Lidocaine shortage FAQs

There are three roots causes that are directly contributing to the current lidocaine shortage.

1. COVID-19 (Pandemic): Increased demand for anesthetics to help alleviate the pain of intubated COVID-19 patients depleted the existing supply of lidocaine. In addition, the supply chain shifted to prioritize manufacture and distribution of the COVID-19 vaccine.

2. Manufacturers: The FDA has strict quality control requirements for manufacturers, especially for anesthetics such as lidocaine where errors can prove fatal. This makes it difficult to quickly add new manufacturing capacity when a shortage occurs.

3. Supply Chain: Many factors contribute to supply chain disruptions including increased demand, quality standards and/or problems, and shifting priorities due to such issues as the pandemic or other natural disasters. In the case of lidocaine, all of these likely contributed to the current supply chain troubles.

As a part of the AADA’s ongoing advocacy to address the lidocaine shortage, AADA Regulatory Policy Committee Chair and Drug Shortage Workgroup Chair Eric Millican, MD, FAAD, and AADA staff met with the FDA’s Office of Drug Shortage to share AADA members’ concerns with the ongoing lidocaine and lidocaine with epinephrine shortages.

During the call, the FDA briefed the Academy on the agency’s efforts to address the shortages and stated that the FDA regularly speaks with manufacturers. Based on what manufacturers are reporting, FDA staff indicated their belief that AADA members should expect relief from the shortage by late 2023 or early 2024. The FDA is also exercising its regulatory authority to mitigate the shortages, including encouraging other lidocaine manufacturers to enter the market, expediting applications for increased production lines for current manufacturers, and reaching out to foreign manufacturers, among other options.

Last month, AADA staff also met with lidocaine drug manufacturers Fresenius Kabi and Pfizer to discuss the lidocaine and lidocaine with epinephrine shortages. The manufacturers shared that there is an increased demand for lidocaine and that they expect to see relief in late 2023. Pfizer and Fresenius Kabi provide regular updates on the availability of their drugs.

We have connected with the Alliance for Pharmacy Compounding (APC) to assist members in finding a local pharmacy (both 503A and 503B facilities) that is licensed and compounds lidocaine products. Please visit APC’s find a compounder resource page.

In light of the national lidocaine shortage, the best option is for you to continue to work closely with your current supplier and secondary distributor/supplier. If you do not have a trusted supplier currently, we encourage our members to utilize the AAD Member Buying Program, a member benefit designed to lower medical and office supply costs. It can allow members to place lidocaine orders with existing manufacturers and distributors at a potentially lower price.

The Academy knows how severely the current lidocaine and lidocaine with epinephrine shortage is affecting you and your patients and practices. That is why we are actively working to identify the root causes of the shortage and to develop solutions to mitigate future supply issues. And we’ve worked this issue from every angle.

• AADA Compounding Workgroup Chair Seemal R. Desai, MD, FAAD, has ensured that the consequences of this problem for patients are expressed to the FDA Compounding Workgroup at its meetings in both June 2022 and June 2023.

• The AADA also formed a Drug Shortage Workgroup, chaired by Eric Millican, MD, FAAD, who joined AADA staff in meeting with the FDA’s Office of Drug Shortage to share AADA members’ concerns with the ongoing shortages.

• We met with the manufacturers, Fresenius Kabi and Pfizer, in February 2023. Both manufacturers noted a significant increase in demand and estimated relief by late 2023.

• We’ve worked with our partners in the house of medicine, sending a joint letter to the FDA with ACMS, ASDSA, and ASMS expressing our concern and urging the FDA to take immediate action by adding lidocaine and lidocaine with epinephrine to the “List of Extended Use Dates to Assist with Drug Shortages.” We’ve also joined the End Drug Shortage Alliance to collaborate with other stakeholders on identifying solutions to resolving the supply change challenges and ending drug shortages.

• And on the legislative front, the AADA has supported the Patient Access to Urgent-Use Pharmacy Compounding Act, which would improve access to compounded drugs for in-office use and improve access to medications during drug shortages. In May 2023, AADA submitted a written statement for the record to a congressional subcommittee investigating the root causes of drug shortages.

For more details on AADA advocacy efforts, visit our page on dermatologic drug shortages.

The AAD Member Buying Program, a member benefit designed to lower medical and office supply costs, can help minimize the risk of price gouging. Members are also encouraged to work with a reputable national supplier / distributor; the member buying program cautions that some suppliers may charge five to six times more, but these suppliers do not have a long-term supply.

One of the actions the AADA is taking in assisting with the concerns of the lidocaine shortage is to collaborate with the ACMS, ASDSA, and ASMS to request the FDA add lidocaine and lidocaine with epinephrine to the “List of Extended Use Dates to Assist with Drug Shortages.” Drugs on this list are based on manufacturer stability data that is reviewed by FDA to ensure the drug can sustain its appropriate medical properties when extending its shelf life. 

Manufacturers are updating the FDA on a dose and delivery availability in almost real-time. We find that the ASHP has an up-to-date listing.

Under current FDA rules, physicians and other providers may not import lidocaine directly from Canada for purposes of administrating to patients. The FDA does provide guidance regarding when patients may personally import lidocaine from Canada and bring it to their physician’s office for administration for serious conditions. While “Serious Condition” is not explicitly defined by the FDA for this circumstance, skin cancer likely qualifies as a serious condition. Please note, the AAD cannot provide legal advice to its members so this information is being provided for educational purposes only; individual physicians must make independent judgments about how to proceed in this area. For specific questions or individual cases, we encourage members to speak with their legal counsel and malpractice carrier.

Medications from veterinarian supply chains are NOT approved for human use and should not be used. However, lidocaine products sold for dental use are approved and can be used by physicians in the same manner as lidocaine from your regular suppliers. As with any situation where you use medication from a new supplier, it is important to be aware of any differences with these products — including medication concentrations, preservatives, and packaging in individual vs multi-use vials.

Therefore, members are urged to check the package insert before using alternative sources to verify the concentration, presence or absence of preservatives, and indicated uses. Be aware that using some alternative sources for dermatologic procedures may be considered off-label use.

For more information and to learn more about AADA’s efforts, visit the AADA’s dermatologic drug shortages page.

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