Absolute Pharmacy: what the records show

Why does the FDA list Absolute as a former outsourcing facility?

After the Drug Quality and Security Act of 2013 created the 503B category, Absolute Pharmacy registered with the FDA as an outsourcing facility. Outsourcing facilities must follow federal current good manufacturing practice (CGMP) rules, the standard drug manufacturers follow. Outsourcing-Pharma reported in May 2015 that the FDA sent Absolute a warning letter dated April 27, 2015. The letter said drugs meant to be sterile were "prepared, packed, or held under insanitary conditions." It also cited the lack of an adequate system for monitoring conditions in aseptic processing areas, containers that were not cleaned and sterilized to remove pyrogens, and an inadequate HEPA-filtered air supply.

Absolute later left the 503B program. The FDA's compounding actions page (current as of October 22, 2026) now lists it as a 503A facility. It does not appear among the 100 facilities on the FDA's registered outsourcing facility list updated October 29, 2026.

What the 2021 close-out and FMD-145 letters mean

A close-out letter means the FDA reviewed a firm's corrective actions and found that the violations in that warning letter appear to have been addressed. FDA close-out letters also state that they do not prevent future regulatory action if new violations are found. A close-out is not an approval or a quality certificate.

An FMD-145 letter is the cover letter the FDA sends with a copy of the Establishment Inspection Report (EIR). The FDA releases the EIR to the inspected firm once it considers the inspection "closed." Both of Absolute's letters are dated the same day, July 14, 2021, which suggests the FDA finished its review of the earlier record at that point. We found nothing newer from 2023 through October 2026.

As a 503A pharmacy, Absolute is overseen mainly by the Florida Board of Pharmacy and by the boards of the states it ships to. The FDA can still inspect a 503A pharmacy. It does not hold 503A pharmacies to the CGMP rules it applies to outsourcing facilities.

Absolute, tirzepatide and the FDA's 2026 rules

The FDA declared the tirzepatide shortage resolved on December 19, 2024. Its policy page, updated April 1, 2026, sets out the conditions every 503A pharmacy must meet, including Absolute:

• Each compounded drug must be made for an individual patient on a prescription.
• A pharmacy may not compound drugs that are "essentially copies" of an approved drug such as Zepbound regularly or in inordinate amounts.
• The FDA says it does not intend to act when a pharmacy fills four or fewer prescriptions of an essentially-copy product in a calendar month.
• Enforcement discretion for 503A tirzepatide compounding ended after a federal court denied a preliminary injunction on March 5, 2025.

In practice, compounded tirzepatide from a 503A pharmacy needs a prescriber's documented clinical reason that sets it apart from the approved product. In its September 18, 2026 warning letter to a different pharmacy, Empower, the FDA questioned prescriber notes that looked "pre-generated for selection." Compounded tirzepatide from any pharmacy is not FDA-approved.

One NexLife detail to check: as of November 4, 2026, NexLife's tirzepatide plan page names three pharmacies, but its pricing page (dated November 1, 2026) names only Absolute and Boudreaux's New Drug Store. The pharmacy printed on your vial label shows which one filled your order. See NexLife's prices and our Empower warning letter explainer.