GLP-1 and metabolic

GLP-1 APIs: read the status before you order.

We list semaglutide, tirzepatide and liraglutide with their current FDA status, and name the manufacturer for each lot on the quote.

Price-check one item Request the supplier file

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Current FDA status

A 503B currently has no bulk pathway for these three. Both shortages are resolved (tirzepatide Dec 19, 2024; semaglutide Feb 21, 2025). FDA proposed on May 1, 2026 not to add them to the 503B bulks list.
We supply semaglutide as the base form only. FDA says the salt forms can't lawfully be used in compounding.
GLP-1 APIs must come from a manufacturer on FDA's Import Alert 66-80 Green List.
We don't source substances FDA has said can't lawfully be compounded.

What we list (14)

503B Category 1 FDA interim policy, conditions applyCategory 2 FDA safety risk, outside the interim policyBiologic not eligible for 503A/503B compoundingWithdrawn list not for human compoundingNo 503B pathway not on the bulks list, the shortage list or in Category 1503A HHS draft policy formVeterinary animal compounding

Status as of Nov 14, 2026. Sources: FDA 503B categories list (updated Mar 21, 2025), FDA Category 2 page (current Apr 22, 2026), 21 CFR 216.24, 21 CFR 530.41, 21 CFR 600.3(h)(6), HHS FR 2026-22192. No item we list is on the 503B bulks list today. Shortage status is checked when we price your request. Labels are a starting point, not a determination for your facility.

5-Amino-1-Methylquinolinium Iodide (NNMTi) No 503B pathwayPrice this item
FDA named 5-amino-1MQ as ineligible under 503B in a Jan 2026 warning letter.
Acarbose No 503B pathwayPrice this item
Amlexanox No 503B pathwayPrice this item
AOD-9604 Acetate No 503B pathwayPrice this item
FDA previously listed safety concerns (nomination withdrawn from Category 2).
CB4211 Acetate No 503B pathwayPrice this item
Not found in FDA’s 503B category list; status to be verified.
Liraglutide No 503B pathwayPrice this item
No current 503B bulk pathway. Off the shortage list (tirzepatide Dec 19, 2024; semaglutide Feb 21, 2025). FDA proposed May 1, 2026 not to add it to the 503B bulks list. Manufacturer must be on FDA Import Alert 66-80 Green List.
MOTs-C Acetate No 503B pathway 503A: HHS draft policyPrice this item
503A: covered by the HHS draft six-peptide policy (Oct 30, 2026) in the acetate form, by the listed routes, if all 10 conditions are met. Draft, nonbinding.
Orlistat No 503B pathwayPrice this item
Salcaprozate Sodium (SNAC) No 503B pathwayPrice this item
Semaglutide No 503B pathwayPrice this item
No current 503B bulk pathway. Off the shortage list (tirzepatide Dec 19, 2024; semaglutide Feb 21, 2025). FDA proposed May 1, 2026 not to add it to the 503B bulks list. Manufacturer must be on FDA Import Alert 66-80 Green List. Base form only. FDA says the salt forms have no lawful basis for compounding.
Setmelanotide Acetate No 503B pathwayPrice this item
SLU-PP-332 No 503B pathwayPrice this item
Not found in FDA’s 503B category list; status to be verified.
Tesamorelin Acetate No 503B pathwayPrice this item
44 amino acids; biologic status unverified.
Tirzepatide No 503B pathwayPrice this item
No current 503B bulk pathway. Off the shortage list (tirzepatide Dec 19, 2024; semaglutide Feb 21, 2025). FDA proposed May 1, 2026 not to add it to the 503B bulks list. Manufacturer must be on FDA Import Alert 66-80 Green List.

Questions

Can a 503B compound semaglutide or tirzepatide from bulk?

Not under a current bulk pathway. Both are off the shortage list and are not on the 503B bulks list.

Which semaglutide form do you supply?

The base form only.

Is the manufacturer on the Green List?

GLP-1 APIs must come from a manufacturer on FDA's Import Alert 66-80 Green List. Ask us to confirm for the lot you're quoted.

Every quote includes

A written price and pack size per item, the lot COA, and each item's FDA status as of the date we price it. Nothing ships until you approve the price sheet.

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