa_labSD said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

Adding a me-too, because a thread of one person's experience is not much use. Posting only so the count is not one.

30 5FranDenver, Dr.BariatricHTX, LindaRN_retired and 27 others
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