The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro.

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from Fullerton Wellness had an unidentified "black particulate" floating in it. Semaglutide, like tirzepatide, is injected under the skin and is intended to be sterile.

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Amid ongoing legal battles over coveted GLP-1 therapies, a drug vendor in Washington state is accused of running an outlandish scheme to sell do-it-yourself kits to make illicit knockoff versions of weight-loss and diabetes drugs, Zepbound and Mounjaro.

For the alleged scheme, vendor Pivotal Peptides has customers buy a set of ingredients they have to mix together to create their own injectable versions of the drugs. Customers don't need a prescription or even a medical consultation to order the kit, even though the brand-name drugs are prescription-only. That may not be surprising, though, since the dubious white powder customers receive is stated to be "a research chemical for lab research and veterinary purposes only." Once purchased, the kit's instructions recommend users disinfect their home work surface before beginning and stress the importance of using the sterile water included in the kit to dissolve the powder to the desired concentration. The instructions then explain how to inject oneself with the homemade mixture using a 30-gauge syringe.

That's all according to a lawsuit filed Monday by pharmaceutical giant Eli Lilly, maker of tirzepatide-based Zepbound and Mounjaro, which are sold as ready-to-use medicines in single-dose pens or vials. The lawsuit against Pivotal Peptides is one of three that Lilly filed this week, all accusing questionable drugmakers of unlawfully selling knockoff versions of its tirzepatide drugs that have not been tested or approved. But the one against Pivotal Peptides stands out for the scheme the owners allegedly used to sell their knockoff version.

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Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug's effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that's where it remained until last week.

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Hurricane Helene's catastrophic damage and flooding to the Southeastern states may affect the country's medical supply chain.

Hospitals nationwide are bracing for a possible shortage of essential intravenous fluids after the cataclysmic storm inundated a vital manufacturing plant in North Carolina.

The plant is Baxter International's North Cove manufacturing facility in Marion, which is about 35 miles northeast of Asheville. Helene unleashed unprecedented amounts of rain throughout the western part of the state, killing dozens and ravaging numerous communities, homes, and other structures, including the plant.

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Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. (credit: Getty | helby Knowles)

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company's press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month's supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month's supply of vials with the 2.5 mg doses will cost $399, while a month's supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

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Enlarge (credit: Olga Pankova/Moment via Getty Images)

In 2019, an agency within the US Department of Defense released a call for research projects to help the military deal with the copious amount of plastic waste generated when troops are sent to work in remote locations or disaster zones. The agency wanted a system that could convert food wrappers and water bottles, among other things, into usable products, such as fuel and rations. The system needed to be small enough to fit in a Humvee and capable of running on little energy. It also needed to harness the power of plastic-eating microbes.

“When we started this project four years ago, the ideas were there. And in theory, it made sense,” said Stephen Techtmann, a microbiologist at Michigan Technological University, who leads one of the three research groups receiving funding. Nevertheless, he said, in the beginning, the effort “felt a lot more science-fiction than really something that would work.”

That uncertainty was key. The Defense Advanced Research Projects Agency, or DARPA, supports high-risk, high-reward projects. This means there’s a good chance that any individual effort will end in failure. But when a project does succeed, it has the potential to be a true scientific breakthrough. “Our goal is to go from disbelief, like, ‘You're kidding me. You want to do what?’ to ‘You know, that might be actually feasible,’” said Leonard Tender, a program manager at DARPA who is overseeing the plastic waste projects.

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Enlarge / An adult Thelazia callipaeda in the eye of a cat.

In a battle of bear versus exotic eye worm, the eye worm wins—and that's bad news for all of us.

Researchers on Wednesday reported the first known infection of an exotic eye worm in a black bear in the US, which was killed in Pennsylvania in November 2023. The bear had at least 13 adult parasitic worms pulled from its eyes, and the researchers identified them as the invasive, potentially blinding species Thelazia callipaeda, which was only first detected in the US in 2020.

The bear's infection shows that the worm is rapidly expanding both its range of potential hosts as well as its geographic foothold in the US. In all, the finding "implicates exposure and risk for transmission to threatened and endangered species and direct or indirect risk for transmission to humans and domestic animals," write the researchers, led by veterinary experts at the University of Pennsylvania. Their report appears today in the journal Emerging Infectious Diseases.

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Updated risk indicators, and the “If you decide to travel” section.

Do not travel to Libya due to crime, terrorism, unexploded landmines, civil unrest, kidnapping, and armed conflict.

Country Summary: Crime levels in Libya remain high, including the threat of kidnapping for ransom. U.S. citizens have been targets of these crimes.

