Florida GLP-1 clinic compliance — what FDA, AHCA, and the Board of Pharmacy expect on file in 2026.

The 2026 GLP-1 compliance picture

Between 2022 and 2024, the FDA shortage list for semaglutide and tirzepatide created a window in which 503A and 503B compounders could lawfully produce compounded versions of these molecules at scale. That window closed in stages: semaglutide came off the FDA shortage list in October 2024 and tirzepatide in December 2024. The mass-market shortage-exception that powered the first wave of online GLP-1 clinics is no longer the legal basis for compounding either molecule.

The 2026 reality is more nuanced than the headlines made it sound. Compounded GLP-1 prescriptions have not disappeared — they have moved from a broad shortage-allowed category into a narrower patient-specific clinical-justification category. A 503A pharmacy may still produce a compounded semaglutide or tirzepatide prescription for a specific patient where there is a documented clinical reason: an allergy or sensitivity to an excipient in the FDA-approved product, a dose not commercially available, a documented intolerance, or other patient-specific clinical need. What is no longer permitted is routine, undocumented copy-cat compounding for cost or convenience.

The practical effect inside a Florida weight-loss clinic is that the per-patient documentation burden has gone up, not down. Each compounded GLP-1 dispense now needs a charted clinical justification — not a stock paragraph, but the specific reason that this specific patient cannot use the FDA-approved product. The 503A pharmacy will ask for it. The AHCA inspector will pull a sample and look for it. The malpractice carrier renewing your policy will ask the medical director to attest to the workflow.

GLP-1 prescription drugs are not on any DEA schedule (II–V). They are prescription-only legend drugs regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. DEA registration is not required to prescribe them. Controlled-substance prescriptive authority is not required for an ARNP to prescribe them. § 893 controlled-substance prescribing rules do not apply. What does apply: the entire prescription-drug, telehealth, supervisory, and standard-of-care framework, which is plenty.

The regulatory stack, with primary sources

A defensible Florida GLP-1 clinic stitches together provisions from federal FDA law, Florida statutes, Florida Administrative Code, and Board of Medicine / Board of Pharmacy guidance. The eight provisions that come up in every inspection or carrier review:

• § 458.348 — supervisory agreement and the 25-mile rule. The ARNP / PA supervisory framework. A Florida-licensed MD or DO supervises the ARNP or PA performing GLP-1 patient encounters, under a written protocol that includes GLP-1 specifically. The protocol must identify the supervising physician and describe how supervision actually occurs. See our § 458.348 explainer for the full framework.
• § 456.47 — telehealth prescribing. Replaced § 456.0625 in 2019. Defines what counts as a qualifying practitioner-patient relationship for telehealth prescribing: real-time, synchronous audio + video. Phone-only and text-only encounters do not qualify. Out-of-state telehealth providers must register under § 456.47 separately.
• § 400.9905 — AHCA Health Care Clinic licensure. Most GLP-1 weight-loss clinics that bill third-party payors must hold an AHCA HCC license (with limited exemptions). The license entails a Medical Director attestation, a designated office location, and AHCA surveys that will pull GFE charts, supervisory protocols, and standing orders. See our AHCA HCC explainer.
• 21 CFR 503A — FDA patient-specific compounding. Governs traditional state-licensed compounding pharmacies producing patient-specific compounds against a valid prescription. Most GLP-1 compounding in Florida flows through 503A pharmacies. Patient-specific clinical justification is the post-shortage requirement.
• 21 CFR 503B — FDA-registered outsourcing facilities. Larger compounders registered directly with the FDA, subject to cGMP under 21 CFR 211. May produce office-stock for non-patient-specific use. Far stricter quality oversight; more expensive product; cleaner compliance posture if you can find a 503B that produces what you need.
• Florida Administrative Code Rule 64B8-9.009 — Good Faith Exam. The Board of Medicine standard for the patient encounter that must precede any prescription medical procedure. For GLP-1, the GFE establishes the practitioner-patient relationship, documents BMI / comorbidities / medication reconciliation, and records the rationale for GLP-1 therapy. See our GFE in Florida explainer.
• § 458.331(1)(t) — standard of care. The catch-all under which Board of Medicine enforcement against MD and DO prescribers is anchored. The GFE, the supervisory protocol, and the chart-review cadence are what investigators measure against the standard of care.
• OIG / LEIE screening. If your GLP-1 clinic bills any federal payor (Medicare, Medicare Advantage, Tricare, VA), monthly OIG / LEIE checks on owners, supervising physicians, ARNPs, PAs, MAs, and the billing staff are expected. A LEIE hit on any covered person is a federal exclusion event. ProofOps runs these monthly and stamps the run date on each list pull.
• 21 CFR 211 — cGMP. Applies if you source from a 503B outsourcing facility. The clinic itself is not the manufacturer, but the BAA and supply agreement with the 503B should reference the 503B's cGMP compliance and the documentation chain from the facility through your clinic to the patient.

