Received and checked
Each bulk ingredient is held in quarantine until its label and certificate of analysis are checked.
Compounding you can see.
Lake Hills Pharmacy prepares compounded medications by hand, to USP standards, and a licensed pharmacist reviews every prescription.
The pharmacy
Meet Lake Hills Pharmacy.
Lake Hills Pharmacy is a Texas-licensed compounding pharmacy in Austin, owned by an affiliate of Nimbus Healthcare Corporation, and licensed in 37 states and DC.
It holds NABP Compounding Pharmacy Accreditation.
- 37 states and DCLicensed, and shipping to 37 states and DC, and growing.
- Section 503AA traditional compounding pharmacy that prepares patient-specific prescriptions.
- USP 795, 797, 800Non-sterile, sterile and hazardous-drug standards.
- NABP-accreditedCompounding Pharmacy Accreditation.
The process
From ingredient to delivery.
Compounded by hand
Preparations are made by hand in controlled rooms, sterile work under USP 797.
Tested and reviewed
Applicable batches go to an outside lab for sterility and endotoxin testing before release, and a licensed pharmacist reviews the prescription.
Packed and shipped
Packed at the pharmacy and shipped to patients in 37 states and DC.
Standards
The standards we work to.
Three USP chapters set how compounding is done. Lake Hills Pharmacy works to all three.
USP 795
Non-sterile compounding
Creams, capsules and other preparations made outside the clean room, with documented steps and beyond-use dates.
USP 797
Sterile compounding
The chapter for injectable preparations: clean rooms, gowning and aseptic technique.
USP 800
Hazardous drugs
Handling and containment rules for hazardous drugs, where they apply.
What we test
Lake Hills Pharmacy tests its preparations for potency and purity, and its sterile preparations for endotoxins, so what is in the vial matches the label.
- Potency testing
- Sterility testing at an outside lab, where it applies
- Endotoxin testing at an outside lab, where it applies
- Identity and purity on every ingredient's certificate of analysis
Sourcing
Ingredients from registered makers.
Suppliers are qualified before Lake Hills Pharmacy buys from them, including a check of FDA registration and the original manufacturer's CGMP information. Where an ingredient is made says little on its own. Whether its maker is registered, inspected and documented says much more.
Peptides
Peptides, compounded to the federal policy's conditions.
NABP-accredited. Tested beyond what the policy asks.
In October 2026, HHS published an enforcement discretion policy for 503A compounding of certain peptides. It is not FDA approval, and it does not add any peptide to the 503A bulks list. It covers state-licensed pharmacies, not 503B outsourcing facilities. Lake Hills Pharmacy, a 503A pharmacy, is the only pharmacy that prepares our peptides. The policy is open for public comment through November 13, 2026, and HHS may revisit it in whole or in part; if it does, we change what we prepare to match. Here is each of its ten conditions, and how Lake Hills Pharmacy meets it.
Policy conditions
The peptide appears on the policy's interim access list (Appendix A)
We compound only peptides on that list.
The peptide has the identity and route of administration the policy describes (Appendix B)
Each preparation's master formulation record names the listed peptide, its form and its route.
Bulk ingredient from an FDA-registered facility, with a valid certificate of analysis showing identity, purity, potency and the absence of harmful contaminants
Every lot is held in quarantine until its certificate of analysis is checked.
The original manufacturer is FDA-registered, follows CGMP and is named, with its location, on the certificate of analysis
Suppliers are qualified before purchase, including the original manufacturer's registration and CGMP information.
Products compounded, serious adverse events and product quality issues are reported to FDA and to the states
A written procedure reports serious adverse events and product quality issues to FDA MedWatch and to the states where preparations are made and sent, and the patient label explains how to report a problem.
The label states: This is a compounded drug product. Not for resale.
That statement is on the label of every covered preparation.
Only one active ingredient, and it is on the policy's list
Covered peptides are made as single-ingredient preparations.
Oral forms need documented bioavailability
An oral form is prepared only with that documentation on file.
Only an FDA 510(k)-cleared syringe as a device
Any syringe packed with a preparation is 510(k)-cleared.
Every other federal requirement, including sanitary compounding and a patient-specific prescription
Every preparation starts with a patient-specific prescription from a licensed clinician, and a licensed pharmacist compounds it to USP standards in a clean, controlled space.
Beyond the policy
USP 797 sterile compounding
NABP Compounding Pharmacy Accreditation
Potency testing
Sterility testing (USP 71), where it applies
Endotoxin testing (USP 85), where it applies
Identity and purity on every certificate of analysis
An outside, independent lab
It is an enforcement discretion policy, not FDA approval. HHS said it does not intend to take enforcement action against state-licensed pharmacies that compound certain listed peptides under set conditions, while FDA decides through rulemaking whether to add them to the 503A bulks list.
Licensed clinicians make every clinical decision. Licensed pharmacies prepare and dispense. Nimbus OS® is the record they share.
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