How to Prescribe Peptides
A clinical prescribing guide for candidate selection, the approved-versus-compounded decision, informed consent, monitoring, and documentation. Written for licensed prescribers, not patients.
The stance
Peptide therapy is a legitimate therapeutic category. What separates strong practices from weak ones is discipline at a few specific decision points — not expertise in any one molecule.
Most avoidable problems in peptide prescribing do not come from the pharmacology. They come from skipping candidate selection, mis-classifying product status, shipping a generic consent waiver, and letting the follow-up plan become a rolling refill.
This guide is the prescribing workflow those problems live inside. It is written for licensed US prescribers, assumes basic familiarity with pharmacology, and is intentionally opinionated.
01 — Candidate selection
Who is a candidate?
Candidate selection is the part of the workflow most commonly collapsed. The question is not “does this patient want a peptide?” It is “does this patient have an indication a peptide plausibly addresses, with realistic expectations and the ability to complete monitoring?”
Appropriate candidates
- Clinical indication with a measurable endpoint you can track
- Evidence base exists — even if preclinical, it is coherent with the mechanism
- Prior therapies have been tried, declined with a clear reason, or are explicitly inappropriate
- Patient engages with informed consent rather than pre-selecting a peptide
- Willing and able to return for scheduled monitoring
Marginal candidates
- Indication is soft (e.g., vague fatigue, generalized "recovery," anti-aging)
- Expectations exceed what the evidence supports
- Patient is asking for a specific peptide by name before the indication is clear
- Geographic or schedule barriers to follow-up
- Complex polypharmacy without a clear peptide rationale
Do not prescribe
- Active malignancy or recent treatment, when considering growth-promoting peptides
- Pregnancy or breastfeeding, outside a narrow set of approved indications
- Patient declines informed consent or the compounded-medication disclosure
- Substance is on an active FDA removal notice or has an unresolved regulatory status
- No realistic follow-up plan for monitoring or discontinuation
02 — The regulatory decision
Classify the product before you classify the patient
The word “peptide” flattens four categories with completely different consent, sourcing, and documentation requirements. Run this decision first. Everything downstream depends on it.
Approved, on-label
Examples
- Tesamorelin for HIV-associated lipodystrophy
- Semaglutide (Ozempic / Wegovy) for type 2 diabetes or obesity at labeled BMI
- Tirzepatide (Mounjaro / Zepbound) for type 2 diabetes or obesity at labeled BMI
Consent requirements
Base consent is sufficient. No off-label or compounded-medication addendum required.
Sourcing posture
Dispense the FDA-approved manufacturer product per label.
Approved, off-label
Examples
- Semaglutide for PCOS or metabolic syndrome without T2DM
- Tesamorelin for visceral-adipose reduction outside the HIV-LD indication
- Tirzepatide for weight management below the labeled BMI threshold
Consent requirements
Base consent plus an off-label addendum. Document evidence basis, alternatives considered, and explicit patient acknowledgment of off-label use.
Sourcing posture
FDA-approved manufacturer product. Expect insurance denials; the patient should know upfront whether cash-pay is the realistic path.
Compounded (503A or 503B)
Examples
- Semaglutide or tirzepatide during a documented FDA shortage
- BPC-157 or TB-500 for soft-tissue or GI indications (currently investigational)
- CJC-1295 / ipamorelin combinations for GH-axis applications
Consent requirements
Base consent plus compounded-medication addendum. Add off-label addendum if the indication is also off-label. Explain 503A (patient-specific) versus 503B (registered outsourcing facility, eligible for office use).
Sourcing posture
Verify pharmacy licensing in the dispensing state, Category 2 compliance, and release-testing documentation. For 503B, verify current FDA registration.
Investigational / high-scrutiny
Examples
- Substances on the April 2026 FDA removal notice list (BPC-157, Semax, Epitalon, Dihexa, Cathelicidin LL-37, GHK-Cu injectable, KPV)
- Substances with pending PCAC consultations and no clear 503A bulks-list posture
- Unlabeled research-chemical-grade products regardless of source
Consent requirements
Not appropriate for routine clinical prescribing while posture is unresolved. If considered on a named-patient basis, draft a tight risk-benefit rationale, cite the specific regulatory document, and obtain explicit regulatory-status acknowledgment.
Sourcing posture
Generally decline. Verify the exact current FDA posture through the Federal Register and the pharmacy's own compliance statements before any further discussion.
03 — Informed consent
What the consent packet must cover
A generic waiver is not informed consent. The packet should cover seven domains. Missing any one of them is the most common audit finding against peptide-prescribing practices.