The telehealth GFE question for GLP-1

The combination most Florida GLP-1 clinics actually operate under is: an ARNP or PA performs a telehealth encounter under § 456.47, performs a Good Faith Exam under Rule 64B8-9.009 during that encounter, prescribes a compounded GLP-1 under § 458.348 with the supervising MD's protocol authorizing it, and ships from a 503A pharmacy with a patient-specific prescription. Each of those layers has its own documentation expectation.

A defensible telehealth GFE for a GLP-1 patient in Florida in 2026 includes:

• Real-time synchronous audio + video. Not phone. Not chat. Not asynchronous messaging followed by a prescription. § 456.47 specifically references real-time two-way audio and video. A documented video encounter of meaningful duration — long enough to actually conduct the assessment described below — is the defensible posture.
• Unambiguous patient identification in the chart. Full legal name and date of birth (or MRN). Not initials. Not first name plus last initial. AHCA and Board of Medicine reviewers cite initials-only charts routinely.
• Documented clinical assessment. BMI calculated from documented height and weight (not patient-reported alone), blood pressure if measured, relevant comorbidities (diabetes, prediabetes, hypertension, hyperlipidemia, sleep apnea, fatty liver, PCOS), and the patient's weight-history narrative.
• Medication reconciliation. Current medications and supplements, with attention to anticoagulants, insulin or sulfonylureas (hypoglycemia risk), other GLP-1 receptor agonists, pancreatitis-risk drugs, and any product with relevant interactions.
• Contraindication screening. Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, history of pancreatitis, severe gastroparesis, pregnancy or planned pregnancy, breastfeeding. Each contraindication answered explicitly, not assumed by default-No.
• Rationale for GLP-1 therapy over alternatives. Why GLP-1 is the appropriate intervention for this patient at this time, given diet / exercise history, prior weight-loss attempts, and risk profile. A template paragraph identical across 200 charts is not credible.
• Rationale for compounded versus FDA-approved product. If the patient is being prescribed a compounded GLP-1 rather than the FDA-approved equivalent, the patient-specific clinical justification belongs here in the chart — not in a separate folder, not in the pharmacy's records only.
• Supervising MD identification. Name, Florida license number, and the supervisory protocol reference. The chart entry by the ARNP or PA should make the supervising MD discoverable in seconds.
• Recurring re-exam interval. When the patient is due for the next GFE-level re-assessment. Commonly 6 to 12 months for stable GLP-1 patients, or sooner upon material change.

A 60-second template video where the practitioner reads off a script does not satisfy this standard. Neither does a chat-based "consultation" followed by a prescription. The defensible practice is a documented synchronous audio-video encounter of meaningful duration, with a chart note that reflects the actual exchange and the actual clinical decision-making.

