Safety Information

Fifty 410 Safety Information

Compounded GLP‑1 and dual GIP/GLP‑1 receptor agonist medicines
Last updated: October 2, 2025

This page covers safety, quality, and responsible use when a GLP‑1 or dual GIP/GLP‑1 medicine is prepared by a licensed compounding pharmacy instead of the original manufacturer. Compounded products are not FDA‑approved and do not undergo FDA premarket review for safety, effectiveness, or manufacturing quality. They should only be used when legal and clinically appropriate as determined by your prescriber. (U.S. Food and Drug Administration)

1) What “compounded” means, and why that matters

• Compounded means a pharmacist prepares a medication for an individual patient based on a clinician’s prescription. These products can be made at a state‑licensed 503A pharmacy for patient‑specific prescriptions or at a 503B outsourcing facility that follows federal current good manufacturing practice and is listed with the FDA. Compounded drugs are exempt from FDA approval, which is why they carry additional risk and require stronger safeguards. (U.S. Food and Drug Administration)
  
• The FDA has issued repeated alerts about unapproved and fraudulent GLP‑1 compounds, including products with fake labels, products sold online as “research only,” and salt forms of semaglutide such as semaglutide sodium or semaglutide acetate that are a different active ingredient than the approved drug. These salts are not the same as semaglutide base used in Ozempic and Wegovy and FDA is not aware of any lawful basis for using them in human compounding. (U.S. Food and Drug Administration)
  

Shortage status matters. The FDA resolved the national shortages of tirzepatide in December 2024 and semaglutide injection in February 2025, then phased out the temporary enforcement discretion that had allowed many compounders to make “essentially a copy” of the approved products. After those dates, compounding that copies an approved product is generally not permitted unless specific legal conditions are met, such as a documented clinical difference. (U.S. Food and Drug Administration)

2) The benefits you might expect are class‑based, but the risks with compounded versions are different

GLP‑1 and dual GIP/GLP‑1 medicines can reduce A1C, support meaningful weight loss, and in some indications reduce cardiovascular events. Those are benefits demonstrated with FDA‑approved products. A compounded version is not automatically equivalent in potency, purity, or delivery. That difference is the core safety issue and the reason for the extra guardrails on this page. (U.S. Food and Drug Administration)

3) Key safety risks unique to compounded GLP‑1 products

Quality and potency variability. Compounded products do not undergo FDA review. FDA and independent drug‑information groups have warned about variable concentrations, inconsistent instructions, and product quality problems with compounded semaglutide and tirzepatide. Some adverse events requiring hospitalization have been linked to dosing mistakes with multi‑dose vials and prefilled syringes. (U.S. Food and Drug Administration)

Wrong ingredient or wrong form. FDA has found compounded products labeled as semaglutide that actually contained salt forms or other substances. Use only semaglutide base and avoid any vial labeled “semaglutide sodium” or “semaglutide acetate.” (U.S. Food and Drug Administration)

Counterfeits and knockoffs. FDA has seized counterfeit Ozempic in the legitimate supply chain and has warned about fraudulent compounded products with phony pharmacy names. Eli Lilly has reported finding bacteria and impurities in products sold as tirzepatide. Buy only from licensed pharmacies that you and your clinician know and trust. (U.S. Food and Drug Administration)

Label and measuring errors. Insulin syringes are marked in “units” of volume, not milligrams. When a compounded vial is labeled in mg per mL, even small math mistakes can cause a large overdose. FDA has published warnings after receiving reports of overdoses and hospitalizations from patients and clinicians miscalculating the dose. Your pharmacy must provide a dose‑by‑volume chart, the correct syringe, and hands‑on training. (U.S. Food and Drug Administration)

Unknown additives or combinations. Some compounders add vitamins or other agents. These mixtures have not been evaluated by FDA for safety or effectiveness. Avoid add‑ins unless there is a clear clinical rationale from your prescriber. (U.S. Food and Drug Administration)

4) Fifty 410 sourcing and quality standards

Our practice will only dispense compounded GLP‑1 products that meet all of the following:

1. Legitimate source.
   
   • Patient‑specific prescriptions are fulfilled only by state‑licensed 503A pharmacies in good standing, or by 503B outsourcing facilities that appear on FDA’s Registered Outsourcing Facilities list. If a 503B product carries an NDC, we verify that listing, understanding that NDC listing does not mean FDA approval. (U.S. Food and Drug Administration)
     
2. Correct active ingredient.
   
   • Semaglutide base only. We do not accept semaglutide salts.
     
