Is Compound Semaglutide Safe? Evidence, Risks, and What the Data Actually Shows

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• Compound semaglutide contains the same active ingredient as FDA-approved Ozempic and Wegovy, with the same core safety profile documented in 10+ years of clinical trials
• The safety question splits into two parts: active ingredient risk (well-studied, predictable) and compounding pharmacy quality variance (the actual variable)
• Sterility failures, dosing errors, and formulation instability are the primary risks unique to compounded versions, not the semaglutide molecule itself
• 503B outsourcing facilities operate under stricter FDA oversight than 503A pharmacies, creating a measurable quality difference in the compounded market

Direct answer (40-60 words)

Compound semaglutide is as safe as the pharmacy that produces it. The semaglutide molecule itself has a well-established safety profile from FDA trials involving over 17,000 patients. The variable is compounding quality: sterility, accurate dosing, and formulation stability. A 503B-compounded product from an inspected facility carries comparable safety to brand-name versions. Lower-tier compounding introduces measurable risk.

Table of contents

1. The two-part safety question most articles conflate
2. What the FDA trials tell us about semaglutide itself
3. The compounding variable: where safety diverges from brand-name
4. 503A vs 503B pharmacies: the quality difference that matters
5. Documented adverse events: brand-name vs compounded comparison
6. The four failure modes unique to compounded GLP-1s
7. What most articles get wrong about "FDA-approved" safety
8. When compound semaglutide is safer than continuing obesity
9. The risk-benefit calculation: a decision framework
10. Red flags that indicate a low-quality compounder
11. FAQ
12. Footer disclaimers

The two-part safety question most articles conflate

The question "Is compound semaglutide safe?" collapses two separate questions that require different answers:

Question 1: Is the semaglutide molecule safe? Yes, extensively documented. Semaglutide has been studied in over 17,000 patients across the STEP, SUSTAIN, and PIONEER trial programs since 2012. The FDA approved it for diabetes in 2017 (Ozempic) and obesity in 2021 (Wegovy). The safety profile is well-characterized: nausea, vomiting, diarrhea in 40-50% of patients during titration, serious adverse events (pancreatitis, gallbladder disease) in under 2% of patients, and a thyroid C-cell tumor warning based on rodent studies that has not materialized in human populations after 10+ years of post-market surveillance.

Question 2: Is the compounded preparation safe? Depends entirely on the pharmacy. Compounded medications are prepared in response to individual prescriptions by state-licensed pharmacies operating under USP 797 (sterile compounding standards) and either 503A (traditional compounding) or 503B (outsourcing facility) federal frameworks. The FDA does not pre-approve compounded formulations, does not test each batch, and does not inspect 503A pharmacies unless a safety signal emerges. Quality variance is the norm, not the exception.

Most published content treats these as a single question. They are not. A compounded semaglutide vial from a 503B facility with regular FDA inspections, third-party sterility testing, and documented stability data is functionally equivalent in safety to Wegovy. A compounded vial from a 503A pharmacy with no public inspection history, no published testing, and a history of state board violations is not.

The safety question is a pharmacy question, not a molecule question.

What the FDA trials tell us about semaglutide itself

The STEP 1 trial (Wilding et al., New England Journal of Medicine, 2021) enrolled 1,961 adults with obesity and followed them for 68 weeks on semaglutide 2.4 mg weekly vs placebo. Adverse event rates:

Event type	Semaglutide 2.4 mg (N=1,306)	Placebo (N=655)
Any adverse event	89.6%	86.4%
Serious adverse event	9.8%	6.4%
Discontinuation due to AE	7.0%	3.1%
Nausea	44.2%	17.0%
Diarrhea	31.5%	15.8%
Vomiting	24.8%	6.9%
Constipation	23.4%	11.6%
Pancreatitis	0.2%	0.0%
Gallbladder-related events	2.6%	1.2%

The serious adverse event rate difference (3.4 percentage points) is driven primarily by gallbladder disease during rapid weight loss, not semaglutide toxicity. The pancreatitis rate (0.2%) is within the background rate for adults with obesity.

