FarmaKeio

FarmaKeio spans two entities: a 503B outsourcing facility (Farmakeio Outsourcing LLC, Southlake, TX) that publicly focuses on bioidentical hormone pellets, and a larger 503A custom-compounding network that carries the broader consumer menu.

Facility & accreditation

The 503B (Farmakeio Outsourcing LLC) is on the FDA Registered Outsourcing Facilities list ^[1], and its own page advertises patented bioidentical hormone pellets delivered to medical practices ^[2]. The 503A arm — “North American Custom Laboratories, LLC, dba FarmaKeio Superior Custom Compounding” — runs retail/compounding sites (Richardson, TX; Conway, AR; Albuquerque, NM) and says it is licensed in 49 states plus PR and USVI ^[2]. We independently confirmed PCAB accreditation for the 503A arm in ACHC’s own directory (listed as “North American Custom Labs / FarmaKeio,” Richardson, TX; PCAB Compounding Pharmacy) ^[3]. Additional badges on the site (IPS, A4PC) are memberships, not independently verified here. FarmaKeio’s 503A entity is also a named plaintiff in the outsourcing-industry (OFA) litigation over the GLP-1 shortage delistings.

What they compound

The 503B publicly advertises bioidentical hormone pellets ^[2]. The broader FarmaKeio network markets weight loss, hormone therapy, thyroid/adrenal, and sexual health to providers and patients ^[2]. Compounded GLP-1 (semaglutide/tirzepatide) is attributed to FarmaKeio by a third-party directory but is not stated on the company’s own 503B page, so we flag GLP-1 as unverified from a primary source.

Regulatory record

The FDA has issued FarmaKeio two warning letters. On July 29, 2021 it wrote to FarmaKeio Outsourcing, the Southlake 503B, after an October 2019 inspection, citing inadequate adverse-event reporting procedures and testosterone pellets compounded as copies of an approved drug ^[4]. On November 18, 2022 it wrote to the Richardson 503A (North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding) after a March 2022 inspection, citing sterile products prepared under insanitary conditions; the firm had recalled its sterile products in April 2022, and the FDA posted a close-out letter for that warning letter dated January 27, 2026 ^[5]. Both are in our register of warning letters to compounding pharmacies. The FDA 503B list shows the Southlake facility with an “Open” action status ^[1]. (A third-party directory reports a Form 483 around September 2025; we could not locate the FDA primary document, so we don’t assert it.) Dated to our review; status can change.

The read

One of the better-credentialed consumer-facing options here: the 503A arm is PCAB-accredited (independently confirmed via ACHC), the menu covers HRT and weight loss, and the 2022 warning letter to the 503A has been closed out; the 2021 letter to the 503B has not. The main nuance is entity structure — the 503B publicly commits only to hormone pellets, so verify exactly which entity fills a given order.

References

1. FDA — Registered Outsourcing Facilities (503B) list. (accessed 2026-07-01)
2. FarmaKeio — official site (503B outsourcing + custom compounding). (accessed 2026-07-01)
3. ACHC / PCAB accredited-organization directory (listed as “North American Custom Labs / FarmaKeio,” Richardson, TX). (accessed 2026-07-01)
4. FDA — Warning letter, FarmaKeio Outsourcing LLC, case 608257, July 29, 2021. (accessed 2026-10-21)
5. FDA — Warning letter, North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, case 642792, November 18, 2022. (accessed 2026-10-21)