   • Tirzepatide must be the correct, approved active ingredient when compounded lawfully and not an investigational analogue. Retatrutide and similar research peptides are not eligible for human compounding under 503A or 503B. (U.S. Food and Drug Administration)
     
3. Testing and documentation.
   
   • Certificate of Analysis for each lot that includes potency, sterility testing per USP standards, and bacterial endotoxins testing, plus validated stability data that supports the beyond‑use date printed on your label. (USP)
     
4. Labeling clarity.
   
   • Labels must display drug name, exact concentration in mg/mL, total volume, lot number, beyond‑use date (BUD), storage conditions, and clear dose‑by‑volume instructions. No ambiguous “units.” (U.S. Food and Drug Administration)
     
5. Cold‑chain and tamper security.
   
   • Refrigerated shipping when required, tamper‑evident packaging, and prompt replacement if temperature excursions or seal breaks are documented. (USP)
     

5) Who should not use these medicines, whether compounded or branded

• Personal or family history of medullary thyroid carcinoma or diagnosis of MEN2.
  
• Prior serious hypersensitivity to the same drug or its excipients.
  
• Pregnancy or plans to become pregnant. For semaglutide, stop at least two months before a planned pregnancy due to its long half‑life. Discuss breastfeeding with your clinician.
  
• Severe gastroparesis or significant gastrointestinal disease.
  
• Extra caution if you have chronic kidney disease, diabetic retinopathy, or a history of pancreatitis. These are class considerations that apply to compounded products as well. (FDA Access Data)
  

6) Common and serious side effects to watch

These effects are class‑related and can occur with compounded or branded versions.

• Gastrointestinal symptoms such as nausea, vomiting, diarrhea, constipation, and abdominal pain, most common during dose escalation. Hydration and smaller, lower‑fat meals help. (FDA Access Data)
  
• Hypoglycemia is uncommon by itself but can occur with insulin or a sulfonylurea. Your clinician may adjust those doses at initiation and during titration. (FDA Access Data)
  
• Gallbladder disease including cholelithiasis and cholecystitis. Report right upper abdominal pain, fever, or jaundice. (FDA Access Data)
  
• Acute kidney injury, often in the setting of dehydration from severe vomiting or diarrhea. Call early if you cannot keep fluids down. (FDA Access Data)
  
• Diabetic retinopathy complications have been observed with injectable semaglutide, particularly with rapid A1C improvement in those with pre‑existing retinopathy. Arrange baseline and periodic eye exams. (FDA Access Data)
  
• Pancreatitis warning. Stop the drug and seek urgent care for severe, persistent abdominal pain with or without vomiting. Do not restart if pancreatitis is confirmed. (FDA Access Data)
  

7) Dosing and administration with compounded formats

Because compounded GLP‑1s often come as multi‑dose vials or prefilled syringes rather than auto‑injector pens, training matters.

• Your label must state mg per mL. The volume to inject is calculated from that concentration. Your pharmacy must provide a printed dose‑to‑mL chart and the appropriate syringe.
  
• Never inject based on “units” unless the instructions explicitly tie units to mL for the syringe you were given. Insulin syringe markings are not milligrams. This is a common cause of overdose. (U.S. Food and Drug Administration)
  
• Do not reconstitute a powder vial at home unless your pharmacist has trained you and supplied the exact diluent and steps. Incorrect reconstitution changes concentration and can lead to severe dosing errors. (U.S. Food and Drug Administration)
  
• Do not mix your compounded GLP‑1 with any other drug in the same syringe unless your prescriber and pharmacist have specifically instructed you to do so. Safety and compatibility are not established for most combinations. (U.S. Food and Drug Administration)
  

8) Storage, handling, and beyond‑use date

• Follow the temperature on your label. Most compounded GLP‑1 injections are refrigerated. Do not freeze. Keep vials upright and protected from light.
  
• Beyond‑use date (BUD) is the date after which the compounded preparation should not be used. It reflects sterility, stability, and packaging per USP standards, not simply an arbitrary “expiration.” Do not use the product after the BUD or after a temperature excursion. (Wolters Kluwer)
  
• Sharps safety. Use only new needles, never share supplies, and place used needles in an FDA‑cleared sharps container for disposal according to local rules. (USP)
  

9) Drug interactions and special situations

• Tirzepatide and oral contraceptives. Exposure to oral contraceptives can be reduced during tirzepatide initiation and at each dose increase. Use a non‑oral or barrier method for four weeks after starting and for four weeks after each increase. (American Society of Anesthesiologists)
  
• Oral semaglutide and levothyroxine. Co‑administration increases T4 exposure. Your clinician may adjust monitoring and timing. (American Society of Anesthesiologists)
  
• Procedures and anesthesia. GLP‑1 agents slow gastric emptying. Multi‑society guidance indicates most patients can continue therapy before procedures after individualized risk assessment; your procedural team may change fasting instructions or request a temporary hold if you have active GI symptoms or are early in titration. Tell your team you use a GLP‑1 medicine. The Wegovy label includes a precaution about pulmonary aspiration during anesthesia. (American Society of Anesthesiologists)
  
  

10) Red flags and how to verify a safe source

Do not buy from social media, med‑spas, or websites selling “research chemicals.” The FDA has sent warning letters and documented fake or misbranded products. (U.S. Food and Drug Administration)

Check the source.

