The U.S. Pharmacopeial Convention (USP) is currently revising its standards in its General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. These standards are considered for adoption by incorporation by state pharmacy boards, CMS, CDC, and The Joint Commission. Your state may have already adopted the current version of this chapter or its adoption in the future. If a state adopts these standards in a manner that makes the chapter applicable to physicians, it will affect dermatologists’ ability to prepare sterile medications in the clinical setting, especially buffered lidocaine (lidocaine with or without epinephrine mixed with sodium bicarbonate).
USP proposed a one-hour exemption from the chapter’s equipment and process standards starting with preparation and administration. This does not accommodate practices that currently buffer lidocaine or other compounded sterile preparations more than one hour ahead of patient administration, though it is an improvement over the current, enforceable version that does not have this type of exemption. The equipment and process standards that dermatologists would need to comply with if outside of this proposed one-hour exemption are unreasonably burdensome, which include performing manipulations inside a certified ISO 5 area, conducting routine environmental monitoring, and conducting personnel sampling (including glove fingertip sampling).
The AADA will also be providing the opportunity for state dermatology societies to sign onto a letter in response to the USP’s proposed revisions to this chapter. The letter will be provided to your state society leadership for consideration on Monday, November 26. The deadline to sign-on is 5 pm ET on Thursday, November 29; comment letters to USP are due on November 30.
- Please share this with your members and encourage them to write the USP and request at least a 12-hour exemption from the chapter’s requirements. Dermatologists can access a template letter to write USP by the November 30 deadline in the AADA’s Advocacy Action Center (https://takeaction.aad.org/composeletters.aspx?AlertID=1710).
- If your state dermatology society would like to write its own letter to USP, the proposed revisions can be found here: http://www.usp.org/compounding/797-download. You can submit line-specific comments using this form: https://usp.az1.qualtrics.com/jfe/form/SV_3dDhnN2ZVCYh5yJ. Your state dermatology society can also submit a letter to the following e-mail address:CompoundingSL@usp.org.
Please consider incorporating the following talking points:
Talking Points:
- In-office compounded sterile preparations are important to the practice of dermatology. An in-office preparation especially important is buffered lidocaine. Sodium bicarbonate is added to lidocaine with epinephrine using aseptic technique to neutralize the pH of the preparation in a process called “buffering” to significantly decrease the pain of the injection and increase the onset of the local anesthesia. After this local anesthetic takes effect, dermatologists then perform procedures such as biopsies, excisions, or Mohs micrographic surgery.
- Many dermatology practices buffer lidocaine ahead of patient visits at the start of the day given the frequent use of this low-risk preparation in dermatology and that it is unnecessary to step away from patients to buffer lidocaine when it can be prepared ahead of time. This is an accepted standard of care that facilitates patient access and has continued without adverse incidents.
- Dermatologists are preparing buffered lidocaine for administration to their own patients in the clinical setting. Peer-reviewed scientific and medical journal articles support the safety, effectiveness, and stability of buffered lidocaine. Continuity of care is vital, which is why dermatologists and their clinical staff follow-up with the patient after the dermatologic procedure is performed to check on the patient and answer any patient questions.
- We are requesting at least a 12-hour exemption for these low risk and low volume in-office compounded sterile preparations to facilitate patient access. Patients should not have to wait for their physicians and the clinical staff to compound these preparations, especially during busy clinic days and especially not to interrupt longer procedures such as Mohs surgery. The one-hour exemption proposed is not nearly long enough to accommodate patients and not keep them waiting while medications are prepared. Extending the exemption to at least 12 hours allows more patients to be treated, which improves patient access.
In addition, the AADA will be meeting with representatives of the USP as well as the FDA and Centers for Disease Control and Prevention to discuss the need for patient access to buffered lidocaine in the context of this chapter. The AADA requested this meeting together with the ACMS, AMA, ASDSA, and ASMS.
If you have any questions, please contact Natasha Pattanshetti, JD, MPH, AADA’s manager of regulatory policy at npattanshetti@aad.org or (202) 712-2618.