Bulk APIs for 503A pharmacies, with the paperwork up front.
The same documents we give 503B outsourcing facilities: lot COA, traceability and a dated status per item. No membership.
Manufacturer documentation
Provided directly by the manufacturer under NDA. The HHS draft peptide policy expects a 510-registered original manufacturer, its plant location on the COA, and validation of the manufacturer by any reseller.
Derm, hormone and ophthalmic staples
Tretinoin, tacrolimus, estriol, progesterone, bimatoprost, moxifloxacin and more. Browse the catalog.
Status on every line
Each quote line shows its dated status, so your PIC can check it against the 503A rules.
The 503A bulk rules, briefly
A 503A pharmacy may compound from a bulk drug substance that complies with a USP or NF monograph, is a component of a drug FDA has approved, or is on the 503A bulks list (21 CFR 216.23). The bulk must come from an FDA-registered establishment with a valid COA. 503A compounding is prescription-based and limited on "essentially copies" and anticipatory compounding.
The HHS six-peptide draft policy (Oct 30, 2026)
HHS published a draft enforcement policy for six peptides in specific forms and routes: BPC-157 acetate, TB-500 acetate, Epitalon acetate, MOTS-c acetate, KPV acetate and Semax free base. It applies to 503A pharmacies, not to 503B outsourcing facilities. It is a draft and nonbinding, it can change, and it applies only if all 10 of its conditions are met, including an FDA-registered original manufacturer that follows current good manufacturing practice, the manufacturer's physical location on the COA, and reseller validation of the manufacturer.
We list Semax as the acetate. The HHS draft lists Semax free base (intranasal).
Sources: 21 USC 353a; FR 2026-22192 (Oct 30, 2026). Checked Nov 14, 2026.
Send your list. Get a written price per item.
Every line comes back with a price, the lot COA and a dated status.