DEA Compliance Highlights for 2022

By Dennis Wichern, Partner, Prescription Drug Consulting LLC

February 24, 2022

This year marks the 50th anniversary for DEA’s controlled substance regulations, many of which have stayed unchanged over the years, while a few have changed during the last several years due to Congressional lawmaking and DEA rulemaking. No matter the regulation change or “tweak”, DEA’s core regulations – drug recordkeeping and security - have and will continue to remain the agency’s primary focus. Here are the DEA compliance highlights for 2022.

Registration

The total number of DEA registrants continues to increase annually by a rate of approximately 50,000 per year. During 2020 DEA recorded over 1.86 million registrants which grew to 1.96 million during 2022.

Depending on your registration, generally a one year or three year period based on business activity, little has changed aside from the 2020 fee increases. DEA did change their renewal notification process as renewal notifications will no longer be sent though the US Postal Service. Instead, electronic reminders to renew a license will be sent at 60, 45, 30, 15, and 5 days prior to the expiration date of the registration to the associated email address.

Notably, DEA will continue to allow a grace period beyond the expiration date if the renewal application has been submitted prior to the registration’s expiration date.

Drug Recordkeeping & Inventories

DEA’s drug recordkeeping requirements remain the core of the agency’s authority and the only significant change occurred on October 30, 2021, when the DEA implemented the mandatory use of a single sheet DEA 222 as opposed to the old triplicate form. Power of Attorneys, biennial drug inventories, receiving, transferring, distributing and dispensing records, and the separation of Schedule II drugs and records have all remained the same.

On November 11, 2021, DEA issued an electronic reminder message to all registrants regarding prescriptions which stated, “that paper prescriptions, including prescriptions created on paper and prescriptions generated by computer or a prescription application that are printed out or faxed by a practitioner, must be manually signed by the prescribing practitioner.”

Drug Destruction and Theft/Loss

Drug destruction for registrants remains the same with the registrants having the option of destroying the drugs themselves with DEA approval, returning the drugs to the manufacturer/distributor or by transferring to a reverse distributor. DEA requires that all registrant destroyed drugs be “non-retrievable” meaning that, “for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.”

As far as drug thefts and significant losses DEA continues to require that these incidents be reported to DEA and local law enforcement within 24 hours via a DEA Form 106.

Drug Security

DEA’s drug security requirements have not had any substantial changes during the last 50 years. Depending on one’s business activity, self-closing doors, alarms, safes and security cameras are all standard DEA security requirements.

Suspicious Order Monitoring (SOM)

21CFR1301.74 (b) is commonly referred to as the SOM regulation which has remained unchanged for over 50 years but will likely change when DEA publishes its new promulgated regulations which could occur in 2022. DEA’s “Notice of Proposed Rulemaking” for this action was published in the Federal Register on November 11, 2020.

Recent SOM changes pursuant to the SUPPORT Act include the requirement that all DEA registrants that distribute controlled substances report suspicious orders to DEA at the online “Suspicious Orders Report System” (SORS). DEA has determined that an additional 15,974 registrants will now be required to identify and report suspicious orders. Previously, only manufacturers and distributors were required to report suspicious orders.

The “Catchall” Regulation

21CFR1301.71(a) which states, “all applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances” is commonly referred to as DEA’s “catchall” and overarching regulation. This regulation’s definition is highly subjective and dependent on a registrant’s business activity – a medical provider who only prescribes drugs would have little if any additional requirements for “effective controls and procedures” compared to a manufacturer or distributor who would be held to a much higher overall standard.

The majority of drug compliance professionals agree that in addition to DEA’s specific core recordkeeping and security requirements, most registrants should incorporate additional “controls and procedures” into to their overall drug compliance program to include written policies, employee training programs, hiring protocols, and the like, to prevent diversion.

Covid 19 Exceptions

When the Secretary of Health and Human Services declared the COVID-19 public health emergency on January 31, 2020, DEA subsequently granted a number of exceptions to its regulations relating to quotas, records and reports, registration, telemedicine, SOM, prescriptions, the National Drug Supply, electronic prescribing, medication assisted treatment and listed chemicals to assist in relief efforts.

It is anticipated that these exceptions will end when HHS no longer determines a public health emergency exists.

Wrap Up

DEA’s regulatory rules have remained relatively the same for over 50 years with its core regulations centering on drug recordkeeping and security; however, peripherally supporting regulations continue to change as a result of Congressional action and advancements in technology, which underscore the importance of maintaining a robust and up-to-date drug compliance program that includes periodic reviews.