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USP update on access to buffered lidocaine

Nov. 30, 2018

The American Academy of Dermatology Association met with representatives from the United States Pharmacopeial Convention (USP), the FDA, and the CDC to discuss proposed revisions to Chapter 797 on compounded sterile preparations that, if finalized and adopted by state pharmacy boards, would create burdensome requirements for compounding sterile preparations.

The AADA — along with representatives from the American College of Mohs Surgery, the American Medical Association, the American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery — stressed the importance of access to buffered lidocaine for dermatology patients, and the need for physicians to prepare buffered lidocaine ahead of patient visits to facilitate access and avoid interruption of longer procedures such as Mohs surgery. Specifically, the groups requested USP to change the one-hour exemption to a 12-hour exemption.
Suzanne Olbricht, MD, Seemal R. Desai, MD, Allison Vidimos, RPh, MD, Jack Resneck Jr., MD, CDR Josephine Nguyen, MD, MHCDS, and Murad Alam, MD, attended the meeting. The organizations in attendance also signed on to the AADA’s comment letter on the issue.

The USP Compounding Expert Committee will meet to discuss the comments received by the AADA and other organizations and will finalize revisions to chapter 797. Stay tuned to Dermatology World Weekly for updates.

Issue breakdown: Compounding standard would disrupt care

Dermatologists welcomed news last month that the FDA may not enforce burdensome requirements of physicians engaging in common compounding practices such as buffering lidocaine in their offices. However, this might simply tip the issue to the states as new compounding standards are expected from The United States Pharmacopeial Convention (USP) that would suggest similarly burdensome requirements on physician offices.

What is USP and why does it matter?
USP is an independent non-profit group that develops health care quality standards. While they are not a regulatory agency and don’t have any enforcement authority, their standards are often adopted by those who do, including federal and state policymakers and accreditation bodies like the FDA, CMS, the CDC, the Joint Commission, and state pharmacy boards.

Updates to chapter 797 of USP’s compounding standards, which outline requirements for compounding sterile drugs in physician offices, have been or could be adopted at the state level across the country.

If you live in a state where the pharmacy board has or is considering adopting chapter 797 for physician offices, this proposal is particularly important.

What does 797 mean for dermatology?
The revised standards as currently proposed outline a number of requirements that would create burdens in dermatology offices engaged in common patient care activities. The new standards suggest requirements for compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations. These proposals would impact everyday activities like how you buffer lidocaine (with or without epinephrine) without sodium bicarbonate, dilute triamcinolone acetonide, and reconstitute botulinum toxins. For example, one proposal would require the administration of buffered lidocaine within one hour of preparation.

What is the AADA doing?
Although the USP is not a government group, they do work for transparency in their process. As such, they seek input from outside experts during the development of new standards and updates and obtain public comment from stakeholders before final publication

The American Academy of Dermatology Association’s Compounding Workgroup analyzed the draft revisions and will be providing detailed comment on its impact on care, particularly the need for access to compounded sterile preparations in dermatology.

What can I do?
While the AADA’s official response is critical, impacted dermatologists need to weigh in as well. The first version of these standards received 8,000 public comments, sending USP back to the drawing board. Hearing from you will ensure that the final standard reflects the best practice for dermatology patients.

Send your comment to USP with the AADA’s easy-to-use tool. Comments are due by Nov. 30.

AADA testified before Congress on compounding issues

January 30, 2017

Bruce A. Brod, MD, FAAD, Chair of the AADA's Congressional Policy Committee, today testified on office-use compounded medications and in-office preparations before the House Energy and Commerce Committee's Subcommittee on Health. Also among those testifying were Scott Gottlieb, MD, who serves as the commissioner of the Food and Drug Administration. Click here for more information on the hearing, to watch the hearing, and to read Dr. Brod's statement for the record.

 Dr. Brod at E&C on compounding issues Photo by the House Energy and Commerce Committee.

AADA sends regulatory relief recs to Medicare Red Tape Relief Project

August 25, 2017 

The American Academy of Dermatology Association (AADA) today sent a letter to the U.S. House Ways and Means Committee offering recommendations for the Committee’s Medicare Red Tape Relief Project ― an initiative that seeks to mitigate burdensome Medicare regulations. Among several recommendations, the AADA suggested the streamlining of drug prior-authorization requirements.

AADA supports bill to ensure access to compounded drugs

June 16, 2017

Congressman Morgan Griffith (R-VA) and Congressman Henry Cuellar (D-TX) have introduced legislation to address the unintended consequences of the Food and Drug Administration's (FDA) interpretation of the Drug Quality and Security Act and facilitate physician access to compounded drugs for administration in a clinical setting. The AADA has sent a letter of support for the legislation, titled the Preserving Patient Access to Compounded Medications Act (H.R. 2871).

Lawmakers push FDA to rescind guidance on compounding

May 24, 2017

Congressmen Buddy Carter (R-GA) and Chris Stewart (R-UT) spearheaded a letter to Food and Drug Administration Commissioner Scott Gottlieb urging the agency to rescind Guidance for Industry issued in December 2016 that restricts physician and patient access to compounded drugs for office-use. This letter, which was signed by 65 members of the House of Representatives, was supported by the AADA and the Drug Quality and Security Act (DQSA) Coalition.

Academy submits input to FDA on compounding

July 19, 2016
The Academy submitted input to the Food and Drug Administration (FDA) in response to its draft guidance on:

FDA releases final guidance on compounding using bulk drug substances

June 9 , 2016
The FDA released its final guidance titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The AADA asked the FDA to finalize its proposal to not take enforcement action against bulk substances, such as canatharidin, that FDA had approved for inclusion on the bulk substance list but additions had not been finalized through notice-and-comment rulemaking in the Federal Register. Read the AADA's comment letter.

In the final guidance, the FDA stated that it understood that the administrative process could be causing “unnecessary and inappropriate disruptions in patient care” and finalized its non-enforcement policy where the bulk drug substance nomination included adequate information for FDA evaluation and the substance does not appear to present significant safety risks. 

AADA testifies on in-office compounding

June 3, 2016
On Friday, June 3, Dr. Bruce Brod, chair of the Congressional Policy Committee, presented testimony at the FDA on compounding. Read Dr. Brod's testimony.