Clinical rationale
- Specific indication, not a category (e.g., "Achilles tendinopathy" not "injury")
- Measurable therapeutic endpoint
- Expected timeframe to response and to reassessment
Evidence basis
- Summary of the evidence for this specific indication
- Explicit distinction between preclinical and human data
- Citations patients can look up independently
Risks
- Material adverse effects specific to the peptide class
- Injection-related risks if parenteral
- Drug interactions with current medications
Alternatives
- Other pharmacologic options considered and why rejected
- Non-pharmacologic options considered
- Risks and expected trajectory of no treatment
Product status
- FDA-approval status of the product
- Off-label use disclosure, if applicable
- Compounded-medication disclosure, if applicable, including 503A vs 503B
Business interests
- Any financial relationship between the prescriber and the dispensing pharmacy
- Any revenue the practice earns from peptide prescribing
- Confirmation the patient is not required to source through any specific pharmacy
Follow-up
- Scheduled re-evaluation intervals
- How to report adverse events between visits
- Criteria for discontinuation
04 — Monitoring
The monitoring cadence
Set the follow-up plan at initiation. “Return as needed” is not a follow-up plan — it is how chronic refills happen without decisions. Use fixed intervals tied to the peptide class and the indication.
Before initiation
- Baseline labs appropriate to the peptide class (e.g., IGF-1 for GH-axis peptides, A1c and lipid panel for GLP-1 agents, CBC and CMP broadly)
- Photography or measurement for body-composition indications
- Documented therapeutic endpoint and reassessment date
- Signed consent packet filed in the chart
Loading phase, weeks 1–4
- Portal or phone check-in at week 1 for tolerability
- Injection-site assessment at week 2 where relevant
- Adverse event documentation with action taken
Effect evaluation, week 8–12
- Re-measure the therapeutic endpoint against the baseline
- Repeat safety labs where the peptide class indicates (e.g., IGF-1, thyroid, lipids)
- Documented decision: continue, adjust, or discontinue
Maintenance or discontinuation
- Reassess every 3 months if therapy continues
- Discontinuation criteria documented at initiation so the decision is not ad hoc
- Rationale at each interval — not a rolling refill
05 — Documentation
Chart-note elements that survive an audit
Write the note in the same language as the consent packet. If the packet and the note describe the product differently, reviewers will notice. These are the elements the note should contain for every peptide prescription.
- 01HPI framed by the therapeutic rationale — not the patient's peptide request
- 02Evidence summary you discussed, with brief source attribution
- 03Alternatives considered and why they were rejected
- 04Explicit product-status classification (approved on-label, approved off-label, compounded, investigational)
- 05Material risks disclosed, in the same language as the consent packet
- 06Patient questions and your responses
- 07Prescriber financial-interest disclosure where applicable
- 08Consent packet version and date filed
- 09Follow-up plan with specific intervals
Starter Pack
Get the packet your staff can actually use
The starter pack turns this workflow into files: bundled consent packet, editable templates for each addendum, one-page routing checklist, and a chart-note skeleton that matches the consent language. Free for licensed prescribers.
06 — When to decline
Criteria for declining the prescription
Declining is part of the workflow. A practice that never declines is not practicing candidate selection. Use these criteria as automatic decision points, not judgment calls you revisit under patient pressure.
Decline or refer out
- The patient is requesting a specific peptide before a clinical indication has been established. Return to indication first.
- The indication is primarily cosmetic or “anti-aging” without a measurable clinical endpoint.
- The patient cannot or will not engage with the informed-consent process, or refuses the compounded- medication disclosure.
- The regulatory status is actively unclear — active removal notice, pending PCAC consultation without defined posture, category-2 entries without a clear exception path.
- You cannot verify the pharmacy’s licensing, Category 2 compliance, or release-testing documentation.
- The patient has an active contraindication — malignancy for growth-promoting peptides, pregnancy for most peptides outside narrow approved indications.
- You do not have a realistic monitoring plan, or the patient cannot complete it.
Guide Review
Reviewed by PeptidePrescriber Editorial Team, Clinical content review.
What to open next
Turn the guide into a working kit
The most useful next step is to open the consent templates and the regulatory reference in the order a real patient encounter will need them.
Base consent, off-label, compounded-medication, and GLP-1 addenda.
503A, 503B, April 2026 removal notices, and shortage status.
Evidence-graded references with dose, half-life, sequence, and mechanism.
The complete packet with editable files and a staff implementation checklist.