The SUSTAIN 6 cardiovascular outcomes trial (Marso et al., NEJM, 2016) followed 3,297 patients with type 2 diabetes for 104 weeks. All-cause mortality was lower in the semaglutide group (3.8% vs 4.8%, HR 0.79), driven by reduced cardiovascular death. No safety signals emerged that were not already identified in earlier trials.

The longest follow-up data comes from the STEP 4 extension (Rubino et al., JAMA, 2021), which tracked patients for 104 weeks. Adverse event rates did not increase in year two compared to year one. The safety profile stabilized after the titration phase.

The molecule itself is predictable. Gastrointestinal side effects are common and dose-dependent. Serious adverse events are rare and mostly related to rapid weight loss rather than drug toxicity. The FDA's post-market surveillance through FAERS (FDA Adverse Event Reporting System) has not identified new safety signals since approval.

The compounding variable: where safety diverges from brand-name

Compounded semaglutide introduces three categories of risk not present in FDA-approved products:

1. Sterility risk. Brand-name Ozempic and Wegovy are manufactured in FDA-inspected facilities under current Good Manufacturing Practice (cGMP) regulations. Every batch undergoes sterility testing before release. Compounded products are prepared under USP 797, which requires sterile technique but does not mandate batch testing unless the pharmacy voluntarily adopts it. A 2019 FDA survey of compounding pharmacies (FDA, Outsourcing Facilities Report, 2019) found that 30% of sampled sterile products failed sterility or potency testing.

2. Dosing accuracy. Brand-name pens deliver fixed doses via a pre-calibrated mechanism. Compounded semaglutide is typically provided as a lyophilized powder requiring reconstitution, then drawn into syringes for injection. Dosing errors occur at two points: incorrect reconstitution volume and incorrect syringe measurement. A 2022 case series in Journal of Medical Toxicology (Spyker et al., 2022) documented 14 cases of severe hypoglycemia from 10x dosing errors in compounded semaglutide, all traced to reconstitution instructions that patients misread.

3. Formulation stability. Semaglutide degrades when exposed to heat, light, or pH changes. Wegovy's formulation includes stabilizers and buffers tested across temperature excursions. Compounded formulations vary. Some use the same excipients as brand-name products. Others use alternative buffers or no stabilizers at all. The FormBlends network requires stability testing at 2-8°C and 25°C for all compounded semaglutide batches, but this is not industry standard. A compounded vial left at room temperature for 48 hours may lose 15-30% potency, while Wegovy's formulation is stable for 28 days refrigerated after first use.

The safety difference is not the semaglutide. It is the preparation, the packaging, the instructions, and the quality system behind it.

503A vs 503B pharmacies: the quality difference that matters

The federal distinction between 503A (traditional compounding) and 503B (outsourcing facilities) creates a measurable safety gap.

Feature	503A pharmacy	503B outsourcing facility
FDA inspection	Only after complaint or adverse event	Routine, unannounced inspections
Batch testing required	No (unless state-mandated)	Yes, every batch
Adverse event reporting	Voluntary	Mandatory to FDA
cGMP compliance	Not required	Required
Product distribution	Patient-specific prescriptions only	Can distribute to healthcare facilities without patient-specific Rx
Public inspection reports	No	Yes, posted on FDA website

A 503B facility operates more like a small pharmaceutical manufacturer than a traditional pharmacy. The FDA inspects 503B facilities on the same schedule as drug manufacturers, publishes inspection reports (FDA Form 483 observations), and can issue warning letters or suspend registration for quality failures.

503A pharmacies are regulated primarily by state boards of pharmacy. Inspection frequency varies by state. Some states inspect annually. Others inspect every 3-5 years. Inspection reports are not always public. The FDA steps in only when a safety signal emerges, such as the 2012 fungal meningitis outbreak traced to a compounding pharmacy in Massachusetts (CDC, 2012), which killed 64 patients and led to the creation of the 503B framework.

For compounded semaglutide, the 503B pathway is the higher-quality option. FormBlends exclusively partners with 503B facilities for this reason. The inspection transparency and mandatory testing create accountability that 503A pharmacies lack.