Terrorist groups are present in Libya. No terrorist incidents that involved foreigners have been publicly reported in Libya since 2015.  Nevertheless, terrorist attacks could occur with little or no warning, targeting public spaces like tourist locations, hotels, transportation hubs, markets/shopping malls, and government facilities.

Kidnapping is widespread, and victims have included U.S. citizens. Kidnappers may take advantage of unplanned opportunities. Criminal or armed individuals or groups have threatened to and/or have seized or detained and threatened to kill, injure, or continue to detain individuals in order to compel a third party (including a governmental organization) to do or abstain from doing something as a condition of release.

Unexploded landmines, cluster munitions, and unexploded ammunition are a hazard throughout Libya. Heed land mine warning signs. Do not venture off the road into areas marked with red and white plastic tape. Avoid roadside ditches, shoulders, and unmarked trails. Never touch anything resembling unexploded munitions. Landmines do exist in populated areas due to numerous ground offensives in the last decade.

Outbreaks of violence between competing armed groups can occur with little warning and have the potential to impact U.S. citizens. The capital, Tripoli, and other cities, such as Surman, Al-Jufra, Misrata, Ajdabiya, Benghazi, and Zuwara, have witnessed fighting among armed groups. Hotels and airports frequented by U.S. citizens have been the targets of these attacks. Even demonstrations intended to be peaceful can turn confrontational and escalate into violence.

Armed groups sometimes detain travelers for arbitrary reasons, do not grant detainees access to a lawyer or a legal process, and do not allow detainees to inform others of their status. U.S. citizens should carry proof of citizenship and valid immigration status at all times, but having these documents does not guarantee fair treatment.

 While there are operational international airports in Libya with regular domestic and international flights, flights are often delayed, rerouted, and cancelled without warning.  The U.S. government prohibits U.S. commercial aviation operations within Libyan airspace.

Due to risks to civil aviation operating within or in the vicinity of Libya, the Federal Aviation Administration (FAA) has issued a Notice to Air Missions (NOTAM) and/or a Special Federal Aviation Regulation (SFAR). For more information U.S. citizens should consult the Federal Aviation Administration’s Prohibitions, Restrictions and Notices.

The Commandant of the U.S. Coast Guard has determined that effective anti-terrorism measures are not in place in Libyan ports and has imposed conditions of entry on vessels that arrive in U.S. ports having visited ports in Libya. Mariners and passengers traveling through the ports of Libya should exercise caution.

The U.S. government has limited ability to provide emergency or routine assistance to U.S. citizens in Libya, as the U.S. Embassy in Tripoli suspended its operations in July 2014.

U.S. citizens in Libya in need of routine consular services should contact the U.S. Embassy in Tunis, Tunisia for assistance. To contact the U.S. Embassy in Tunis, click here.

U.S. citizens who are in Libya are urged to depart as soon as possible via commercial means if possible. U.S. citizens who are seeking U.S. government assistance to depart should email complete biographic details and contact information (email and phone number), as well as U.S. passport number, to TunisACS@state.gov.

The Department of State will continue to provide information via the Smart Traveler Enrollment Program (STEP), Embassy Libya's web page, Travel.State.Gov, Facebook, and Twitter/X.

Read the country information page for additional information on travel to Libya.

If you decide to travel to Libya:

• Visit our website for Travel to High-Risk Areas.
• Carry proof of citizenship and valid immigration status at all times.
• Avoid demonstrations and crowds.
• Make contingency plans to leave.
• Draft a will and designate appropriate insurance beneficiaries and/or a power of attorney.
• Discuss a plan with loved ones regarding care/custody of children, pets, property, belongings, non-liquid assets (collections, artwork, etc.), funeral wishes, etcetera.
• Establish your own personal security plan in coordination with your family, and employer or host organization, so that they can monitor your safety and location. This plan should specify whom you would contact first, and how that person should share information.
• Appoint one family member to serve as the point of contact with kidnappers/hostage-takers, media, U.S. and host country government agencies, and members of Congress if you are kidnapped, taken hostage, or detained.
• Consider consulting with a professional security organization.
• Do not touch unknown metal objects and avoid traveling off well-used roads, tracks, and paths due to risk of unexploded ordnance.
• Enroll in the Smart Traveler Enrollment Program (STEP) to receive Alerts and make it easier to locate you in an emergency.
• Review the Country Security Report for Libya.
• Follow the Department of State on Facebook and X/Twitter.
• Visit the CDC page for the latest Travel Health Information related to your travel.
• U.S. citizens who travel abroad should always have a contingency plan for emergency situations. Review the Traveler’s Checklist.