Barriers to Access

What You Can Do

Don’t fall for fakes. Follow the facts. Before you buy, verify! Quality You Can Trust vs. Gambles You Can't! Your Health Deserves the Real Thing!
Don’t fall for fakes. Follow the facts. Before you buy, verify! Quality You Can Trust vs. Gambles You Can't! Your Health Deserves the Real Thing!

What Are the Side Effects?

Before starting:

  • Talk with a licensed clinician about your health goals, risks, and alternatives.
  • Share your health history and medications in full.
  • Ask about dosing plans, follow-up schedules, and side-effect management.

Filling & handling safely:

  • Use an in-network, licensed pharmacy—not social media or unverified sellers.
  • Always check labels: drug name, strength, lot number, expiration, and storage instructions.
  • Store the medication properly, handle carefully, and use new needles each time.

Managing access:

  • Talk to your provider about coverage, appeals, or patient assistance programs.
  • Keep visit notes, denial letters, and communications to support appeals.
  • If your pharmacy runs out, ask your clinician if a temporary alternative is safe.

Take the next step toward real, lasting health.

  • Explore patient resources, connect with support groups, and join advocacy campaigns to ensure safe, affordable access for all.
  • Advocate for expanded coverage by supporting the Treat and Reduce Obesity Act (TROA)
  • Share your story to break stigma and help others

Telehealth Providers: How to Choose and What to Expect

What quality telehealth care looks like

Legitimate platforms make it clear that a prescription is not guaranteed. You’ll complete a detailed medical intake and meet a clinician licensed in your state by video or secure messaging. They will review your conditions, medications, and contraindications; discuss risks, benefits, and alternatives; set a titration plan; and schedule follow‑up to check side effects and progress. Prescriptions are sent to a state‑licensed U.S. pharmacy with transparent dispensing information (brand, strength, pen device, storage, refills). If labs or in‑person exams are clinically appropriate, they’ll order them or coordinate with your primary care team.

How the prescription is filled

Ask which pharmacy will dispense your medication and how it ships. For GLP-1s, you should receive an FDA-approved product in its labeled dosage form, such as a pre-filled injection pen or an approved oral tablet, with standard patient labeling. Avoid services that ship unmarked vials requiring you to self‑measure doses, products referencing salt forms (e.g., “semaglutide sodium/acetate”), or items labeled “not for human use/research only.” Always verify the pharmacy’s license with your state board of pharmacy.

Common red flags

Common red flags include “instant approval,” no meaningful clinician evaluation, social-media DMs as the primary sales channel, overseas shipping, refusal to identify the dispensing pharmacy, unclear product labeling, or instructions to mix or measure doses yourself. In 2026, FDA issued warning letters to 30 telehealth companies over false or misleading marketing of compounded GLP-1 products, including claims that could confuse consumers about whether a product was FDA-approved or who actually compounded it.

Questions to ask before you pay

  • Are your clinicians licensed in my state, and will I meet one before any prescription?
  • Which FDA‑approved GLP‑1 products do you prescribe, and when (if ever) do you use compounded versions? Under what specific medical criteria?
  • Which pharmacy fills the prescription? Can you send it to a pharmacy of my choice?
  • What does follow‑up look like (timing, messaging, emergencies)? Who do I contact for severe side effects?
  • How do you handle prior authorization and appeals with my health plan?
  • What are the total costs (visit, medication, shipping, membership), and are there cancellation or auto‑renewal terms?
  • How do you protect my privacy and health data? Do you sell data to third parties?

If compounding is proposed

Compounding should be rare and tied to a documented, individualized medical need that a specific FDA‑approved product cannot meet (for example, a true excipient allergy). Confirm the clinical rationale in writing; ensure the pharmacy is state‑licensed (or a registered outsourcing facility); and confirm that the product does not use salt forms or “research‑only” materials. Request clear titration instructions, and keep all documents (labels, lot numbers, receipts) in case you need to report an adverse event.

Coordinate care

Ask the telehealth team to share your plan, dosing schedule, and any lab results with your primary care clinician or specialist. Integrated care helps catch side effects early and supports safe, sustained weight‑management.

Key Finding From Partner Research

Illicit GLP‑1 Supply Chain — What we’re seeing

Partner research traces a pattern in which active pharmaceutical ingredients (APIs) for GLP‑1s are sourced from multiple overseas manufacturers, routed through intermediaries, and sold to U.S. compounders and gray‑market vendors. Some shipments are labeled “research use only/not for human use,” yet end up in products marketed to patients. At the point of sale, these products often appear as multi‑dose vials that require self‑measured dosing, are missing standardized patient labeling, and may lack consistent identifiers (e.g., lot numbers, NDCs, or clear expiration dates). This pathway increases the risk of poor quality, contamination, and dosing errors.

Additives found in illicit APIs — why they’re dangerous

Field reviews have identified unauthorized additives in certain illicit or non‑approved GLP‑1 materials. Examples reported include additional peptides (e.g., BPC‑157) and mixtures of vitamins/amino acids. Additives like these can change how the drug behaves in the body, create stability problems, and raise the risk of immunogenicity or other unexpected side effects. Because these formulations are not FDA‑approved, there is no assurance of purity, potency, or compatibility.

 

Frequently Asked Questions

Timeline and Current Policy Compounded GLP-1s

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Dec 2024:

FDA re-evaluated its earlier decision and determined that the tirzepatide injection shortage was resolved. Temporary enforcement-discretion periods were provided for certain compounders to reduce treatment disruption.

Feb 2025:

FDA determined that the semaglutide injection shortage was resolved and provided temporary enforcement-discretion periods for certain compounders.

Feb–May 2025:

FDA’s temporary enforcement-discretion periods ended in stages. For tirzepatide, all temporary enforcement-discretion periods had ended by March 19, 2025. For semaglutide, they had ended by May 22, 2025.

Sept 2025:

FDA launched a “Green List” import alert to help prevent GLP-1 active pharmaceutical ingredients with potential quality concerns from unverified foreign sources from entering the U.S. supply chain, while allowing imports from compliant manufacturers.

March 2026:

FDA issued warning letters to 30 telehealth companies over false or misleading marketing of compounded GLP-1 products.

April 2026:

FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List after finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.

May 31, 2026:

FDA reported receiving 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.

July 2026:

CMS launched the Medicare GLP-1 Bridge, providing eligible Medicare Part D beneficiaries access to certain GLP-1 medications for weight management with a $50 monthly copay. The program runs through December 31, 2027.

July 2026:

The Senate HELP Committee advanced the bipartisan SAFE Drugs Act of 2026 (S. 3794) by a 17–5 vote. The bill would strengthen transparency and reporting requirements for compounded medications, including serious adverse-event reporting and clearer labeling. On July 27, 2026, the bill was reported to the Senate and placed on the Senate Legislative Calendar under General Orders, Calendar No. 524. It has not yet passed the full Senate.

What This Means Now

Limits on Compounded GLP-1s

Compounded GLP-1 medicines are not FDA-approved and may only be prepared under specific legal conditions. In April 2026, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List after finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.

Unverified Imports Pose Risks

Bulk API from unverified foreign suppliers can be detained at the border; products labeled “research use only/not for human use” are not appropriate for patients.

Salt Forms Not Equivalent

Salt forms such as semaglutide sodium or semaglutide acetate are different active ingredients from the semaglutide used in FDA-approved medicines. FDA has said it is not aware of a lawful basis for using these salt forms in compounded drugs and has raised concerns about their safety and effectiveness.