A final rule issued by the DEA July 27 allows an electronic prescription for a controlled substance (EPCS) in Schedule II-V to be transferred between registered retail pharmacies for initial filling on a one-time basis upon request by the patient. The rule takes effect Aug. 28 (88 Fed. Reg. 48365, July 27, 2023).

A notice of proposed rulemaking (NPRM) to allow electronic controlled substance prescription transfers was published in the Federal Register in November 2021 (86 Fed. Reg. 64881).

Requirements

The final rule provides that any authorized refills included on a prescription for a Schedule III, Schedule IV or Schedule V controlled substance are to be transferred with the original prescription.

Also under the final rule:

• the transfer must be communicated between two licensed pharmacists;
• the prescription must remain in electronic form; and
• the contents of the prescription required under 21 C.F.R. Part 1306 must remain unaltered during the transmission.

Moreover, the transfer of an EPCS for initial dispensing is allowed only if it is allowed under applicable state law or any other applicable laws.

The final rule also specifies the following:

Information to be recorded to document the transfer of the EPCS. The transferring pharmacist must add the following to the electronic prescription record:

• information that the prescription has been transferred;
• the name, address and DEA registration number of the pharmacy to which the prescription was transferred, as well as the name of the pharmacist receiving the prescription information; and
• the date of the transfer along with the name of the pharmacist transferring the prescription information.

The final rule also imposes duties on the pharmacist who receives the EPCS. The receiving pharmacist must:

• add the word “transfer” to the electronic prescription record at the receiving pharmacy;
• include in the prescription record the name, address and DEA registration number of the pharmacy from which the prescription was transferred, along with the name of the transferring pharmacist; and
• record the date of the transfer and the name of the receiving pharmacist.

Use of prescription processing software. Instead of by manual data entry, the information required to be added to the prescription record may be captured by either pharmacy’s prescription processing software, which may automatically populate the corresponding data fields to document the transfer of the EPCS between the pharmacies.

The transferring or receiving pharmacist, as applicable, must ensure that the populated information is complete and accurate.

Maintenance of electronic records. The electronic records documenting the transfer of the electronic prescription must be maintained by both the transferring pharmacy and the receiving pharmacy for two years from the date of the transfer.

Refills. A pharmacy may transfer electronic prescription information for a Schedule III, Schedule IV or Schedule V controlled substance to another pharmacy for purposes of refill dispensing in compliance with 21 C.F.R. §1306.25. No prescription for a controlled substance in Schedule II may be refilled (21 U.S.C. §829(a); 21 C.F.R. §1306.12(a)).

Cost Savings

In the preamble to the final rule, the DEA estimated the cost savings under the final rule at $29 million per year — an increase of $7 million over the estimated cost savings included in the NPRM.

The DEA promulgated the rule in part to alleviate the possible diversion of controlled substances when a pharmacy that receives an electronic prescription cannot fill it.

In such a case, the agency noted, if the patient is forced to contact his or her practitioner to request that a new prescription be sent to a different pharmacy, duplicate prescriptions could be filled if the first pharmacy does not cancel or void the original prescription. The scenario risks the possibility of the prescription being filled twice, the DEA said, as well as creating an additional burden for the patient.

“As more practitioners are issuing controlled substance prescriptions electronically,” the DEA said in the preamble to the final rule, “there is an increasing need to address how a pharmacy should handle an electronic controlled substance prescription that it receives but cannot fill.”

A DEA interim final rule issued in March 2010 (75 Fed. Reg. 16236) provided practitioners the option of issuing — and provided pharmacies the option of receiving, dispensing and archiving — EPCS for Schedule II-V controlled substances.

In August 2020, the Centers for Medicare and Medicaid Services reported that it had seen a steady increase in the volume of controlled substance prescriptions submitted electronically.

Since January 2021, electronic prescribing for most Schedule II-V controlled substances covered by Medicare Part D has been mandated under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).

According to one study, the rate of electronic prescribing of controlled substances increased from 38 percent in 2019 to 58 percent in 2020 and to 73 percent in 2021.

The final rule amends 21 C.F.R. §1306.08 by adding five subparts to the regulatory section.