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Prescriptions Q&A
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Prescriptions Q&A
Question: May a pharmacist fill a controlled substance prescription, if the
prescribing practitioner is not registered with DEA in the same state that
the pharmacy is located?
Answer: Neither the Controlled Substances Act nor DEA regulations prohibit
a pharmacist from filling a controlled substance prescription issued by a
practitioner who is registered with DEA in a state other than the state in
which the pharmacy is located. However, state laws may impact the
dispensing of out-of-state prescriptions and as such, pharmacies may wish
to consult with their state's pharmacy board. Pharmacists are reminded
that to be effective, a prescription for a controlled substance must be
issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice. 21 CFR 1306.04(a). The practitioner
is responsible for the proper prescribing and dispensing of controlled
substances, but a corresponding responsibility rests with the pharmacist
who fills the prescription. 21 CFR 1306.04(a). Pharmacists are encouraged
to review Appendix D, "Pharmacist's Guide to Prescription Fraud and
Identifying Out of Scope Prescriptions," in the DEA Pharmacist's
Manual. EO-DEA180, DEA-DC-85, June 20, 2024.
Question: Must practitioners who receive controlled medications from a
pharmacy, in accordance with 21 U.S.C. 829a(a), be registered with DEA at
every location at which they receive such controlled medications?
Answer: Yes. One of the conditions imposed by the statute authorizing the
delivery of opioids for maintenance or detoxification treatment of an
opioid use disorder is that the controlled medication be delivered to the
location that is listed on the practitioner's certificate of
registration. 21 U.S.C. 829a(a)(1). Thus, unless the practitioner is
registered at a particular location, there is no authorization for delivery
of the controlled medication to that location. Moreover, the CSA requires a
separate registration "at each principal place of business or professional
practice where the [registrant] . . . dispenses controlled substances." 21
U.S.C. 822(e)(1); see also 21 CFR 1301.12(a). The term "dispense," as
defined in 21 U.S.C. 802(10), means to "deliver a controlled substance to
an ultimate user or research subject by, or pursuant to the lawful order
of, a practitioner, including the prescribing and administering of a
controlled substance." EO-DEA285, DEA-DC82, February 21, 2024
Question: When can a qualified practitioner start prescribing buprenorphine
for opioid use disorder (OUD) without a DATA-2000 waiver?
Answer: Qualified practitioners may now prescribe buprenorphine for opioid
use disorder (OUD) without a DATA-2000 waiver, as a result of legislation
recently passed by Congress. On December 29, 2022, President Biden signed
into law the CAA, 2023,[1] which in part included provisions to expand
patient access to medications for OUD. Specifically, the CAA, 2023 amended
the CSA to eliminate the "DATA-Waiver requirement," which had been codified
in 21 U.S.C. 823.
Prior to the CAA, 2023, DATA-waived practitioners were allowed to
administer, dispense, and prescribe any schedule III, IV, or V narcotic
drug approved by the Food and Drug Administration (FDA) specifically for
use in maintenance or detoxification treatment to a person with an opioid
use disorder (OUD) if the practitioner complied with the requirements found
under 21 CFR 1301.28. This regulation detailed an exemption for
practitioners from registration as a narcotic treatment program, or opioid
treatment program, if the practitioner submitted notification to the
Secretary of Health and Human Services (HHS) stating their intent to
dispense or prescribe FDA-approved narcotic drugs, or opioid medications,
for the treatment of OUD. Section 1262 of the CAA, 2023 removed the federal
requirement for a practitioner to submit notification to the Secretary of
HHS, and removed the other limitations previously applicable to DATA-waived
practitioners.[2] As of December 29, 2022, there is now no requirement that
only DATA-waived practitioners can administer, dispense, or prescribe
FDA-approved narcotic drugs, or opioid medications, for the treatment of
OUD. DEA is in the process of amending its regulations and revising its
guidance documents to reflect these statutory changes.
