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Buprenorphine (MOUD) Q&A
Home
Resources
Questions & Answers
Buprenorphine (MOUD) Q&A
Question: May a pharmacy deliver a prescribed buprenorphine product to a
practitioner for direct administration to the patient?
Answer: Yes, but only in limited circumstances involving injected or
implanted buprenorphine products. Buprenorphine is classified as a
"controlled substance" under the Controlled Substances Act (CSA) and is
an active ingredient in certain FDA-approved drug products or medications.
Delivery by a pharmacy of prescribed buprenorphine products to a
practitioner is not authorized for buprenorphine sublingual tablets, or for
other buprenorphine products that are not administered through injection or
implantation. Ordinarily, a prescription only authorizes a pharmacist to
dispense a controlled substance to an ultimate user, which includes a
patient or a member of the patient's household. 21 U.S.C. 802(10) and
(27); 21 CFR 1300.01 ("[p]rescription means an order for medication which
is dispensed to or for an ultimate user"). However, the Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act (SUPPORT Act) permits a pharmacy to deliver a
controlled substance prescribed for maintenance or detoxification treatment
to a practitioner's registered location for the purpose of direct
administration through either injection or implantation for maintenance or
detoxification purposes. 21 U.S.C. 829a(a).
The prescription must meet the requirements of the CSA and DEA regulations,
including the regulatory requirement that it may not be used to supply the
practitioner with stock for general dispensing to patients. 21 CFR
1306.04(b). The pharmacy may deliver the controlled substance to the
registered location of either the prescribing practitioner or the
administering practitioner, and the controlled substance must be
administered by injection or implantation only to the patient named on the
prescription no later than 45 days after the date of receipt of the
controlled substance by the practitioner. 21 U.S.C. 829a(a)(2) and
829a(a)(5).
Notwithstanding any exceptions under 21 U.S.C. 827, the prescribing
practitioner, and the practitioner administering the controlled substance,
as applicable, must maintain complete and accurate records of all
controlled substances delivered, received, administered, or otherwise
disposed of under 21 U.S.C. 829a, including the persons to whom controlled
were delivered. 21 U.S.C. 829a(a)(6). The pharmacy must maintain, for a
period of at least two years, complete and accurate records of all
controlled substances received, distributed, dispensed, or otherwise
disposed of, including either, where applicable, the original paper
prescription or an electronic prescription, which is readily retrievable.
See 21 CFR part 1304. The pharmacy must also comply with all other Federal
laws (including the Federal Food, Drug, and Cosmetic Act), as well as State
and local laws in the jurisdiction in which they are licensed. See, e.g.,
21 U.S.C. 355-1 and 21 U.S.C. 829a(a)(3). EO-DEA220R1, June 2024,
DEA-DC-045R1.
Question: I am an individual practitioner, or medical, surgical or other
specialty resident, who is an agent or employee of a hospital or other
institution, acting under the registration of the hospital or other
institution pursuant to 21 CFR 1301.22, and I am not separately registered
with DEA. Am I required to attest that I completed the 8-hour training
requirement in the CAA?
Answer: Individual practitioners, or medical, surgical, or other specialty
residents operating under the DEA registration of a hospital/clinic
pursuant to 21 CFR 1301.22(c) are not required to apply for or maintain a
DEA registration on an individual basis. Accordingly, individual
practitioners operating under the DEA registration of a hospital/clinic do
not have to attest to completing the CAA training, unless they are
separately registered. The new training requirement in section 1263(a) of
Division FF of the CAA went into effect on June 27, 2023, and applies to
all qualified practitioners "as a condition of registration . . . beginning
with the first applicable registration for the practitioner." 21 U.S.C.
823(l)(1). "First applicable registration" is defined as "the first
registration or renewal of registration by a qualified practitioner . . .
that occurs on or after [June 27, 2023]." 21 U.S.C. 823(l)(4).