503A versus 503B sourcing, in plain English

Where your GLP-1 vials come from materially changes your compliance posture. The two lanes:

503A patient-specific compounding pharmacies

A 503A pharmacy is a traditional state-licensed compounding pharmacy that produces a compound against a valid patient-specific prescription. Most GLP-1 compounding in the United States flows through 503A. Key characteristics:

• State board of pharmacy oversight (Florida Board of Pharmacy if the pharmacy is Florida-licensed; out-of-state pharmacies shipping into Florida must hold a Florida non-resident pharmacy permit);
• FDA oversight under Section 503A of the FFDCA, but not under cGMP 21 CFR 211;
• Production tied to a specific patient prescription — the clinic must send the prescription before the compound is produced and shipped;
• Post-shortage (2026): patient-specific clinical justification expected per dispense;
• PCAB (Pharmacy Compounding Accreditation Board) accreditation is voluntary but is the quality signal most clinics look for — verify on the PCAB website.

503B outsourcing facilities

A 503B facility is registered directly with the FDA and may produce non-patient-specific batches for office-use stock. Key characteristics:

• Direct FDA oversight, subject to cGMP requirements under 21 CFR 211 — meaningfully stricter than 503A;
• May produce office stock without a patient-specific prescription, allowing the clinic to hold inventory and dispense from it;
• FDA-registered list is publicly searchable;
• Typically higher product cost; cleaner compliance posture if a 503B produces what you need;
• Adverse event reporting and recall pathways are direct from the 503B to the FDA, which the clinic relies on but does not run.

The documentation a Florida clinic keeps on its compounding pharmacy is the same regardless of lane: the pharmacy's name, state license number, federal registration (503A or 503B), PCAB accreditation status if any, the executed BAA, the executed supply agreement, the verification that the pharmacy is in good standing with its state board, and the verification that the pharmacy's principals are not on OIG / LEIE if you bill federal payors. Re-verified annually.

What ProofOps does for your GLP-1 clinic

ProofOps Medical is a Florida-only, done-for-you compliance department — not another compliance software subscription, not a binder, not a checklist you fill in yourself. Think of us as your fractional compliance desk: technology does the heavy lifting across nine regulatory frameworks, and a real person reviews and signs off on the work before it lands in your file. The eight workflows that touch a GLP-1 clinic most directly are below. We handle them for you, on the schedule the frameworks require, and we surface the resulting artifacts in an inspection-ready binder on demand. You don't lift a finger.

• We capture every patient-qualification record and telehealth GFE in structured form. For each new GLP-1 patient we hold the full qualification protocol on file — BMI from documented height and weight, comorbidity screening, the contraindication answers, and the rationale for GLP-1 over alternatives — alongside the synchronous audio + video flag, patient identifiers (full legal name + DOB), supervising MD reference, and the rationale for compounded versus commercial product. We read it from the EMR, a real person reviews it, and gaps are surfaced before the next appointment.
• We track telehealth versus in-person on every weight-management exam. Each GFE and re-exam is tagged by encounter type, so your file shows at a glance which patients were qualified by § 456.47 synchronous video and which were seen in person — and flags any telehealth encounter logged as phone-only or chat-only before an inspector ever sees it. The audio + video requirement is where most telehealth GLP-1 charts fail; we close that gap for you.
• We lot-track every vial of compounded GLP-1 from pharmacy through patient. Each shipment from the 503A or 503B is logged with lot number, pharmacy reference, and the patients each vial is dispensed to. If the FDA or pharmacy issues a recall, you have the patient list in minutes, not weeks.
• We build bulletproof source verification for your compounding pharmacy — and re-run it annually. Your fractional compliance desk verifies and documents that every GLP-1 vial traces back to a legitimate, properly registered source: the pharmacy's state license, federal registration (503A or 503B), PCAB accreditation status if applicable, current BAA and supply agreement, and standing with the state board of pharmacy. Re-checked every year, reviewed by a real person, and stamped with the date — the documentation that shields you when the state escalates its compounding crackdown.
• We pull MD chart-review samples on Mondays. Ten percent of the prior week's GLP-1 encounters (or whatever cadence your supervisory protocol specifies), routed to the supervising MD, with the review note, date, and any clinical feedback recorded back into the EMR and the inspection-ready PDF.
• We document clinical justification for every patient-specific compound. The post-shortage requirement. Each compounded GLP-1 dispense gets a per-patient clinical justification attached to the chart — not a stock paragraph, but the specific reason that patient cannot use the FDA-approved product. The 503A pharmacy receives it; the inspector finds it.
• We build the malpractice-renewal exhibit 60 days before policy renewal. Carriers renewing GLP-1 clinic policies in 2026 ask for documented evidence of the GFE workflow, the supervisory protocol, the chart-review cadence, the OIG / LEIE screening, and the sourcing pharmacy due diligence. We assemble it before the carrier asks.
• We maintain the standing order vault with MD signature + dating. The standing order for compounded GLP-1, the supervisory protocol authorizing ARNP / PA prescribing, and any amendments are stored with signature date and the supervising MD's Florida license number. Expirations and re-signature triggers are surfaced before the document goes stale.
• We assemble the FDA / AHCA inspection PDF on demand. When an inspector arrives or a complaint investigation opens, we produce the inspection-ready PDF: GFE samples, supervisory protocol, standing orders, compounding-pharmacy due diligence, lot-tracking logs, MD chart reviews, OIG / LEIE runs, and the malpractice declarations page. Page one is the index. Page two is the summary. The inspector does not flip through binders.