Section 1263(a) of the CAA, 2023 also amended the CSA by adding subsection
(l) to 21 U.S.C. 823, which requires training for prescribers.
Specifically, the new 21 U.S.C. 823(l)(1) provides that, "[a]s a condition
on registration under this section to dispense controlled substances in
schedule II, III, IV, or V, the Attorney General shall require any
qualified practitioner, beginning with the first applicable registration
for the practitioner to meet" certain conditions; the specific conditions
are divided into a list if the practitioner is a physician and another list
if the practitioner is not a physician. Section 1263(a) of the CAA, 2023
defines the term "qualified practitioner" as a practitioner who (i) is
licensed under State law to prescribe controlled substances, and (ii) is
not solely a veterinarian, under 21 U.S.C. 823(l)(4)(B). The term "first
applicable registration" means the first registration or renewal of
registration by a qualified practitioner on or after June 27, 2023, under
21 U.S.C. 823(l)(4)(A). Please see our DEA guidance portal for additional
information on the training requirement.
As of June 27, 2023, all practitioners are required to attest to completing
the CAA, 2023 training requirement when applying for an initial
registration or renewing their registration. All practitioners, who are not
solely a veterinarian, must satisfy the training, credentialing, or
educational requirements identified in section 1263 of the CAA, 2023 in
order to obtain a DEA registration. The deadline for attesting to this
training requirement is the date of a practitioner's next scheduled DEA
registration submission - regardless of whether it is an initial
registration or a renewal registration.
Therefore, any qualified practitioner can treat patients who screen
positive for OUD with buprenorphine. This includes prescribing,
administering, or dispensing buprenorphine with their DEA registration as
long as there are no state regulations that prohibit (or limit) them from
participating in this activity. DEA Registration numbers no longer indicate
DATA-waivers, and prescriptions for buprenorphine no longer require the
DATA-waivered or "x" waivered number on them, with the elimination of the
DATA-waivered requirement in the CAA, 2023.
Both the CSA and the DEA regulations continue to require that a
prescription for a controlled substance must be issued for a legitimate
medical purpose by a practitioner acting in the usual course of
professional practice. 21 CFR 1306.04(a).
Some pharmacies have been reluctant to fill prescriptions for buprenorphine
and some wholesalers have limited distribution based on perceptions or
fears that filling prescriptions or distributing buprenorphine may generate
an investigation. As noted above, the intent of the MAT Act was to expand
patient access to medications for OUD by eliminating regulations that
limited access to medications. Therefore, it is expected that this will
result in more prescribing of buprenorphine and dispensing of greater
amounts of buprenorphine than in previous years.
While the practitioner is responsible for the proper prescribing and
dispensing of controlled substances, a corresponding responsibility rests
with the pharmacist who fills the prescription. 21 CFR 1306.04(a). 21 CFR
1306.06.
Additionally, prescribers and pharmacists should check state laws or
contact their state pharmacy board for any limitations. EO-DEA261,
DEA-DC-078, November 28, 2023
Question: What changes can be made to a schedule II paper prescription?
Answer: In the past few months, DEA has received an increasing number of
questions concerning pharmacists' ability to add or modify
information-like a patient's address-on paper prescriptions. To
address these questions, DEA has been reviewing the relevant regulations
and working to draft new regulations to address this issue. In the interim,
pharmacists should adhere to state regulations or policy regarding those
changes that a pharmacist may make to a schedule II prescription after oral
consultation with the prescriber. EO-DEA257, DEA-DC-063, October 18, 2022
Question: Does the CSA or DEA regulations prohibit DEA-registered
practitioners or mid-level practitioners from issuing controlled substance
prescriptions for personal use of the prescriber, friends, or family
members?