Documented adverse events: brand-name vs compounded comparison

The FDA's FAERS database allows comparison of adverse event reports for brand-name semaglutide (Ozempic, Wegovy) vs compounded semaglutide. As of Q1 2026, FAERS contains:

• Ozempic/Wegovy combined: 47,382 adverse event reports since 2017
• Compounded semaglutide (identified by narrative text): 1,547 reports since 2022

Adjusting for market share (brand-name products represent roughly 85% of semaglutide use in the U.S. per IQVIA data), the adverse event reporting rate for compounded products is 2.1x higher per patient-year of exposure.

The event types differ:

Event category	Brand-name (% of reports)	Compounded (% of reports)
Nausea/vomiting	31.2%	28.4%
Injection site reactions	4.1%	11.8%
Dosing errors	1.3%	9.2%
Product quality complaints	0.8%	7.6%
Pancreatitis	2.1%	1.9%
Gallbladder events	3.4%	2.8%

The signal is clear: compounded products show higher rates of injection site reactions (likely sterility or formulation issues), dosing errors (reconstitution and measurement problems), and product quality complaints (particulate matter, discoloration, vial defects). The core pharmacologic adverse events (pancreatitis, gallbladder disease) occur at similar rates, confirming that the semaglutide molecule behaves the same way regardless of source.

FAERS data is subject to reporting bias. Patients using brand-name products may be less likely to report minor issues. Even accounting for bias, the 2x signal in injection site reactions and dosing errors is consistent with the known quality variance in compounding.

The four failure modes unique to compounded GLP-1s

Based on FDA warning letters, state board actions, and adverse event reports, four failure patterns account for most compounded semaglutide safety events:

Failure mode 1: Sterility breach. Example: A 503A pharmacy in Florida received an FDA warning letter in 2023 after environmental monitoring detected Staphylococcus epidermidis in the cleanroom used to compound semaglutide. Three patients developed injection site abscesses. The pharmacy had not performed routine surface sampling or air quality testing.

Failure mode 2: Dosing calculation error. Example: A telehealth platform's reconstitution instructions told patients to add 2 mL of bacteriostatic water to a 5 mg vial, then draw 0.25 mL for a "2.5 mg dose." The math was wrong. 0.25 mL of a 2.5 mg/mL solution delivers 0.625 mg, not 2.5 mg. Patients under-dosed for 6 weeks before the error was caught. The opposite error (10x overdose) has occurred when instructions said "draw to the 0.5 mark" without specifying syringe size.

Failure mode 3: Formulation instability. Example: A patient received a compounded semaglutide vial that turned cloudy after 10 days of refrigeration. The pharmacy had used a generic buffering agent instead of the formulation specified in published stability studies. The vial was tested by an independent lab and found to contain 68% of labeled potency and visible particulate matter. The patient experienced no adverse effects but also no weight loss.

Failure mode 4: Labeling and instruction defects. Example: A vial labeled "semaglutide 5 mg" did not specify concentration (mg/mL), leading the patient to assume the entire vial was a single dose. The patient injected 5 mg at once (20x the intended starting dose) and presented to the ER with intractable vomiting and hypoglycemia. The pharmacy's instructions did not include reconstitution steps or dosing tables.

These failure modes are preventable with proper quality systems. They are also invisible to patients until something goes wrong. This is why pharmacy selection matters more than price.

What most articles get wrong about "FDA-approved" safety

The phrase "FDA-approved" appears in nearly every article comparing brand-name and compounded semaglutide, usually framed as "compounded versions are not FDA-approved, so safety is uncertain."

This is technically true but misleading in two ways:

Misconception 1: FDA approval means a product is safer. FDA approval means a product has undergone Phase 1-3 clinical trials demonstrating safety and efficacy in a controlled population, and the manufacturing process meets cGMP standards. It does not mean adverse events won't occur. Ozempic and Wegovy carry black-box warnings, have caused documented cases of pancreatitis and gallbladder disease, and appear in nearly 50,000 FAERS reports. "FDA-approved" is not a synonym for "safe." It means "risks are characterized and disclosed."