Pricing — how we work with Florida GLP-1 clinics

Three tracks. All Florida-only. All include the eight workflows above and the broader nine-framework coverage. Setup is white-glove (we configure the EMR connection, the supervisory protocol vault, the pharmacy due-diligence file, and the inspection PDF template for your clinic).

• Lighthouse 5. $0 per month for the first 30 days, $1,195 one-time Historical Compliance Migration & Audit setup. Capped at 5 Florida clinics. Day 31 converts to a locked $599 per month founding rate. Designed for the first five Florida clinics we onboard at this tier — we are deliberately building the inspection track record on a small initial cohort before opening more broadly.
• Managed Evidence. $999 per month + $1,795 one-time setup. The standard track for a single-location Florida clinic.
• Multi-Location. $1,695 per month + $599 per additional location + $2,495 one-time setup. For Florida operators running multiple GLP-1 or weight-loss locations under one medical director.

What an FDA, AHCA, or Board of Pharmacy inspector actually asks for

Inspection triggers for Florida GLP-1 clinics fall into three buckets. The records each inspector pulls are different.

FDA inspection or 483 letter

Typically triggered by a complaint about the compounding-pharmacy product, an adverse event report, or a broader sweep of compounded GLP-1 sourcing. The FDA's focus is upstream — on the 503A or 503B pharmacy and on whether the clinic is sourcing properly. Records typically requested:

• The compounding pharmacy's name, state license, and FDA registration (503A or 503B);
• The executed BAA and supply agreement with that pharmacy;
• Patient-specific prescriptions on file for each compounded dispense (if 503A);
• The documented patient-specific clinical justification for each compound;
• Lot numbers tracked from pharmacy through the patient receiving the vial;
• Adverse-event records and the clinic's adverse-event reporting procedure;
• The standing order or written protocol authorizing the compounded GLP-1.

AHCA Health Care Clinic survey

Triggered on the regular AHCA survey cycle or by a complaint under § 408.812. AHCA's focus is the clinic's licensure compliance and patient-record posture. Records typically pulled:

• The HCC license, Medical Director designation, and any amendments;
• A sample of GFE charts (typically 10 to 20 charts from the prior 60 days);
• The written supervisory protocol with the supervising MD and any ARNPs / PAs;
• Standing orders for compounded and FDA-approved GLP-1;
• OIG / LEIE screening records for owners, supervising physicians, and key staff;
• Adverse-event documentation and follow-up.

