FDA’s Weight Loss Drug ‘No Man’s Land’ Adds Risk for Compounders

Pharmacies currently making copycat versions of Eli Lilly’s tirzepatide face heightened exposure to state enforcement actions and legal challenges while the FDA reconsiders whether or not there is a shortage of the weight loss drug.

The Food and Drug Administration’s decision to reassess Eli Lilly & Co.'s capacity to produce tirzpeatide—a diabetes and obesity treatment branded as Mounjaro and Zepbound—is pressuring compounding pharmacies to weigh the risks of producing versions of the drug while the agency deliberates.

The FDA’s reassessment comes after the agency was hit with a lawsuit this month from the Outsourcing Facilities Association and compounding pharmacy FarmaKeio Custom Compounding challenging its determination that the shortage was resolved. The FDA then asked a federal court to remand the decision to the agency for reconsideration, which it was granted Oct. 11.

The FDA has since said it won’t take action against compounders, but life science attorneys say the agency’s reconsideration period leaves the door open for risks for the pharmacies producing compounded versions of the drug.

State pharmacy boards, which oversee compounding pharmacies, could still take enforcement action as long as tirzepatide remains off the shortage list website.

Eli Lilly has also ramped up its challenges against online vendors and medical spas selling unauthorized versions. The manufacturer filed its latest round of lawsuits against three vendors on Oct. 21.

“There’s still a gray area because some states are relying on the shortage list itself to determine whether or not some practices are allowed,” said Courtney Sullivan, an attorney at Boesen & Snow LLC. “The FDA created this no man’s land where pharmacies are left to weigh what their individual risk is and whether or not they think they are willing to take that risk.”

Tirzepatide has been in shortage since 2022 due to increased demand. Traditional compounding pharmacies and outsourcing facilities have produced copies of the drug to meet the demand.

The FDA on Oct. 2 said it confirmed with Eli Lilly that availability and manufacturing capacity for tirzepatide can meet the present and projected demand, but compounders argue the shortage still remains.

Still Off The List

The FDA’s recent move to confirm that it won’t take enforcement action against tirzepatide compounders outside of the Outsourcing Facilities challenge was a win for the compounding industry.

The clarification was sent in an Oct. 17 letter to the Alliance for Pharmacy Compounding (APC), which responded to the group’s emergency request to spell out whether all outsourcing facilities and state-licensed pharmacies can resume compounding of tirzepatide pursuant to all relevant existing laws and regulations.

While the FDA says it won’t take enforcement action during this period, “its decision does not mean state boards of pharmacy will take the same approach,” APC’s CEO, Scott Brunner, said in a statement.

“We would hope most states would follow FDA’s lead, but we strongly urge pharmacies to check with their state board of pharmacy before they recommence compounding copies of tirzepatide injection,” Brunner said.

Tirzepatide injections still remain off of the FDA’s drug shortage list website, which could force pharmacy boards to heighten oversight against compounding against pharmacies, attorneys say. This can include warning letters, product seizures, or injunctions.

Section 503A of the Federal Food, Drug, and Cosmetic Act restricts compounded drugs that are essentially copies of commercially available drugs, but certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts,” according to the FDA. A drug is not considered to be commercially available if it is on FDA’s drug shortages list.

Outsourcing facilities are restricted from making essentially a copy of an FDA-approved drug, but the limitation is lifted if the drug is on the shortages list.

The National Association of Boards of Pharmacy, an independent group assisting state boards of pharmacy, said individual state boards set standards and rules that govern pharmacy service providers for their residents.

Some state boards have signaled where they stand with compounding tirzepatide at this time.

Arizona’s Board of Pharmacy on Oct. 17 in a regular board meeting said it won’t take action against pharmacies compounding this drug during this period. A spokesperson for the Colorado State Board of Pharmacy said the board was in receipt of the FDA’s guidance and evaluates all complaints on a case by case basis.

A spokesperson for the Kansas Board of Pharmacy said it has yet to discuss this issue, but in past similar situations where the FDA has indicated it will exercise enforcement discretion, the board mirrored it at the state level. “Ultimately, our mission is to protect the public and ensure patients have continued and safe access to necessary medications,” the spokesperson said.

“Our position is that FDA needs to put tirzepatide back on the formal shortage list pending this reevaluation, because without that, pharmacies are forced to decide whether or not this is a risk that they want to take on, and that’s not fair to their patients,” Sullivan said.

Lilly’s Legal Saga

Pharmacies could also face other risks outside enforcement actions, attorneys say.

“There are still risks—not just from FDA enforcement risk but also litigation risk stemming from the manufacturers,” said Dae Y. Lee, partner in Frier Levitt’s life sciences department. “Manufacturers, like Lily, may start pursuing legal action against the compounding business.”

A Lilly spokesperson said the company will continue to pursue appropriate legal avenues against compounders. The company also calls upon “state and federal regulators to also take steps to stop the mass-manufacture, marketing, and sale of unapproved drugs.”

The manufacturer filed lawsuits Oct. 21 in federal courts in Indiana, Texas, and Washington. The suits, which named Pivotal Peptides LLC, Mangoceuticals Inc., and Genesis Lifestyle Medicine of Nevada LLC, brought claims alleging false advertising promotion and violation of state consumer protection acts.