Where our medicines come from

Two FDA-registered distributors. A certificate of analysis on every batch.

A lot of telehealth brands won't tell you where their compounded medicines come from. We will. Here's the supply chain in plain English — and what we verify before anything ships to you.

FDA-registered, FDA-regulated wholesale distributors

Every active ingredient in your prescription comes from one of two wholesale distributors that are registered with the FDA, operate under federal oversight, and are subject to inspection. We don't buy from gray-market suppliers, overseas resellers, or research-chemical sources — and we won't.

A certificate of analysis on every medication

Each batch arrives with a third-party Certificate of Analysis (COA) confirming identity, purity, and potency against the labeled spec. We retain those COAs and make them available on request. If a batch's COA falls outside spec, that batch doesn't ship.

Sterility verification before anything is dispensed

Every batch of injectable medication is tested for sterility before it reaches a patient. We won't dispense an injectable from an unverified batch. This isn't optional and it isn't a marketing line — it's a release criterion.

Why this matters

Compounded medicines are legal — but the supply chain is where the integrity is.

Compounded peptides, hormones, and weight-loss medications are legitimate prescription medicines made by state-licensed compounding pharmacies under federal regulation (503A and 503B of the FD&C Act). When the supply chain is clean, they're a vital part of personalized care — especially in cases where an FDA-approved version doesn't exist or isn't the right fit for a specific patient.

The variability that gets compounders in trouble isn't the compounding rules — it's where the active ingredients come from. Some operators source from research-chemical sites, foreign resellers, or unverified bulk suppliers. We won't. We sourced from FDA-registered wholesale distributors precisely because we wanted the same quality assurance you'd expect for any other prescription medicine.

Every medication ships with documentation showing what it is, that it's sterile, and where it came from. If you ever want to see your prescription's COA, ask us. That's the promise.

What we will always do

Source actives from FDA-registered wholesale distributors only
Confirm identity, purity, and potency via third-party COA on every batch
Verify sterility on every injectable batch before it’s released to a patient
Dispense only through state-licensed compounding pharmacies
Share the documentation with you when you ask

What we will never do

Source from research-chemical sites or overseas resellers
Ship a batch that didn’t pass identity or sterility testing
Refuse to tell you where your medication came from
Market substances we can’t verify under federal regulation

Common questions

What patients ask us most.

What is a Certificate of Analysis?

A COA is a third-party lab report showing that a specific batch of a medication contains exactly what it’s labeled to contain — at the right purity, potency, and identity. It’s standard practice for pharmaceutical-grade actives and we require one for every batch.

Why two distributors instead of one?

Redundancy. If one distributor has a stock-out, a recall, or a documentation gap on a specific batch, we can source the same medication from the second without compromising the COA + sterility requirements.

What does “FDA-registered wholesale distributor” actually mean?

Wholesale drug distributors that operate across state lines register with the FDA and report annually under section 503(e) of the FD&C Act. They’re subject to FDA inspection and have to demonstrate Good Distribution Practice (GDP). It’s the same regulatory framework large hospital systems and retail pharmacies rely on.

Can I see the COA for my prescription?

Yes. Message your care team after your medication ships and we’ll send you the batch-specific COA. We don’t publish them publicly because they’re tied to specific lot numbers, but they’re available to every patient on request.

Are compounded medicines FDA-approved?

Compounded medications themselves aren’t individually FDA-approved — they’re prepared per patient by state-licensed compounding pharmacies under the 503A framework. What is regulated: the active ingredients (sourced from FDA-registered distributors), the pharmacies (state licensed and FDA-inspected), and the rules around what may be compounded. That’s where our quality assurance lives.

Compounding & the law

How compounding works — and why it's legal.

Many medications available through New Tides are compounded — prepared for an individual patient by a licensed compounding pharmacy rather than mass-manufactured.

Compounding is a long-established, legal part of pharmacy practice. Compounding pharmacies operate under Section 503A of the federal Food, Drug, and Cosmetic Act and are licensed and regulated by their state board of pharmacy. Under that framework, a pharmacy may compound a medication — including from bulk substances — for a patient who has a valid prescription.

Compounded medications are not FDA-approved. The FDA approves finished, mass-manufactured drug products; it does not review or approve individual compounded preparations for safety, effectiveness, or quality. That does not make them unlawful — it means they're overseen through the pharmacy-compounding and state-licensing system rather than the new-drug approval system.

Which medications a pharmacy can compound, and how it sources and tests its ingredients, is determined by the pharmacy under its federal and state obligations — not by New Tides. Our role is the clinical evaluation and, where appropriate, the prescription.

FDA status

We tell you the FDA status of every medication.

Here's what the labels on our site mean:

FDA-approved: An FDA-approved finished medication.
Compounded · not FDA-approved: The active ingredient is FDA-approved as a brand for a specific use; our compounded version is not.
No approved product · compounded medication: There is no FDA-approved finished product today; it is available as a compounded medication.
Not FDA-approved · compounded: No FDA-approved product in any form.