NABP’s accreditations and inspections provide a unique opportunity to observe drug safety issues from a national perspective in both pharmacy practice and drug distribution. Through the processing of accreditation applications of digital pharmacies and drug wholesale distributors, we have recently observed schemes involving nonprescription insulin that pose important health threats to patients. While these pharmacies and wholesalers cannot become NABP accredited until corrective measures have been taken and they have ceased such activities, these schemes continue to threaten patients in non-accredited facilities. We hope that creating awareness of these activities will help prevent serious health complications for diabetic patients, who have a lifetime challenge of managing a very serious disease. 

How Insulin Is Regulated and Should Be Handled  

As you would expect, diabetes medications typically require a prescription; however, there is an exception for some older forms of insulin. These nonprescription insulins, which are still widely used, can be purchased without a prescription. In fact, they remain the only injectable human drugs that can be sold without a prescription under federal law.   

Diabetes advocacy groups, such as the American Diabetes Association, support the availability of nonprescription insulin, which is an important treatment option for diabetes patients who lack or have inadequate insurance to help with the high cost of prescription treatment options. Although these types of insulin are not displayed in the over-the-counter (OTC) section of the store, they can legally be sold upon request to patients who do not present a prescription from an authorized prescriber. In this situation, the pharmacist is an important frontline resource for diabetics. 

Some types of insulin can be sold without a prescription because they were “grandfathered in.” Insulin products that fall within this category were on the market prior to the enactment of the Federal Food, Drug, and Cosmetic Act in 1938, which required certain drugs be classified as “legend” or “prescription” drugs.  

Nonprescription forms of insulin are not subject to the same supply chain regulations in federal and state law as prescription insulin is. According to NABP’s 2021 Survey of Pharmacy Law, only 15 states require a license for the wholesale distribution of OTC drugs, which includes nonprescription insulin. Indiana was the only state requiring a prescription for the sale of all insulin products until that law was repealed in 2020. Nonprescription insulin is not subject to traceability requirements that are part of the federal Drug Supply Chain Security Act of 2013 (Title II of the Drug Quality and Security Act). This law was intended to protect the integrity of drugs from adulteration and counterfeiting by implementing requirements for traceability and other protections.  

Insulins are complex biological products that are sensitive to temperature variations. As such, manufacturers recommend that insulin be stored in refrigerated conditions (36o-46oF). At these temperatures, insulin will retain its potency through the labeled expiration date. Once opened, insulin will continue to work for up to 28 days at room temperature (59o-86oF). Insulin can degrade and lose potency when exposed to extreme temperatures, either freezing temperatures or high heat. 

Scheme Exploits Insulin Laws

To make nonprescription insulin more accessible to patients, one of the top manufacturers of insulin began working with community pharmacy chains. In these partnerships, the manufacturer produces a line of insulin products exclusively for the chain. The private label insulin is labeled to indicate that the product can only be sold by the chain (eg, “ONLY FOR RETAIL SALE BY [COMPANY NAME] AND ITS AFFILIATES.”) The drug’s retail price for patients is often below the wholesale price of other insulin products sold to pharmacies.  

Criminals posing as patients purchase this insulin at the retail pharmacies, collect it in large quantities, and resell it into the wholesale market. Wholesalers purchase this “diverted” insulin and resell it to retail pharmacies and, in some cases, to other wholesalers. This deliberate scheme to subvert the regulated supply chain is exposing patients to the high risk of receiving an adulterated drug in the form of subpotent insulin. 

To combat this nationwide problem, Georgia enacted a law that criminalizes the resale of nonprescription insulin that a patient first obtained through an OTC sale. Insulin sold in this manner is deemed adulterated under the law. 

NABP became aware of this scheme when inspecting a pharmacy that specified that insulin purchased by its facility was collected from several of the chain’s pharmacies over a single weekend. This scheme was carried out by an organized group that sold the purchased insulin to a wholesale distributor, which then sold it to a mail-order pharmacy. Upon further investigation, we discovered that this is the typical pathway in which diverted insulin is resold into the marketplace. 

The risks with this type of corrupt distribution are very high for patients, as they are receiving and injecting potentially adulterated insulin that is very likely subpotent. The storage and handling of this diverted insulin are completely unknown to patients and should be questioned by distributors.   

Maintain your awareness of these types of schemes and verify the source of insulin for retail pharmacies and drug wholesale distributors before purchasing. Pharmacies that turn a blind eye to the purchase and sale of insulin that is clearly labeled as being exclusively for sale by a specific pharmacy cannot claim ignorance of the source of the diverted insulin.   

NABP’s Drug Distributor Accreditation and OTC Medical Device Distributor Accreditation play a pivotal role in preventing counterfeit drugs and devices from entering the United States medical supply. You can help, too: Talk to patients about the importance of purchasing insulin and other medications from an accredited pharmacy.