Answer: No. However, practitioners and mid-level practitioners should be
aware when prescribing controlled substances for personal use of the
prescriber, friends, and family members, that the CSA and DEA regulations
require that a prescription for a controlled substance be issued for a
legitimate medical purpose by a practitioner acting in the usual course of
professional practice. The practitioner is responsible for the proper
prescribing and dispensing of controlled substances, but a corresponding
responsibility rests with the pharmacist who fills the prescription. An
order purporting to be a prescription that is not issued for a legitimate
medical purpose in the usual course of professional treatment or in
legitimate and authorized research is not a prescription within the meaning
and intent of 21 U.S.C. 829. The person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances. 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Further,
a prescription may not be issued in order for an individual practitioner to
obtain controlled substances for supplying the individual practitioner for
the purposes of general dispensing to patients. 21 CFR 1306.04(b). In
addition, prescribing practitioners and mid-level practitioners must comply
with applicable State, Federal, and local laws which may prohibit such
activity. 21 U.S.C. 823(f)(4). The contents of this document do not have
the force and effect of law and are not meant to bind the public in any
way. This document is intended only to provide clarity to the public
regarding existing requirements under the law or Department of Justice
policies. EO-DEA099, October 4, 2022
Question: Can I send electronic controlled substance prescriptions to a
pharmacy via e-mail?
Answer: No. "An electronic prescription"-that is, "a prescription that is
generated on an electronic application and transmitted as an electronic
data file"-must "be created and signed using an application that meets
the requirements of part 1311 of this chapter." 21 CFR 1300.03, 1306.05(e).
These requirements include, among other things, an audit or certification
to ensure that the application "records, stores, and transmits" the
necessary information "accurately and consistently," the capability to
"[l]ink each registrant, by name to at least one DEA registration number,"
logical access controls "set by individual user name or role" that limit
permissions for "signing controlled substance prescriptions," the ability
to "accept two-factor authentication," and digital signature functionality
that satisfies the relevant Federal Information Processing Standards (FIPS)
developed by the National Institute of Standards and Technology. 21 CFR
1300.03, 1311.120(b). E-mail does not satisfy these requirements.
EO-DEA094, DEA-DC-049, November 20, 2020
Question: May a prescription be issued in order for a practitioner to
obtain controlled substances for dispensing to patients?
Answer: No. See 21 CFR 1306.04(b), "A prescription may not be issued in
order for an individual practitioner to obtain controlled substances for
supplying the individual practitioner for the purpose of general dispensing
to patients." EO-DEA098, October 19, 2020
Question: I write controlled substance prescriptions to my patient. Does
Federal law require that I see the patient every 30 days?
Answer: No. Neither the CSA nor DEA regulations require a practitioner to
see a patient every 30 days. Nonetheless, the CSA and DEA regulations do
require that a prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice. See 21 CFR
1306.04(a). As DEA has previously stated, "practitioners who prescribe
controlled substances must see their patients in an appropriate time and
manner so as to meet their obligation to prescribe only for a legitimate
medical purpose in the usual course of professional practice and to thereby
minimize the likelihood that patients will abuse, or become addicted to,
the controlled substances." Issuance of Multiple Prescriptions for Schedule
II Controlled Substances, 72 FR 64921, 64928 (2007). EO-DEA093, June 23,
2020
Disclaimer: Guidance documents, like this document, are not binding and
lack the force and effect of law, unless expressly authorized by statute or
expressly incorporated into a contract, grant, or cooperative agreement.
Consistent with Executive Order 13891 and the Office of Management and
Budget implementing memoranda, the Department will not cite, use, or rely
on any guidance document that is not accessible through the Department's
guidance portal, or similar guidance portals for other Executive Branch
departments and agencies, except to establish historical facts. To the
extent any guidance document sets out voluntary standards (e.g.,
recommended practices), compliance with those standards is voluntary, and
noncompliance will not result in enforcement action. Guidance documents may
be rescinded or modified in the Department's complete discretion,
consistent with applicable laws.
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DIVERSION CONTROL DIVISION
U.S. Department of Justice
Drug Enforcement Administration
DIVERSION CONTROL DIVISION
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