Florida Board of Pharmacy or Board of Medicine complaint

Triggered by a patient or third-party complaint to either Board. Board of Medicine focuses on the MD or DO's standard of care under § 458.331(1)(t); Board of Pharmacy focuses on the pharmacy relationship and prescription validity. A § 456.073 inquiry typically opens with a 20-day response window. Records typically requested:

• The named patient's complete chart, including every GFE;
• The supervisory protocol covering the period of the complaint;
• The standing order under which the GLP-1 was prescribed and dispensed;
• The compounding pharmacy's records and dispensing log for the named patient;
• The MD chart-review record for the period.

Common gaps we see in pre-engagement audits

Across the Florida GLP-1 clinics we have audited in 2025 and 2026, the patterns repeat. Five of the most frequent gaps:

• Telehealth GFE documented only by intake form. The intake form is patient-supplied data. A defensible GFE is a practitioner-authored note. Many clinics rely on the intake plus a 30-second video and a template paragraph — that is the configuration carriers and AHCA flag.
• No documented patient-specific clinical justification for the compound. The shortage is over. "FDA-approved product is too expensive" is not a clinical justification. The chart needs the specific clinical reason, per patient, per dispense.
• BAA with the compounding pharmacy expired or never executed. The pharmacy relationship is HIPAA-covered. A current BAA is expected; many clinics signed one in 2022 and never renewed it as the pharmacy or the clinic ownership changed.
• OIG / LEIE screening run once and never repeated. Monthly screening is the expectation if you bill federal payors. A one-time screening at hire is not enough.
• Supervisory protocol that does not mention GLP-1. A generic ARNP / PA supervisory protocol drafted before the clinic added GLP-1, never amended to authorize the new prescribing. The ARNP is prescribing outside the written protocol — a recurring Board of Medicine and Board of Nursing finding.

Frequently asked questions

Can Florida medspas still compound semaglutide in 2026?

It is nuanced — neither flatly legal nor flatly illegal. The FDA removed semaglutide from its official shortage list in October 2024 and tirzepatide in December 2024, which ended the broad shortage-exception that had enabled mass-market compounding. As of 2026, a 503A pharmacy may still produce patient-specific compounded semaglutide or tirzepatide where there is documented clinical justification — for example, a documented allergy to an inactive ingredient in the FDA-approved product, a clinical sensitivity, or a dose not commercially available — but routine, undocumented copy-cat compounding is no longer permitted. The per-patient clinical justification has to be in the chart. Verify your specific protocol with your pharmacist and your Florida-licensed healthcare attorney.

Is telehealth GLP-1 prescribing legal in Florida?

Generally yes, under § 456.47 (which replaced § 456.0625 in 2019). A Florida-licensed practitioner may establish a practitioner-patient relationship and prescribe a GLP-1 by real-time synchronous audio + video telehealth. A telephone-only encounter or a text / chat-only encounter does not satisfy the standard. Each encounter still requires unambiguous patient identification (full legal name + DOB, not initials), a documented assessment including BMI and relevant comorbidities, a medication reconciliation, and a documented rationale for the GLP-1 therapy over alternatives. The supervisory protocol under § 458.348 should explicitly contemplate telehealth GLP-1 prescribing if ARNPs or PAs are doing the encounters.

What is the difference between 503A and 503B compounding pharmacies for GLP-1?

A 503A pharmacy is a traditional state-licensed compounding pharmacy that produces patient-specific compounds against a valid prescription, regulated primarily by the state board of pharmacy and Section 503A of the Federal Food, Drug, and Cosmetic Act. A 503B outsourcing facility is registered with the FDA, follows cGMP requirements under 21 CFR 211, and may produce non-patient-specific batches for office-use stock under stricter quality oversight. Clinics sourcing GLP-1 from a 503A must have a valid patient-specific prescription on file before the compound is shipped; clinics sourcing from a 503B may hold office stock but the 503B itself is subject to far more rigorous FDA oversight.

Do I need a Good Faith Exam for every GLP-1 patient in Florida?

