Failure to comply with the Controlled Substances Act (CSA) and Drug Enforcement Agency (DEA) requirements can result in significant fines and penalties for pharmacies; thus, it is important that all pharmacies be aware of and implement new regulatory changes adopted by the DEA.
DEA Theft-Reporting Requirements
On June 22, 2023, the DEA published a final rule amending the regulations regarding DEA Form 106, used by DEA registrants to formally report thefts or significant losses of controlled substances, to require that all such forms be submitted electronically (paper copies of DEA Form 106 will no longer be accepted), and to clarify the time frame that registrants have to complete the necessary documentation.1Step 1: The Final Rule two-step DEA Form 106 reporting requirement requires registrants to first report a theft or significant loss in writing within 1 business day of discovery.2 The 1-day reporting notification is intended to notify the DEA right away about the theft and significant loss, to provide an immediate record of the initial incident, and to give the DEA the opportunity to promptly institute any actions deemed appropriate to the situation, including working with the registrant to address the theft or loss.
Step 2: The DEA acknowledges that adequate time is needed to complete an accurate and thorough investigation, and therefore, the DEA will allow registrants “45 calendar days” (for nonpractitioners) and “within 45 days” (for practitioners) after discovery (which the DEA believes is more than enough time to conduct investigations) to submit DEA Form 106 through the agency’s secure network application.3
Medical Group/Clinic Reporting Requirements: The DEA notes that individual registrants in a multiple-registrant medical group or clinic setting should be responsible for their own records and controlled substance storage. Records and controlled substances for each DEA registrant should be kept separate from those for all other registrants to aid in distinguishing which controlled substances belong to which DEA registrant. Therefore, each registered practitioner whose stock was affected by the theft or loss is responsible for providing the 1-day notification and for filing DEA Form 106.4
“Significant Loss” Definition: The DEA rule fails to clarify the definition of “significant loss,” as the DEA indicated that “significant” is a determination that each DEA registrant must make for themself. The distinction between a significant loss and a normal loss is case- and circumstance-specific, and registrants are best positioned to determine whether a loss rises to the level of a significant loss.5
“Discovery” Definition: The Final Rule fails to clarify the definition of “discovery”; however, the DEA acknowledged that there is confusion regarding the meaning of “discovery” and recognized that discovery occurs in incremental stages. The DEA indicated that it would address the issue of discovery in future regulations.6
Partial Refills for C-II Controlled Substances
The DEA recently issued a Final Rule to implement the Comprehensive Addiction and Recovery Act (CARA) of 2016, which amended section 21 U.S.C. 829 of the CSA by adding subsection (f) to allow a pharmacist to partially fill a prescription for a Schedule II controlled substance under certain conditions.7,8 Specifically, subsection 21 USC 829(f)(1) allows such partial filling where requested by the prescribing practitioner or the patient provided that all of the following conditions are satisfied: (1) The partial filling must not be prohibited by state law; (2) the prescription must be written and filled in accordance with the CSA, DEA regulations, and state law; and (3) the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed. In addition, subsection (f)(2) provides that the remaining portions of a partially filled prescription for a Schedule II controlled substance, if filled, must be filled no later than 30 days after the date on which the prescription is written, unless the prescription is issued as an emergency oral prescription, in which case the remaining portion, if filled, must be filled no later than 72 hours after it was issued.9General Requirements: Generally, the prescribing practitioner or a patient must request a partial fill for a prescription for a Schedule II controlled substance. Such a prescription may be partially filled if it is not prohibited by state law and it is written in accordance with the CSA, DEA regulations, and state law. Also, the total quantity dispensed in all of the partial fillings cannot exceed the total quantity prescribed by the practitioner.10
Time Limitations: After the first partial fill of the prescription for a Schedule II controlled substance is filled, if a patient chooses to fill the remainder, the remaining portions must be filled no later than 30 days after the date of the prescription. However, when it is an emergency oral prescription, the remainder, if filled, must be filled no later than 72 hours after the date of the prescription.11
Request of C-II Partial Fill by a Practitioner: The practitioner is required to specify the quantity to be dispensed in the partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription. This information must be included on the prescription, along with other information required for issuing a prescription, at the time it is signed by the practitioner.
