You may have seen news articles where the manufacturers of approved popular weight loss

drugs urge the Food and Drug Administration (FDA) to stop allowing compounded versions of

glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to be sold online.1 They allege that

these medications are “too complex to be copied” and that compounded versions have been

linked to multiple serious adverse events.¹ In light of this controversy, it is our responsibility as

pharmacists to be well informed regarding the latest FDA updates in order to protect the public

from harm. 

GLP-1 Receptor Agonists and Their Use

Glucagon-like peptide-1 receptor agonist medications are approved by the FDA for the

management of type 2 diabetes and obesity. These medications work by mimicking the GLP-1

hormone that plays a crucial role in regulating insulin production and lipid metabolism.² They

work by stimulating the pancreas to secrete insulin in response to ingesting a meal and, in

turn, lowering glucose levels in the blood.² In addition, GLP-1 RAs delay gastric emptying and

reduce food intake through central appetite suppression, which leads to patient weight loss.³

Most GLP-1 RAs are weekly subcutaneous injections that are largely convenient for patients

and easy to use. Due to their ability to cause weight loss in patients with or without diabetes,

there was a large increase in the demand for these medications, resulting in their inclusion in

the FDA’s official drug shortage list.⁴ This led to companies looking for solutions so that they

can make a profit while supplying patients with medications that are in high demand. Many of

these companies have begun compounding their own GLP-1 RAs without FDA approval and

dispensing them to patients without properly and clearly explaining the risks involved.

Concerns Regarding the Use of Compounded GLP-1 Receptor Agonists

According to the FDA, compounded drugs are used when the patient presents the need for a

treatment that cannot be met by an FDA-approved medication because of allergies to

dyes/excipients, inability to swallow, and drug shortages.⁵ The article then states that

compounded drugs are not FDA-approved medications, indicating they have not gone through

their rigorous approval process for verification of safety, effectiveness, and quality.5 The

challenge in receiving GLP-1 RAs through many of the online sources is the lack of information

provided to the patients with regards to dosing, product composition, side effects, and proper

use. FDA-approved medications must come with detailed dosing instructions and follow quality

control measures that ensure the accurate composition of the product. Compounded

medications that are not approved by the FDA do not have these requirements.

Another concern with the compounded GLP-1 RAs is the use of salt forms of the FDA-

approved products, such as semaglutide acetate or tirzepatide sodium. There is no information

available as to whether these salt forms have the same chemical and pharmacological

properties as the approved drugs. Therefore, there is no guarantee that these medications are

providing the intended effects with similar long-term risks and benefits. Using salt forms could

also lead to dosing errors, resulting in hospitalizations and serious side effects. The federal law

states that the active pharmaceutical ingredient (API) in any medication compounded due to a

drug shortage must be FDA-approved and these salt forms are not.⁶

Adverse Effects

As of August 31, 2024, the FDA has received reports of adverse events related to

compounded GLP-1 RAs, including 346 reports for compounded semaglutide and 136 reports

for compounded tirzepatide.⁷ According to the FDA, the most common reported adverse

effects are due to the overdosing of compounded GLP-1 RAs. The symptoms of overdose

include “gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache,

migraine, dehydration, acute pancreatitis, and gallstones.”⁸ The majority of the cases

pertaining to overdosing involved administering the incorrect dose as a result of inadequate

patient education. Other cases involved provider error when calculating the intended dose due

to incorrect conversion of milligrams into units. The remaining cases reported by the FDA were

related to the different concentrations available of the compounded drugs. Overdosing is not

usually seen with FDA-approved GLP-1 RAs because they are currently only available in pre-

filled pens and are dosed in milligrams with fixed concentrations. The compounded drugs are

dispensed in multi-use vials containing different concentrations.⁸

How Pharmacists Can Help

Due to the potential dangers of using compounded GLP-1 RAs available on the market today,

it is imperative that pharmacists stay vigilant and continue to be ready to educate patients. It is

crucial that pharmacists are able to identify when a patient is taking or considering taking an

unauthorized salt form of a GLP-1 RA. Patients should be counseled to discontinue use and

the pharmacist report the unauthorized product to the FDA immediately via the MedWatch

Program including any side effects the patient experienced.⁷ If patients have questions 

regarding safety, it is important to verify the dosing amount and frequency that the patient is

taking or considering taking, as these are common errors related to misuse of compounded

GLP-1 RAs. The FDA encourages healthcare providers and compounders to supply patients

with appropriate syringe sizes for their intended doses, and to educate them on proper

measurement techniques.8 Furthermore, the patient should be educated on the symptoms of

overdosing and instructed that these symptoms must result in the discontinuation of use and a

visit to their primary care provider. If symptoms are serious or life threatening, they must go to

the emergency room immediately.