Yes. A defensible Good Faith Exam is required before any prescription medical procedure or prescription drug administration in a Florida clinic under Board of Medicine Rule 64B8-9.009 and § 458.331(1)(t) standard of care. For GLP-1, the GFE must document patient identification (full legal name + DOB), BMI, weight, blood pressure, relevant medical and medication history, contraindications screening (personal or family history of medullary thyroid carcinoma, MEN 2, pancreatitis, severe gastroparesis, pregnancy or planned pregnancy), the rationale for GLP-1 over alternatives, and the supervising practitioner's identification. See our Good Faith Exam in Florida explainer for the full framework.

What records does an FDA inspector ask for at a GLP-1 clinic?

FDA inspections of GLP-1 clinics in Florida typically focus on the compounding-pharmacy relationship and product sourcing rather than the clinic's clinical records, which fall to AHCA and the Board of Medicine. Expect requests for: the compounding pharmacy's name, state license, and federal registration (503A or 503B); the BAA or supply agreement with the pharmacy; patient-specific prescriptions on file for each compounded GLP-1 dispense (if 503A); lot numbers tracked from pharmacy through patient; the documented clinical justification for each patient-specific compound; and any adverse-event reports. AHCA and Board of Medicine will pull GFE charts and supervisory protocols on a separate visit.

Can an ARNP prescribe compounded GLP-1 in Florida?

Yes, an ARNP licensed under Chapter 464 may prescribe GLP-1 (compounded or commercial) in Florida, provided the prescription is within the ARNP's scope, the ARNP holds the appropriate prescriptive authority, and the prescription is consistent with the written supervisory protocol or autonomous-practice registration. GLP-1 prescription drugs are not DEA-scheduled, so controlled-substance prescriptive authority is not required for them specifically — but the GFE, the supervisory protocol (if applicable), and the clinical justification for compounded versus commercial product still must be on file. Confirm scope and protocol structure with your healthcare attorney.

How often does the supervising MD need to chart-review GLP-1 patients?

Florida statutes do not set a single GLP-1-specific chart-review interval, but the standard of care framework and the supervisory protocol under § 458.348 should specify one. A common defensible practice is a documented sample chart review at least weekly — typically 10 percent of the prior week's GLP-1 encounters — by the supervising physician, with the review note, the date, and any clinical feedback recorded in the EMR. The protocol should also specify re-exam triggers (material change in medical history, adverse event, dose change, weight plateau, switch between molecules) and a periodic re-exam interval for each active patient.

What happens if the FDA shortage list status changes again?

Compounding from semaglutide and tirzepatide tracks the FDA shortage list. If a molecule returns to the shortage list in the future, the broad shortage-exception under Section 503A would re-open for the duration of the listed shortage. If a molecule is removed from the list (as both were in 2024), patient-specific compounding may still occur with documented clinical justification but routine mass-market compounding is restricted. The defensible practice is to monitor the FDA shortage list each month, document the basis for compounding each patient's product (whether shortage-allowed or clinical-justification-allowed), and update the chart language whenever the list status changes. Verify with your pharmacist and healthcare attorney.

This page is informational. It is not legal or medical advice and should not be relied upon as the basis for clinical or sourcing decisions. The FDA shortage status of semaglutide and tirzepatide, the patient-specific clinical-justification standard for 503A compounding, and the enforcement posture of the FDA, AHCA, and the Florida Board of Pharmacy each shift faster than any static page can track. For interpretation specific to your clinic, your sourcing pharmacy, and your patient population, consult your Florida-licensed healthcare attorney, your medical director, and your compounding pharmacist. Sources cited: Florida Statutes § 458.347, § 458.348, § 458.331, § 456.47, § 400.9905; Florida Administrative Code Rule 64B8-9.009; FDA guidance on compounding under Sections 503A and 503B of the FFDCA, 21 CFR 211; FDA Drug Shortages list (semaglutide removed October 2024, tirzepatide removed December 2024); and Board of Medicine and Board of Pharmacy published guidance as of May 2026.