A practitioner may request a partial fill or refill at a later date than when issuing the original prescription, as a partial fill may be requested directly by the prescribing practitioner, or it may be authorized by the prescribing practitioner during subsequent communication between the pharmacist and practitioner following the date after the prescription was first issued.12 The pharmacist must add the partial-fill request to the prescription for a Schedule II controlled substance by notating on the prescription “Authorized by Practitioner to Partial Fill.” The annotation must also include the name of the practitioner the pharmacist spoke with, the date and time of the communication, and the pharmacist’s initials.13
Request of C-II Partial Fill by a Patient or Patient Caregiver: A patient may request the partial filling of a prescription for a Schedule II controlled substance at the pharmacy, even if the prescribing practitioner did not specify a request for a partial filling.14 The patient may request the partial filling utilizing alternative pathways for the patient to make such a request and specify the amount to be filled (e.g., phone call by the patient to the pharmacist or a signed written note from the patient and delivered by a family member to the pharmacist).15 A patient caregiver may request a partial filling when the patient is a minor child (aged young than 18 years) or an adult who has named his or her caregiver as his or her agent in the adult patient’s medical power of attorney.16 On all such partial fill requests and filling, the pharmacist must record: (1) “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney, whichever is applicable] requested partial fill on [date such request was made],” and (2) the quantity dispensed.17
Pharmacy Recording of Partial Fills: The various types of prescriptions (written prescriptions, emergency oral prescriptions, or electronic prescriptions) may require varying methods for annotation of the partial fill option to prevent over-dispensing of controlled substances. When presented with a prescription properly specifying a partial fill request, the pharmacist must record the partial filling in a manner similar to that required under the existing regulations for other circumstances.18 Specifically, upon each such partial fill request, the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription or in the pharmacy’s electronic recordkeeping system, in the written record or in the pharmacy’s electronic recordkeeping system of the emergency oral prescription, or in the record of the electronic prescription.19 In addition, for electronic prescriptions, there must be an electronic prescription record, and the record must be permanently attached to the electronic prescription.20 Lastly, for each such partial filling, the pharmacy must maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required for Schedule III and IV prescription refills.21
Transfer of Electronc Prescriptions for Schedules II–V Controlled Substances Between Pharmacies for Initial Filling
This final rule, effective August 28, 2023, amends DEA regulations to allow the transfer of electronic prescriptions for Schedules II–V controlled substances between registered retail pharmacies for initial filling, upon request from the patient, on a one-time basis.22Prescription Transfer Authorization: The DEA amended regulations allow, upon request from the patient, the transfer of electronic prescribing of controlled substances (EPCS) prescriptions between registered retail pharmacies for initial filling on a one-time basis only. The DEA regulations permit an electronic prescription for a controlled substance in Schedule II–V to be transferred between retail pharmacies for initial filling on a one-time basis only upon request from the patient, and it clarifies that any authorized refills included on a prescription for a Schedule III, IV, or V controlled substance are transferred with the original prescription.23
Prescription Transfer Requirements: The final rule specifies that the prescription must be transferred in its electronic form and may not be converted to another form (e.g., paper, facsimile) for transmission. The information required to be on a controlled substance prescription pursuant to 21 CFR part 1306 must be unaltered during the transmission. The transfer must be communicated between two licensed pharmacists, and the transfer of EPCS for initial dispensing is permissible only if allowable under existing state or other applicable law.24
Prescription Transfer Documentation Requirements: A pharmacist transferring an electronic controlled substance prescription must update the electronic prescription record to note that the prescription was transferred. The transferring pharmacist must also update the prescription record with the following information: the name, address, and DEA registration number of the pharmacy to which the prescription was transferred; the name of the pharmacist receiving the transfer; the name of the transferring pharmacist; and the date of the transfer. Similarly, the pharmacist receiving the transferred prescription must record the transferring pharmacy’s name, address, and DEA registration number, the name of the transferring pharmacist, the date of the transfer, and the name of the pharmacist receiving the transfer. In lieu of manual data entry, the transferring or receiving pharmacy’s prescription processing software may, if capable, capture the aforementioned required information from the electronic prescription and automatically populate the corresponding data fields to document the transfer.25
Recordkeeping Requirements: Electronic records documenting EPCS transfers are to be maintained for a period of 2 years from the date of the transfer by both the pharmacy transferring the prescription and the pharmacy receiving and filling the prescription.26
DEA Extends COVID-19 Controlled Substances Telemedicine Rules for 6 Months While Considering Comments From the Public
On May 9, 2023, the DEA issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”—a temporary rule (the “Rule”) that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE).27 The telemedicine flexibilities adopted during the PHE relate to:• DEA Multiple State Registration Requirements for Practitioners
• In-Person Patient Evaluation Requirement
• Buprenorphine Prescribing Requirements.