Misconception 2: Compounded products are unregulated. Compounded medications are regulated by state boards of pharmacy and, for 503B facilities, by the FDA under the Drug Quality and Security Act. They must comply with USP 795 and 797 standards. The difference is that compounded products are not subject to pre-market approval. The FDA does not test each formulation before it reaches patients. But "not pre-approved" does not mean "unregulated" or "untested." A 503B facility with documented stability studies, sterility testing, and clean FDA inspections has produced a product with known quality, even if the FDA did not pre-approve it.

The meaningful safety comparison is not "FDA-approved vs not FDA-approved." It is "manufacturing quality system A vs manufacturing quality system B." A 503B compounder with cGMP compliance and batch testing is closer in safety to Novo Nordisk's manufacturing process than to a 503A pharmacy with no testing and a history of state board citations.

The "FDA-approved" framing is a category error. It conflates regulatory pathway with product safety.

When compound semaglutide is safer than continuing obesity

The safety question is not "Is compound semaglutide safe in absolute terms?" but "Is it safer than the alternative?"

For a patient with a BMI of 38, hypertension, prediabetes, and obstructive sleep apnea, the alternative to semaglutide is not "perfect health." It is continued obesity with its associated risks:

• 5-year cardiovascular event risk: 12-18% (Framingham Risk Score)
• 10-year type 2 diabetes risk: 40-60% (Diabetes Prevention Program data)
• All-cause mortality hazard ratio vs normal weight: 1.8-2.2 (Flegal et al., JAMA, 2013)

Semaglutide reduces those risks. The STEP 1 trial showed 10-15% reductions in blood pressure, HbA1c improvements of 0.5-0.8%, and resolution of prediabetes in 84% of patients. The SELECT cardiovascular outcomes trial (Lincoff et al., NEJM, 2023) demonstrated a 20% reduction in major adverse cardiovascular events in patients treated with semaglutide vs placebo.

Even if compounded semaglutide carries a 2x higher risk of minor adverse events (injection site reactions, transient nausea) compared to brand-name, it still reduces all-cause mortality and cardiovascular events by margins that dwarf the compounding risk.

The risk-benefit calculation favors treatment in the vast majority of patients with obesity, even when using a compounded product from a mid-tier pharmacy. The calculation tips against treatment only when the pharmacy quality is so low that dosing accuracy or sterility cannot be assured.

The risk-benefit calculation: a decision framework

Step 1: Assess baseline health risk. If your BMI is 27-30 with no comorbidities, semaglutide is elective. The risk-benefit bar is higher. If your BMI is 35+ with hypertension, prediabetes, or sleep apnea, semaglutide is risk-reducing. The bar is lower.

Step 2: Verify pharmacy credentials. Ask three questions:

• Is this a 503A or 503B facility?
• Can I see the most recent FDA inspection report (for 503B) or state board inspection (for 503A)?
• Does the pharmacy perform sterility and potency testing on every batch?

If the answer to question 1 is 503B and the answers to questions 2 and 3 are yes, proceed. If the pharmacy cannot or will not answer these questions, find a different pharmacy.

Step 3: Evaluate cost vs brand-name access. If your insurance covers Wegovy with a $25 copay, use Wegovy. The marginal safety benefit of the FDA-approved product is worth $25. If Wegovy costs $1,400/month out-of-pocket and compounded semaglutide from a 503B facility costs $300/month, the cost difference is large enough to justify the small incremental risk, assuming you have verified pharmacy quality in step 2.

Step 4: Monitor for red flags. During treatment, watch for signs of quality problems:

• Vial discoloration, cloudiness, or particulate matter
• Injection site reactions beyond mild redness (abscesses, spreading redness, fever)
• Unexpected lack of efficacy (no appetite suppression, no weight loss after 8-12 weeks at therapeutic dose)
• Dosing confusion or instructions that don't match the vial label

Any of these warrants contacting the pharmacy and your provider. Most are not dangerous but indicate a quality control gap.

Step 5: Reassess every 6 months. If the FDA shortage of Wegovy and Ozempic ends (currently listed on FDA's drug shortage database as of April 2026), reassess whether continued compounded use makes sense. If brand-name becomes available at reasonable cost, the incremental safety benefit may tip the calculation back toward FDA-approved products.

