Compounded medications
Compounded medications are drugs prepared by a pharmacy for an individual patient — combining, altering, or formulating ingredients outside FDA-approved manufacturing — under Section 503A or 503B of federal law.
- Prepared per patient under Section 503A, or in bulk under 503B
- Not FDA-approved — oversight is state boards plus federal tier rules
- Legitimate for allergies, dose forms, shortages, and combinations
- Copying commercially available drugs is generally prohibited
When compounding is appropriate
The legitimate cases: a patient allergic to an inactive ingredient in the commercial product, a dosage form that does not exist commercially (a liquid for someone who cannot swallow tablets, a specific titration strength), drugs in shortage, and clinically valid combinations without a manufactured equivalent. Compounded drugs are not FDA-approved — quality rests on the pharmacy’s practices and the regulatory tier it operates under.
The compounding moment in telehealth
Compounded GLP-1s during the shortage years brought medical weight care to a much larger population, and as shortages resolved the category moved to the patient-specific pathway — individualized preparations supported by documented clinical need. Peptides, hormones, and personalized dosing keep compounding central to DTC pharmacy, which is why the 503A bulks list and PCAC votes are watched like earnings reports. Programs built on compounded products are strongest with rigorous documentation, sourcing diversity, and catalog flexibility as standing policy.
The three legal bases for a 503A compound
Every lawful 503A compound rests on one of three foundations:
| Basis | What it means | Example |
|---|---|---|
| 503A bulks list (incl. Category 1) | Substances the FDA has cleared — or nominated substances under active evaluation with interim enforcement discretion | NAD+, sermorelin |
| USP–NF monograph | The substance has an official quality standard in the US Pharmacopeia | progesterone |
| Component of an FDA-approved drug | The active ingredient already exists in an approved product | oxytocin |
Quality control, practically
The certificate of analysis is the load-bearing document: it states what a specific lot of API contains, at what purity, tested how. A pharmacy worth partnering with sources from FDA-registered suppliers, verifies CoAs per lot, and runs its own potency and sterility testing on finished preparations. Beyond-use dates are the other tell — honest BUDs reflect USP defaults and real stability data; suspiciously long ones reflect optimism.
Who actually does the compounding
Compounding happens in two kinds of facility, and knowing which is which shapes every program decision. 503A compounding pharmacies are state-licensed pharmacies preparing patient-specific prescriptions — the fulfillment engine behind ship-to-patient telehealth, including hormone, peptide, and GLP-1 programs. 503B outsourcing facilities are FDA-registered manufacturers compounding in bulk under cGMP — the source for clinic and med-spa office stock. A national program typically works with multiple 503A partners (for licensure coverage and redundancy) and adds a 503B relationship when an in-person channel appears.
Compliance handled, so you can build
Lithos runs the clinicians, pharmacies, and 50-state rules behind your care program — one API.
Frequently asked questions
Are compounded medications safe?
From licensed, well-run pharmacies operating within the rules, compounding is a longstanding part of practice — but products lack FDA premarket review, so pharmacy quality is the variable that matters.
Why were compounded GLP-1s everywhere?
Shortage-era rules permitted broad compounding of drugs in shortage; as shortages ended, the category moved to the standing patient-specific pathway.
Can any pharmacy compound?
Only pharmacies equipped and licensed for it — and what they may compound is bounded by the bulks lists and copy restrictions.