The DEA received over 38,000 comments on its proposed telemedicine rules, and the DEA is now actively reviewing the comments and hosting listening sessions with practitioners to incorporate such input in the DEA’s development of a permanent Controlled Substances telemedicine rule.28,29
The Rule adds new 21 CFR 1307.41 and 42 CFR 12.1, effective from May 12, 2023, through November 11, 2024.30 The Rule extended the COVID-19 telemedicine prescribing flexibilities for 6 months, from May 12, 2023, through November 11, 2023, provided all of the prescribing conditions listed below were met:
Legitimate Medical Purpose: The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
Telemedicine Communication: The prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system (audio and video equipment permitting two-way, real-time interactive communication) or, for prescriptions to treat a mental health disorder (which include prescriptions for buprenorphine for opioid use disorder), a two-way, real-time audio-only communication if the distant-site physician or practitioner is technically capable of using an interactive audio-video telecommunications system but the patient is not capable of, or does not consent to, the use of video technology.31
DEA Registration: The practitioner must be authorized under his or her registration to prescribe the basic class of controlled medications specified on the prescription or be exempt from obtaining a registration to dispense controlled medications.32,33
DEA Requirements: The prescription must be consistent with all other DEA requirements.34 The Rule further provides for an extension of those telehealth flexibilities through November 11, 2024, but only with respect to patients with whom the prescribing practitioner has issued the patient a prescription for controlled medications pursuant to the COVID-19 telemedicine flexibilities prior to November 11, 2023.35
Conclusion
The DEA and State Boards of Pharmacy are devoting significant resources to the regulations governing controlled substances prescribing and dispensing. A pharmacy’s failure to comply with the CSA and other DEA requirements may result in pharmacy board and/or DEA investigations, pharmacy board disciplinary actions, DEA enforcement actions, and criminal or civil charges.36Given this climate of heightened scrutiny, it is essential that pharmacies mitigate controlled substances compliance risks by monitoring and implementing new DEA requirements. Establishing a comprehensive controlled substance compliance program, including constantly developing and updating policies and procedures, establishing proper monitoring processes, and preparing for a DEA audit, will provide the best defense against a DEA audit or investigation.37
REFERENCES
1. Reporting Theft or Significant Loss of Controlled Substances 88 Fed. Reg. 40707 (June 22, 2023).2. Id.
3. Id.
4. Id.
5. Id.
6. Id.
7. Partial Filling of Prescriptions for Schedule II Controlled Substances, 88 Fed. Reg. 46,983 (July 21, 2023).
8. 21 USC 829(f).
9. Id.
10. 21 CFR 1306.13(b)(1).
11. 21 CFR 1301.13(b)(2).
12. 21 CFR 1306.13(b)(5)(i).
13. Id.
14. 21 CFR 1306.13(b)(4).
15. Id.
16. Id.
17. 21 CFR 1306.13(b)(5)(ii).
18. 21 CFR 1306.13(b)(5)(i).
19. Id.
20. Id.
21. Id.
22. Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling.
23. Id.
24. Id.
25. Id.
26. Id.
27. Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. 88 FR 30037.
28. Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. at 12881, 12890.
29. Id.
30. 42 CFR 410.78(a)(3).
31. 21 CFR 1301.13(e)(1)(iv).
32. 21 U.S.C. 822(d).
33. 21 CFR part 1306.
34. Id.
35. DEA Inspections and Audits Warrant Compliance Plan, Part 2. Compliance Today. December 2019.
36. DEA Inspections and Audits Warrant Compliance Plan, Part 1. Compliance Today. November 2019.
37. Id.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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