• If your medication is shipped from a 503B outsourcing facility, confirm the facility appears on FDA’s Registered Outsourcing Facilities list. (U.S. Food and Drug Administration)
  
• For online pharmacies, look for NABP Digital Pharmacy Accreditation and verify the business name and state license numbers. (NABP)
  
• Watch for counterfeit alerts. FDA has identified counterfeit Ozempic in U.S. distribution. If something looks off, stop and contact us. (U.S. Food and Drug Administration)
  

Check the label.

• The drug name should read semaglutide or tirzepatide, not semaglutide sodium or acetate.
  
• The label must show mg/mL, lot, BUD, and storage. If any of these are missing, do not use it. (U.S. Food and Drug Administration)
  
  

11) When Fifty 410 will consider compounded GLP‑1s

• When the prescriber determines there is a documented clinical difference that the approved product cannot meet, or during a constrained supply situation where compounding is lawful and clinically necessary. As of today, FDA considers semaglutide and tirzepatide injection shortages resolved, and the temporary enforcement discretion has ended. We comply with these federal timelines. (U.S. Food and Drug Administration)
  

12) What to do if problems arise

• Call your Fifty 410 care team for persistent nausea, repeated vomiting, inability to keep fluids down, severe constipation, new abdominal pain, symptoms of low blood sugar, or any confusion about dosing or syringes. (FDA Access Data)
  
• Seek urgent care for severe, unrelenting abdominal pain, signs of gallbladder infection, symptoms of an allergic reaction such as swelling or trouble breathing, or sudden vision changes. (FDA Access Data)
  
• Report to FDA MedWatch. Adverse events, product quality problems, and suspected counterfeit or fraudulent products can be reported directly to the FDA online. This feedback helps protect patients nationally. (U.S. Food and Drug Administration)
  

13) Quick reference table

14) For clinicians and detail‑minded readers

• Legal framework. Sections 503A and 503B govern compounding. FDA’s 2024 to 2025 updates ended enforcement discretion after GLP‑1 shortages resolved and remind compounders about restrictions on making products “essentially a copy” of approved drugs. (U.S. Food and Drug Administration)
  
• Quality standards. USP <797> sets expectations for sterile compounding environments, operator qualifications, and the scientific basis for beyond‑use dates. Your supplier should provide lot‑specific sterility and endotoxin results and stability data aligned with USP. (USP)
  
• Anesthesia and procedures. Multi‑society guidance suggests most patients can continue GLP‑1 therapy with individualized planning to minimize aspiration risk; Wegovy’s label now includes a related precaution. (American Society of Anesthesiologists)
  

15) One‑page patient checklist you can print

Before you inject the first dose

• Confirm the pharmacy is known to Fifty 410 and properly licensed or listed as a 503B outsourcing facility. (U.S. Food and Drug Administration)
  
• Read the label: look for semaglutide or tirzepatide, mg/mL, lot, BUD, storage. No salts. (U.S. Food and Drug Administration)
  
• Review the dose‑to‑mL chart and use only the syringe you received. (U.S. Food and Drug Administration)
  
• Store as directed and keep cold if required. Do not use if warm to the touch or if seals are broken. (USP)
  

Each time you dose

• Double‑check the mg ordered and the mL to inject.
  
• Rotate injection sites and log your dose and lot number.
  
• Call us if nausea, vomiting, or abdominal pain are severe or persistent. (FDA Access Data)
  

Never

• Buy from social media or “research chemical” sites.
  
• Use products labeled semaglutide sodium or acetate.
  
• Share vials or re‑use needles. Report problems to FDA MedWatch. (U.S. Food and Drug Administration)
  

Questions or symptoms right now?

Contact your Fifty 410 care team. For severe or alarming symptoms, use local emergency services.

Selected sources

• FDA: Concerns with unapproved GLP‑1 drugs, counterfeit warnings, dosing error alerts, and shortage‑resolution timeline for tirzepatide and semaglutide. (U.S. Food and Drug Administration)
  
• USP: Sterile compounding standards and BUD concepts. (USP)
  
• ASA and multisociety guidance on GLP‑1 use around anesthesia and procedures. (American Society of Anesthesiologists)
  

Reuters: Lilly findings of bacteria and impurities in counterfeit or illegal tirzepatide products. (Reuters)