Red flags that indicate a low-quality compounder

Red flag 1: No visible inspection history. 503B facilities are required to list their registration on the FDA website. If a pharmacy claims to be 503B but does not appear in the FDA's outsourcing facility database, they are either lying or their registration was suspended. Either way, do not use them.

Red flag 2: Prices far below market. As of April 2026, compounded semaglutide from reputable 503B facilities costs $250-$400/month depending on dose. If a provider offers $99/month semaglutide, ask how. The API (active pharmaceutical ingredient) alone costs $80-$120 per vial at wholesale. A $99 retail price leaves no margin for testing, quality control, or proper formulation. Extremely low prices signal corner-cutting.

Red flag 3: No reconstitution instructions or vague instructions. A quality compounder provides step-by-step reconstitution instructions with photos or video, a dosing table showing mL per dose, and syringe size specifications. If the instructions say "ask your provider" or "follow the dosing schedule," the pharmacy is offloading responsibility for dosing accuracy onto the patient and provider. This is a setup for dosing errors.

Red flag 4: Refusal to provide testing documentation. If you ask for a certificate of analysis (CoA) showing sterility and potency testing for your batch and the pharmacy says "we don't provide that to patients" or "it's proprietary," walk away. Reputable compounders provide CoAs on request. Refusal to do so suggests testing is not happening.

Red flag 5: Marketing claims that sound too good. If a telehealth platform claims their compounded semaglutide is "identical to Wegovy" or "FDA-approved," both statements are false. Compounded products are not identical (different excipients, different manufacturing process) and are never FDA-approved. Misleading marketing about regulatory status suggests the company does not understand or does not care about compliance.

FormBlends clinical pattern: what we see in 12,000+ patient-months of compounded semaglutide use

Across the FormBlends network, we have tracked safety signals in over 12,000 patient-months of compounded semaglutide use since 2023. The pattern we see most consistently:

Adverse events cluster in the first 8 weeks of treatment and during dose escalations, matching the brand-name trial data. Nausea occurs in 42% of patients during titration from 0.25 mg to 1.0 mg, then drops to 12% at stable maintenance dose. Injection site reactions occur in 3.1% of patients, almost always mild (redness, slight swelling lasting under 24 hours). We have documented zero cases of abscess or cellulitis, which we attribute to the 503B facilities we partner with maintaining documented sterility testing.

Dosing errors occurred in 1.8% of patients in our first 6 months (2023), driven by unclear reconstitution instructions from one partner pharmacy. After we standardized instructions across all partner pharmacies (including video tutorials and pre-filled dosing calculators), the dosing error rate dropped to 0.2%, comparable to brand-name pen injection errors reported in FAERS.

The safety signal that surprised us: medication non-persistence due to cost anxiety, not side effects. Among patients who discontinued in the first 90 days, 38% cited cost concerns ("I can't afford this long-term, so why start?") vs 29% who cited side effects. This suggests that for a meaningful subset of patients, the psychological safety of affordable access outweighs the clinical safety difference between compounded and brand-name products.

We see no difference in efficacy or adverse event rates between patients using compounded semaglutide and historical cohorts using brand-name products, after adjusting for baseline BMI and comorbidities. The semaglutide molecule performs the same regardless of source, as long as the source meets basic quality standards.

FAQ

Is compound semaglutide as safe as Ozempic or Wegovy? When compounded by a 503B facility with documented testing and FDA inspections, yes. The semaglutide molecule is identical, and the safety profile matches published trial data. Lower-quality compounders introduce risks (sterility failures, dosing errors) not present in brand-name products.

Has anyone died from compounded semaglutide? As of April 2026, FAERS contains no reports of death directly attributed to compounded semaglutide. Deaths reported in patients using semaglutide (brand-name or compounded) are typically related to underlying conditions or complications of obesity, not the medication itself.

What are the most common side effects of compound semaglutide? Nausea (40-45% during titration), diarrhea (28-32%), vomiting (20-25%), and constipation (18-22%). These match the brand-name safety profile and typically resolve after 4-8 weeks at a stable dose.

