Medication Safety Policy

Last Updated: March 24, 2026

When you start a weight loss program at StackMD, you deserve to know exactly where your medication comes from, how it’s made, and what we require before it ever reaches you. This page explains our compounding standards, current FDA regulations, and what to watch out for in a market that has unfortunately attracted some bad actors.

What “Compounded” Means

A compounded medication is custom-prepared by a licensed pharmacist for a specific patient based on a provider’s prescription. It is not mass-produced and has not gone through FDA premarket review for safety, effectiveness, or manufacturing quality.

Compounding has a legitimate place in medicine — but it requires careful oversight, especially for injectable medications like GLP-1 receptor agonists.

The Current Regulatory Landscape (2026 Update)

This is the part most clinics aren’t being upfront about — so we will be.

The FDA resolved the national shortages of both major GLP-1 medications:

  • Tirzepatide (Mounjaro® / Zepbound®) — shortage resolved October 2024
  • Semaglutide (Ozempic® / Wegovy®) — shortage resolved February 2025

With those shortages resolved, compounding pharmacies are no longer permitted to produce essentially identical copies of these medications simply because patients want them. The broad shortage exception that allowed widespread GLP-1 compounding has ended.

Compounding is still legally permitted under Section 503A when:

  • A patient has a documented, individualized clinical need that cannot be met by an FDA-approved product — for example, a verified allergy to an inactive ingredient
  • A clinically indicated formulation, concentration, or delivery method is not commercially available, and the prescribing provider documents this on the prescription

Compounding is no longer a valid option for:

  • Drug shortage (both resolved)
  • Cost or insurance preference
  • Convenience or general preference
  • Weight loss without a documented patient-specific clinical need that distinguishes it from the approved product

At StackMD, every compounded GLP-1 prescription includes documented clinical rationale in accordance with current FDA guidance and New York state law. If a compounded option isn’t appropriate for your situation, we’ll tell you that directly.

Our Pharmacy Standards

When a compounded medication is clinically appropriate and legally permitted, we only work with pharmacies that meet every one of the following requirements. No exceptions.

Licensing and Registration

  • State-licensed 503A compounding pharmacies only
  • PCAB (Pharmacy Compounding Accreditation Board) accredited
  • cGMP (current Good Manufacturing Practice) compliant

Ingredient Integrity

We do not accept:

  • Semaglutide sodium or semaglutide acetate — these are salt forms not considered lawful for human compounding and are not equivalent to the FDA-approved active ingredient
  • Research peptides or chemicals labeled “for research use only”
  • Investigational analogues (e.g., retatrutide) not approved for patient use

Only the correct active pharmaceutical ingredient (API), sourced from an FDA-inspected manufacturer, is acceptable.

Testing and Documentation

Every medication lot must include:

  • Certificate of Analysis (CoA) from an independent third-party lab
  • Potency testing
  • Sterility verification
  • Endotoxin screening
  • Stability data supporting the beyond-use date (BUD)

Labeling Requirements

Every label must clearly show:

  • Drug name and exact formulation
  • Concentration in mg/mL (not units)
  • Lot number
  • Beyond-use date
  • Storage conditions
  • Clear dosing instructions with a dose-by-volume chart

Cold-Chain Integrity

  • Refrigerated shipping with tamper-evident packaging
  • Documented replacement protocol for any temperature exposure during transit

Safety Information

Who Should Not Use Compounded GLP-1 Medications

Do not use if you have:

  • Personal or family history of medullary thyroid cancer or MEN2 syndrome
  • History of severe allergic reaction to the medication or its components
  • Pregnancy or plans to conceive (semaglutide should be stopped at least 2 months before attempting pregnancy)
  • Severe gastroparesis or serious gastrointestinal disorders

Use with caution if you have kidney disease, diabetic eye disease, or a history of pancreatitis. Always disclose your full medical history to your provider.

Common Side Effects

Most patients experience some GI adjustment, especially early on:

  • Nausea, vomiting, diarrhea, constipation, abdominal discomfort

These typically improve with proper titration. Your provider will work with you on dosing to minimize discomfort.

Serious Risks

Contact us promptly or seek emergency care for:

  • Severe or persistent vomiting or abdominal pain
  • Signs of dehydration (dizziness, dark urine, decreased urination)
  • Vision changes
  • Chest pain
  • Suspected allergic reaction

Less common but serious risks include gallbladder disease, pancreatitis, kidney injury from dehydration, and low blood sugar when combined with insulin or sulfonylureas.

Drug Interactions to Know

  • Tirzepatide and oral contraceptives — Use backup contraception for 4 weeks after starting and after each dose increase
  • Oral semaglutide and levothyroxine — Thyroid monitoring may be needed
  • Any GLP-1 before surgery or procedures — Always notify your anesthesia team; GLP-1s slow gastric emptying and affect anesthesia protocols

Dosing and Administration

Because compounded products use vials rather than pre-filled pens:

  • Your label must list concentration in mg/mL
  • You must receive a dose-by-volume chart — never dose by “units” without a conversion chart
  • Never mix medications unless specifically directed by your provider
  • Do not reconstitute powder unless trained to do so by the pharmacy

Storage and Disposal

  • Refrigerate as instructed; do not freeze
  • Protect from light
  • Never use beyond your beyond-use date
  • Dispose of needles in an FDA-approved sharps container

Red Flags to Avoid

The GLP-1 market has real bad actors. Avoid any source that:

  • Sells via social media or direct message
  • Is labeled “research chemical” or “for research use only”
  • Cannot be verified through the FDA outsourcing facility registry or NABP pharmacy listings
  • Has labels missing mg/mL concentration, lot number, or beyond-use date
  • Uses the terms “semaglutide sodium” or “semaglutide acetate”
  • Offers pricing that seems too good to be true — it usually means lower-grade ingredients

You can verify pharmacies at:

If Something Doesn’t Seem Right

Contact StackMD right away for:

  • Ongoing vomiting or abdominal pain
  • Signs of dehydration
  • Confusion about your dose
  • Any concern about your medication’s appearance, packaging, or labeling

Seek emergency care immediately for chest pain, severe abdominal pain, allergic reactions, or sudden vision changes.

You may also report concerns directly to the FDA MedWatch program at fda.gov/safety/medwatch.

Questions?

We’re straightforward about what we prescribe, why we prescribe it, and what the rules are. If you have questions about your medication or whether a compounded option is appropriate for you, reach out.

care@stackmdwellness.com | 516-324-2974

Medical 360 HC PLLC DBA StackMD | Albertson, NY

The FDA has not evaluated statements on this page. Compounded medications are not FDA-approved. This page is for informational purposes only and does not replace individualized medical advice from your provider.