# FarmaKeio

> Source: https://peptidewellnessusa.com/professionals/compounding-pharmacies/farmakeio/

A Texas bioidentical-hormone 503B outsourcing facility backed by a PCAB-accredited 503A custom-compounding network spanning HRT, weight loss, and sexual health.

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](https://peptidewellnessusa.com/learn/fda-warning-letters-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.](https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities) (accessed 2026-07-01)
2. [FarmaKeio — official site (503B outsourcing + custom compounding).](https://www.farmakeio.com/) (accessed 2026-07-01)
3. [ACHC / PCAB accredited-organization directory (listed as “North American Custom Labs / FarmaKeio,” Richardson, TX).](https://organization.achc.org/) (accessed 2026-07-01)
4. [FDA — Warning letter, FarmaKeio Outsourcing LLC, case 608257, July 29, 2021.](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/farmakeio-outsourcing-llc-608257-07292021) (accessed 2026-10-21)
5. [FDA — Warning letter, North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, case 642792, November 18, 2022.](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding-642792-11182022) (accessed 2026-10-21)