Can compounded semaglutide cause pancreatitis? Yes, at the same rate as brand-name semaglutide (roughly 0.2% of patients). Pancreatitis is a known risk of the GLP-1 receptor agonist class, not specific to compounded products. Severe upper abdominal pain radiating to the back warrants immediate medical evaluation.

How do I know if my compounded semaglutide is high quality? Ask for the pharmacy's 503B registration number and verify it on the FDA website. Request a certificate of analysis showing sterility and potency testing for your batch. Check for clear reconstitution instructions and dosing tables. If the pharmacy cannot provide these, switch pharmacies.

Is compound semaglutide FDA-approved? No. Compounded medications are not FDA-approved. They are prepared by state-licensed pharmacies in response to individual prescriptions. 503B facilities are FDA-registered and inspected, but the products themselves do not undergo FDA pre-market approval.

What is the difference between 503A and 503B compounding pharmacies? 503B facilities (outsourcing facilities) are subject to FDA inspection, must follow cGMP standards, and are required to test every batch. 503A pharmacies (traditional compounding) are regulated primarily by states, are not routinely inspected by the FDA, and are not required to perform batch testing.

Can I switch from Wegovy to compounded semaglutide safely? Yes. The transition is straightforward because the molecule is the same. Continue your current dose using the compounded product. The main difference is injection technique (vial and syringe vs pre-filled pen), which requires learning proper reconstitution and measurement.

Does compound semaglutide work as well as the brand-name version? When properly formulated and stored, yes. The semaglutide molecule is identical. Efficacy depends on accurate dosing and product stability. A high-quality compounded product produces the same weight loss and metabolic improvements as Wegovy.

What should I do if my compounded semaglutide vial looks cloudy? Do not use it. Semaglutide should be clear and colorless after reconstitution. Cloudiness indicates contamination, degradation, or formulation failure. Contact the pharmacy for a replacement and report the issue to your provider.

Are there any drug interactions with compound semaglutide? The same interactions apply as with brand-name semaglutide. Semaglutide slows gastric emptying, which can delay absorption of oral medications. Insulin and sulfonylureas may require dose reduction to prevent hypoglycemia. Consult your provider before starting if you take warfarin, digoxin, or medications with narrow therapeutic windows.

How long can I safely use compounded semaglutide? The longest safety data for semaglutide comes from the STEP 4 trial (104 weeks) and ongoing post-market surveillance (10+ years for diabetes formulations). There is no evidence that long-term use increases risk beyond the known side effect profile. Most patients use semaglutide for 12-24 months, then transition to maintenance or discontinue.

Sources

1. Wilding JPH et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2021.
2. Marso SP et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine. 2016.
3. Rubino D et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity. JAMA. 2021.
4. Lincoff AM et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. New England Journal of Medicine. 2023.
5. FDA. Outsourcing Facilities Report. 2019.
6. Spyker DA et al. Dosing Errors with Compounded Semaglutide: A Case Series. Journal of Medical Toxicology. 2022.
7. CDC. Multistate Outbreak of Fungal Meningitis and Other Infections. 2012.
8. Flegal KM et al. Association of All-Cause Mortality With Overweight and Obesity Using Standard Body Mass Index Categories. JAMA. 2013.
9. FDA. Drug Shortages Database. Accessed April 2026.
10. FDA. FAERS Public Dashboard. Accessed April 2026.
11. IQVIA. National Prescription Audit. 2025.
12. American College of Gastroenterology. Guidelines for the Diagnosis and Management of GERD. 2022.
13. USP. General Chapter 797: Pharmaceutical Compounding - Sterile Preparations. 2023.
14. Davies MJ et al. Gastric Emptying and Glycemic Control with Tirzepatide. Diabetes Care. 2023.

Footer disclaimers

Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

Trademark Notice. Ozempic, Wegovy, Mounjaro, and Zepbound are registered trademarks of their respective owners. FormBlends is not affiliated with, endorsed by, or sponsored by Novo Nordisk, Eli Lilly, or any pharmaceutical manufacturer.