Category Boundaries
A physician sets which peptides your clinic offers and on what basis, in writing.
Peptide Therapy
Find a Medical Director for Peptide Therapy
Peptides move faster than the guidance around them. A director who is comfortable with the category, protocols written to your state, and vendors that clear diligence are what keep a peptide program defensible.
Medical Director Oversight
What a Director Actually Signs Off for Peptide Therapy
Each of these is a decision your director owns, in writing, before it happens in your clinic.
Protocol Sign-Off
Dosing, cycling and stacking rules approved before they reach a patient.
Sourcing Discipline
Research-use presentations kept out of patient care, with the rule written down rather than assumed.
Adverse-Event Route
A documented escalation path your injectors know without asking.
What We Set Up
Everything Behind a Compliant Peptides Program
Peptide programs live or die on sourcing and documentation. We set both, then keep them current as categories shift.
Standing orders per peptide and route of administration
Sourcing rules: 503A, PUO and RUO boundaries made explicit
Screening, dosing and cycle protocols
Consent and patient-education documents
Lot documentation and storage requirements
Category gating tied to your credentials and state
Supply
Where the Product Comes From
FAQ
Questions About Peptide Therapy
Still not sure? Twenty minutes on the phone answers what a page can't.
Are Peptides Legal to Offer?
It depends on the specific peptide, its compounding status and your state. We tell you which of the ones you want are workable and which are not before you stock anything.
Who Can Administer Them?
That follows your state’s delegation and supervision rules, which your standing orders will set out per provider type.
What Is the Difference Between a Category 1 and a Category 2 Peptide?
Category 1 substances may be used in 503A compounding while FDA finishes reviewing them — a licensed compounding pharmacy will make them for a named patient. Category 2 substances were flagged for significant safety risk and are not appropriate for compounding at all. A peptide on neither list has simply not been reviewed, which is not the same as being cleared.
What About Research-Use Products?
They stay out of patient care. Your protocols say so explicitly, which is what a board looks for.
Category 1 vs. Category 2
Not Every Peptide Is Allowed to Be Compounded
When FDA reviewed bulk peptide substances for use in 503A compounding, it sorted them into lists. Category 1 substances may be compounded while review continues. Category 2 substances were flagged for significant safety risks and are not appropriate for compounding. That single distinction decides whether a peptide belongs on your menu, and it is the first thing we check before a clinic stocks anything.
Category 1Compoundable
Reviewed and Permitted While Review Continues
Bulk substances placed in Category 1 may be used in 503A compounding while FDA completes its evaluation. These are the peptides a properly licensed compounding pharmacy will make for a named patient on a valid prescription.
What It Means for YouA 503A pharmacy will compound them patient-specifically
They can sit in a protocol with dosing, screening and consent attached
Sourcing still matters — the pharmacy and its documentation get diligenced
Status is provisional: a substance can move as review completes
Category 2Not for Compounding
Flagged for Significant Safety Risk
Category 2 substances were identified as raising significant safety concerns for use in compounding. They are not appropriate for 503A compounding, and a clinic offering them is operating outside what the pharmacy framework supports.
What It Means for YouA legitimate 503A pharmacy will decline to compound them
They do not belong in a protocol, a consent or a treatment menu
Sourcing them anyway usually means an unlicensed or research supplier
The clinic and the prescriber carry that exposure, not the seller
A third bucket catches people out: plenty of peptides sit on neither list. They are not cleared for compounding by being absent — they simply have not been reviewed, and a compounder working properly will not make them for patient use. Anything sold as research-use-only belongs in that bucket too, and it stays out of patient care entirely.
Category lists change as FDA completes review. Membership keeps your protocol and your catalog in step with the current lists rather than the ones in circulation when you opened — and your director confirms what your clinic offers.
Who Is Allowed to Own a Peptides Business?
Can a non-physician own a peptide clinic? Not the prescribing entity. Peptide therapy is medical treatment, and in most states the professional entity behind it must be physician-owned even when the business around it is not.
That is what the corporate practice of medicine doctrine decides — and it is the single rule that shapes how your business is built. Most states hold that medical judgment belongs to licensed clinicians, so a non-physician or a general corporation may not own or control an entity that practices medicine. The MSO model is the answer the industry settled on.
The Rule
CPOM — Corporate Practice of Medicine
A doctrine in state law, not a company or a service. The professional entity — the PC — must be owned by a licensed physician, and control counts as much as ownership: who hires the clinicians, who sets the fees, who decides what gets treated.
Only a licensed physician may own the professional entity in most states
Control counts too — hiring clinicians, setting fees, directing treatment
Fee-splitting rules limit how the MSO can be paid
Enforcement is by medical boards, attorneys general, insurers and acquirers
The Structure
MSO — Management Services Organization
The company that provides everything a Peptides clinic needs that is not the practice of medicine, under a written management services agreement with the PC. You can own the MSO outright, whatever your license.
Owned by you, whatever your license — no physician equity required
Holds the brand, lease, staff, systems, supply and marketing
Paid a fair-market management fee, never a cut of clinical revenue
Takes no part in diagnosis, treatment or any clinical decision
How the two meet: a physician-owned PC employs the clinical team and holds the medical decisions; your MSO holds the brand, the lease, the staff, the systems and the supply; a fair-market management fee moves between them; and the line is drawn in writing where your state says it must be. 503A sourcing and vendor accounts sit with the MSO; what gets prescribed, to whom, stays with the physician.
Watch
Where the Money Actually Goes
What This Covers
How money actually moves through a PC/MSO structure — patient revenue landing in the PC, the fixed management transfer to the MSO, MedGrid's retainer, and physician compensation — the same CPOM flow of funds covered on this page, walked through step by step.
This isn't just how we recommend running the accounts. In a state that enforces corporate practice of medicine, this exact flow is required to keep a PC structure compliant: revenue lands in the PC first, the MSO is paid a fixed, fair-market amount rather than a share of medical revenue, MedGrid is paid a fixed retainer by the MSO, and the accounts stay separate.
It's also why MedGrid only builds on a PC — never a PLLC — in every state we work in. A PLLC lets revenue flow straight into a member's account with no equivalent separation, which is exactly the structure this flow of funds is built to avoid. Why that distinction matters.
Getting It WrongMistake 01 Mistake 02 Mistake 03 Mistake 04
Four Ways Peptides Clinics Get Structured Badly
These are the arrangements we most often find in place when a clinic comes to us, usually built in good faith, on advice from someone who had not read the state's rules.
An LLC That Should Be a PC
The clinical entity was formed as a plain LLC owned by a non-physician. In a strict state that is the whole problem, and it usually surfaces at diligence or renewal.
A Director on a Handshake
A physician agreed to "be the medical director" with no management agreement, no delegation document and no standing orders. There is nothing to show a board.
A Fee That Looks Like a Split
The MSO takes a percentage of clinical revenue. Many states read that as fee-splitting regardless of what the contract calls it.
Protocols From a Course
Treatment protocols copied from a training weekend, never adapted to this state or signed by the director who is supposed to own them.
General information about how these structures work, not legal advice for your clinic. Your director and your counsel confirm the specifics before you treat.
Other Modalities We Cover
GLP-1 Weight LossHRT / TRTIV Drips & HydrationInjectables & NeurotoxinsTelehealth PrescribingSkin & ResurfacingHair RestorationOzone TherapyLongevity DiagnosticsLasers & Energy DevicesExosomes & RegenerativeVitamin InjectionsSexual Wellness
Adding Peptides to Your Menu?
Twenty minutes tells you what direction costs in your state, what has to be on file before the first patient, and how fast you can start.