DEA Issues Advanced Notice of Proposed Rulemaking, Solicits Feedback on Telepharmacy

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On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (ANPR) to seek public input from state regulatory authorities, national and professional associations, industry, telepharmacy vendors and servicers and the general public to better understand the practice of telepharmacy.1

Background

As entities that dispense controlled substances, telepharmacies fall under the jurisdiction of the Controlled Substances Act (CSA), which is enforced by the DEA. Under the CSA, the DEA is tasked with establishing and maintaining controls for the manufacturing, distribution, and dispensing of controlled substances. Entities that partake in certain activities involving controlled substances, including manufacturing, distribution, dispensing, importing, exporting or conducting research or chemical analysis, are required to register with DEA, unless an exemption applies. The CSA also authorizes the Administrator of DEA (due to a delegation of authority from the Attorney General) to register an applicant to manufacture, distribute or dispense controlled substances if the Administrator determines the registration would be consistent with the public interest.2 The Administrator may also promulgate regulations that are necessary and appropriate to execute certain functions of subchapter I of the CSA, involving controls and enforcement, and subchapter II, involving imports and exports.3 Pursuant to these provisions of the CSA, the DEA is considering promulgating regulations regarding telepharmacy.

The CSA does not include a definition for telepharmacy. According to the ANPR, DEA considers telepharmacy to be:

[T]he provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site. Such pharmacist care may include, but is not limited to: The dispensing and distribution of prescription drugs, drug use review, patient counseling services, and drug therapy monitoring. Depending on the relevant state authority and regulations, telepharmacies may fill paper prescriptions or electronic prescriptions.

The ANPR also states, “while the practice of telepharmacy varies from state to state, they generally fall within one of two categories: (i) Brick and mortar remote sites; and (ii) self-service, automated machines.” A brick and mortar remote site consists of traditional, storefront pharmacies, staffed with non-pharmacist employees who are remotely supervised by a pharmacist located in a separate “parent” or “hub” pharmacy, “via continuous and real-time computer, video, and audio links.” Self-service, automated machines consist of kiosks containing prescription medications, labeling equipment, and the telecommunication technology that can connect the patient to the remote pharmacist “via real-time video and audio links.” Automated machines may perform a number of functions, including accepting prescriptions, refilling orders, storing prepackaged or repackaged medications, labeling and dispensing prescriptions for a specific patient and dispensing the prescription to the patient-user.

The ANPR

Pursuant to the ANPR, DEA is soliciting comments from the public to be “fully informed about the practice, industry, and state regulation of telepharmacy.” These questions cover an array of topics broken down into specific categories geared towards different types of entities. Below is a brief summary of the questions posed by DEA in the ANPR.

The ANPR includes the following questions and requests to solicit input from state regulatory authorities:

  • Questions regarding current telepharmacy practices authorized in a state, current state licensing processes, the extent to which telepharmacies are operating in a state, and whether there are any state limits on the type or manner of prescriptions that can be filled by a remote site or automated machine.
  • Questions regarding the patient-practitioner relationship required prior to telepharmacy services for a controlled and/or non-controlled drug product and whether there are controlled substance volume limits or restrictions with telepharmacies.
  • Questions regarding the number of remote dispensing sites or automated machines one remote pharmacist can supervise at one time and the limits to how many remote pharmacists or organizations can access a dispensing site or automated machine.
  • Whether there are additional policies and procedures or security requirements that should be required of telepharmacies that are not required of other pharmacies.
  • Questions regarding certain restrictions on where or how a remote site or automated machine may be located or operated and whether the remote pharmacist needs to be in the same state as the remote sites or automated machines.
  • Whether the state allows for the interstate practice of telepharmacy and whether certain pharmacists with out-of-state licenses may serve as the pharmacist for a dispensing site or automated machine.
  • Questions regarding current recordkeeping, reporting and state inspection processes, and a request for examples of major issues associated with telepharmacy that have been reported to a state regulatory authority.
  • Questions regarding the employment of and required credentials for pharmacy technicians that staff remote sites.
  • Whether there are specific regulations or considerations regarding prescribing and dispensing opioid reversal agents.

The ANPR includes the following questions and requests to solicit input from industry/healthcare providers:

  • A question regarding whether remote sites or automated machines are typically owned and operated by the owner of the parent or hub pharmacy, and, if they do not share owners, how recordkeeping is handled.
  • Questions regarding how the pharmacist adequately supervises and oversees the telepharmacy technicians and staff and how the pharmacist makes his or her final verification of the filled prescription remotely.
  • Questions regarding the current barriers to adopting telepharmacy and what might be preventing full implementation of the use of electronic prescriptions.
  • Questions regarding how locations for remote sites or automated machines are selected.
  • Whether remote site or automated machines are registered with the DEA and, if so, under what business activity.
  • For remote pharmacists at a telepharmacy, a question regarding how many remote sites and automated machines the pharmacist can adequately supervise during the same period of time.

The ANPR includes the following questions and requests to solicit input from state telepharmacy vendors and servicers:

  • A question regarding how telepharmacy technology and systems safeguard against diversion by the public at large and by employees at remote sites and automated machines.
  • A question regarding how automated machines used in telepharmacy practice may differ or be similar to the Automatic Dispensing Systems used at Long Term Care Facilities from a design standpoint.
  • Questions regarding whether telepharmacy technologies and systems are compliant with the Health Insurance Portability and Accountability Act, accessible for individuals with disability, and offer 24/7 surveillance of the telepharmacy remote site or automated machine.

The DEA also included a request to all entities for information that can be used to help the agency quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy. Comments are due to the agency on or before January 18, 2022.

FOOTNOTES

  1. The ANPR is available at the following, Federal Register :: Regulation of Telepharmacy Practice.
  2. 21 U.S.C. § 823.
  3. 21 U.S.C. §§ 871(b), 958(f).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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