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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 5

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 5 of 20
DoseLogDan
Member
201
567
Feb 2025
Montana
Mar 2, 2024 at 8:54 AM#21
hyun_seoul said:
Compounding pharmacy customer here with experience relevant to compounded supply.

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.

35 10newstart_MO, mia_MS2, LeilaHI and 32 others
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nick_newbie
New Member
18
56
Jun 2026
Virginia
Online
Mar 2, 2024 at 5:56 PM#22

Following on from hyun_seoul — and this may be the naive question:

What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?

34 9dan_philly, MeganSA_TX, LarryQC_SD and 31 others
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JakeSmashed95
Member
412
1,890
Aug 2024
Arkansas
Online
Mar 3, 2024 at 2:58 AM#23
DoseLogDan said:
Compounded has been just as effective for me.

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: Mar 3, 2024 at 7:58 AM
33 8alex_tucson, kevin_tulsa, Dr.PainCLE and 30 others
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rick_sfbay
Member
289
1,234
Jan 2025
San Francisco, CA
Mar 3, 2024 at 12:01 PM#24
DoseLogDan said:
Compounded has been just as effective for me.

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

Last edited: Mar 3, 2024 at 6:01 PM
32 7FranDenver, Dr.BariatricHTX, LindaRN_retired and 29 others
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Dr.NephBHM_UK
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456
2,123
Jun 2024
Birmingham, UK
Mar 3, 2024 at 9:04 PM#25
DoseLogDan said:
Compounded has been just as effective for me.

This answered a question I did not know how to ask. Taking it to my next appointment.

Last edited: Mar 4, 2024 at 3:04 AM
31 6PeptideChemSF, A1cHero_PHX, Dr.RenalNash and 28 others
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