Another substance that the pharmacist should be aware of is retatrutide. It is a GLP-1,

glucose-dependent insulinotropic polypeptide (GIP), and glucagon receptor agonist that is

currently under clinical trial for patients with obesity and cardiovascular disease. It is important

to let the patient know that the compounding of retatrutide is illegal, as the API has not been

approved by the FDA as safe and effective for any condition in any form. It is not

recommended that patients inject retatrutide.⁷

With regard to other compounded GLP-1 RAs, pharmacists can visit the FDA Drug Shortage

list4 and counsel the patient as to whether this medication needs to be compounded anymore.

If it is not on the shortage list and does not have to be compounded, patients can receive a

prescription for the brand name product and obtain it from their preferred pharmacy, which is

safer and more regulated for patient use. The FDA was also made aware of counterfeit

Ozempic® being sold through online sources. When patients receive Ozempic® through their

preferred community pharmacy, the risk of obtaining counterfeit drugs is eliminated.⁷

Patients receiving the compounded GLP-1 RAs are often not healthcare professionals, so

things that seem obvious or clear to a pharmacist’s trained eye are not always obvious or clear

to everyone. Most of the companies that sell these medications (For Hims©, For Hers©, Levity©,

Henry Meds©, and many more), use the GLP-1 RA brand names multiple times throughout

their website and even offer for patients to buy the brand name at up to 10 times the price of

the compounded product.^9-12 With proper counseling, patients have the ability to make a more

informed and educated decision for their health and if the reward will be greater than the risk.

References

1. Wingrove P. Novo Nordisk asks US to stop compounding pharmacies from making

weight-loss drug copies. Reuters. Available from:

https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-asks-us-

stop-compounding-pharmacies-making-weight-loss-drug-copies-2024-10-23/. Accessed

November 14, 2024.

2. Alfaris N, et al. “GLP-1 single, dual, and triple receptor agonists for treating type 2

diabetes and obesity: A narrative review.” eClinicalMedicine, vol. 75, 30 Aug. 2024, p.

102782, https://doi.org/10.1016/j.eclinm.2024.102782.

3. Collins L, Costello RA. Glucagon-like peptide-1 receptor agonists. [Updated 2024 Feb

29]. In: StatPearls. StatPearls Publishing; 2024 Jan-. Available from:

https://www.ncbi.nlm.nih.gov/books/NBK551568/#.

4. “Drug shortages.” FDA. Available from: https://dps.fda.gov/drugshortages. Accessed

October 21, 2024.

5. Center for Drug Evaluation and Research. “Compounding and the FDA.” U.S. Food

and Drug Administration, FDA. Available from: https://www.fda.gov/drugs/human-drug-

compounding/compounding-and-fda-questions-and-answers. Accessed October 21,

2024.

6. “Product under section 503A of the federal Food, Drug, and Cosmetic Act.” U.S. Food

and Drug Administration, FDA. Available from:

https://www.fda.gov/files/drugs/published/Compounded-Drug-Products-That-Are-

Essentially-Copies-of-a-Commercially-Available-Drug-Product-Under-Section-503A-of-

the-Federal-Food--Drug--and-Cosmetic-Act-Guidance-for-Industry.pdf. Accessed

October 21, 2024.

7. Center for Drug Evaluation and Research. “FDA’s concerns with unapproved GLP-1

drugs used for weight loss.” U.S. Food and Drug Administration, FDA. Available from:

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-

providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss. Accessed October

23, 2024.

8. Center for Drug Evaluation and Research. “FDA alerts health care providers,

compounders of dosing errors.” U.S. Food and Drug Administration, FDA. Available

from: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-

providers-compounders-and-patients-dosing-errors-associated-compounded. Accessed

October 23, 2024.

9. “Weight loss treatments for men.” For Hims. Available from:

https://www.hims.com/weight-loss. Accessed October 24, 2024.

10. “Weight loss treatments for women.” For Hers. Available from:

https://www.forhers.com/weight-loss. Accessed October 24, 2024.

11. “GLP-1 online weight management.” Henry Meds. Available from:

https://henrymeds.com/glp-1-weight-management/. Accessed October 24, 2024.

12. “Lose weight and keep it off.” Levity. Available from: https://www.joinlevity.com/.

Accessed October 24, 2024.