The Department of Justice recently published its list of proposed regulatory actions for the near and long term. It appears that the Drug Enforcement Administration’s (DEA’s) Regulatory Drafting and Support Section is going to have a busy year. The Unified Agenda indicates several potential regulatory changes are in store for the coming year, some of which may have significant impact on the regulated community.

A few highlights:

  • Updates to the suspicious order regulation have been delayed to at least February 2019.
  • DEA will provide guidance for Emergency Medical Services wishing to handle controlled substances.
  • After more than nine years, DEA is finally implementing regulations regarding the practice of telemedicine, as required by Congress in the Ryan Haight Act.
  • Guidance is forthcoming regarding the partial filling of prescriptions for Schedule II controlled substances as a result of related provisions in the Comprehensive Addiction and Recovery Act (CARA) of 2016.
  • It appears that additional (and significant changes) will be coming to DEA’s quota process.
  • DEA is getting rid of the carbon copy 222 form! (for those too young to understand the concept of carbon copies, click here)

Below are links to each notification and a summary taken directly from the related Abstract.

Revision of Hearing Procedures in Association With Show Cause Orders

The DEA proposes to amend its regulations to clarify the DEA’s obligation to ensure proper service of orders to show cause issued in connection with its administrative enforcement proceedings, and to conform its regulations with other Federal agencies that authorize a default finding where no response to the order to show cause is received notwithstanding legally sufficient service.

Emergency Medical Services (EMS)

The DEA is proposing to modify the regulations related to the registration requirements of DEA registrants to allow emergency medical services (EMS) registrants to transport controlled substances for the purpose of dispensing under certain circumstances, and provide the EMS community with specific requirements for EMS programs handling controlled substances. As a result of these modifications, the DEA would also modify the security, ordering, and recordkeeping requirements for those registrants who wish to transport controlled substances for the purpose of dispensing.

Special Registration to Engage in the Practice of Telemedicine

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) (Pub. L. 110-425) was enacted on October 15, 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the Internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the ‘‘practice of telemedicine’’ includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the Act’s in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the Act’s definition of the ‘‘practice of telemedicine’’ includes ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E). The Act also specifies certain criteria that DEA must consider when evaluating an application for such a registration. However, the Act contemplates that DEA must issue regulations to effectuate this special registration provision. The DEA proposes to amend the registration requirements to permit such a special registration

Registration Requirements for Mobile Narcotic Treatment Programs

The DEA is proposing to modify the regulations related to the registration requirements of DEA registrants relating to Mobile NTP’s. As a result of these modifications, the DEA would also modify the registration, security, ordering, and recordkeeping requirements for those registrants who wish to transport controlled substances for the purpose of dispensing for narcotic treatment.

New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)

The DEA is proposing to amend its regulations to implement a new format for order forms (DEA Form 222) which are issued by DEA to allow registrants to order schedule I and II controlled substances. The new forms will replace the current triplicate carbon-copy forms utilized by the DEA.

Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Partial Filling of Prescriptions for Schedule II Controlled Substances

On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) of 2016 became law. One section of the CARA amended the Controlled Substances Act to allow a pharmacist, if certain conditions are met, to partially fill a prescription for a schedule II controlled substance when requested by the prescribing practitioner or the patient. The Drug Enforcement Administration is proposing to amend its regulations to implement this statutory change.

Establishing Reporting Procedures for Purchasers and Suppliers to Follow in the Conduct of Double-Blind Studies

The Drug Enforcement Administration is proposing to update its regulations to establish a procedure for the use of the DEA Form 222 (DEA Official Order Form) in double-blind studies utilizing Schedule I or Schedule II controlled substances

Suspicious Orders of Controlled Substances

The Drug Enforcement Administration is proposing to revise its regulations relating to suspicious orders of controlled substances. The proposed rule defines the term suspicious order and specifies the procedures a registrant must follow upon receiving such orders.

Controlled Substances Manufacturing Quotas: Inventory Allowance; Subcategories for Quotas; Certification of Procurement Quota for Controlled Substances

The Drug Enforcement Administration proposes to revise and amend existing regulations to reduce overall inventories held by DEA-registered manufacturers and other registrants; to create use-specific subcategories for procurement quotas; and to clarify the current language and ensure that both manufacturers and distributors are required to obtain certification of a buyer’s quota for the requested schedules I and II controlled substances, as well as list I chemicals. These changes are necessary, in light of the increasingly complex controlled substances manufacturing business practices, to reduce the potential for the diversion of certain controlled substances. Due to this evolution of complexity in the pharmaceutical industry and the inflexible nature of the regulations by which DEA must calculate inventory allowances for manufacturers of controlled substances, the current inventory allowances provide opportunity for the accumulation of controlled substance surpluses to occur. These proposed regulations will rectify a situation where DEA’s ability to strike an appropriate balance between ensuring the availability of controlled substances to industry and the risk to public health and safety has been hindered and resulted in an overproduction of controlled substances inventories available for diversion.