DEA-registered hospitals may consider providing opportunities for
accredited training to residents and other practitioners who may be
treating patients and prescribing medications for SUD while operating under
the hospital's DEA registration. Section 1263 of the CAA allows for SUD
training to count towards meeting the DEA training requirement if it
occurred as part of medical school, nursing school, physician assistant
school, or dental school within 5 years of an initial DEA registration
application. Residency programs are part of training through accredited
medical, nursing, physician assistant, or dental schools, and training
provided by hospitals would meet the CAA training requirement.
For further background information please see the corresponding document
that is in the DEA Guidance Document Portal. EO-DEA274, DEA-DC-80, February
14, 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: In light of the elimination of the DATA-Waiver identifier (i.e.,
X-waiver number) from my DEA registration certificate, am I still able to
use my existing DEA-Form 222s to order controlled substances or should I
return them to DEA?
Answer: Yes, you can still use the existing forms. They DO NOT need to be
returned to DEA. On December 29, 2022, with the signing of the CAA of 2023,
Congress eliminated the DATA-Waiver requirement. Section 1262 of the CAA of
2023 removed the federal requirement for practitioners to apply for a
special waiver prior to prescribing buprenorphine for the treatment of
Opioid Use Disorder (OUD). It also removed the requirement for the
assignment of an identification number (i.e., X-waiver number) associated
with being a DATA-waived provider, for inclusion with the registration
issued to the practitioner. 21 U.S.C. 823(g)(2)(D)(ii). DEA-registered
practitioners, allowed to handle schedule I and II controlled substances,
are issued DEA-Form 222s. These forms are printed by DEA with the
practitioner's DEA registration number and registered location; however, no
forms were printed with a practitioner"s X-waiver number. As the X-waiver
numbers were not used previously to order controlled substances on DEA-Form
222s, no change is necessary. Orders for controlled substances are still
placed using your DEA number only. DEA-registered practitioners who are
allowed to handle schedule I and II controlled substances, may obtain and
use DEA-Form 222s. 21 CFR 1305.04(a). EO-DEA265, DEA-DC-069, April 2, 2023
Question: In light of the elimination of the DATA-Waiver (X-waiver)
requirement, do I need to take any action to get an updated DEA
registration certificate?
Answer: No action is needed on the part of registrants, as a result of the
statutory repeal of 21 U.S.C. 823(h)(2). On December 29, 2022, with the
signing of the CAA[i], Congress eliminated the DATA-Waiver requirement.
Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, §
1262(a)(1), 136 Stat. 4459, 5681 (2022) removed the federal requirement for
practitioners to apply for a special waiver prior to prescribing
buprenorphine for the treatment of Opioid Use Disorder (OUD). It also
removed the requirement for the assignment of an identification number
(i.e., X-waiver number) associated with being a DATA-waived provider, for
inclusion with the registration issued to the practitioner. 21 U.S.C.
823(h)(2)(D)(ii). EO-DEA260, DEA-DC-067, March 22, 2023
Question: Are there any limitations on the number of patients with OUD that
a practitioner may treat with buprenorphine after the passage of the
Consolidated Appropriations Act of 2023 (CAA)?
Answer: After enactment of the CAA,[i] there are no longer limitations,
under federal law, on the number of patients with OUD that a practitioner
may treat with buprenorphine. On December 29, 2022, President Biden signed
into law the CAA which expanded patient access to medications for OUD.
Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, §
1262(a)(1), 136 Stat. 4459, 5681 (2022) amended the Controlled Substances
Act by repealing the "DATA-Waiver" requirement codified in 21 U.S.C.
823(g)(2), which had previously imposed limits or patient caps on the
number of OUD patients a prescriber may treat with buprenorphine. These
limits were previously outlined at 21 U.S.C. 823(g)(2)(B)(iii), and allowed
qualified practitioners to treat up to 30, 100, or 275 patients at one
time. EO-DEA263, DEA-DC-066, March 21, 2023
Question: May a pharmacy deliver a prescribed buprenorphine product to a
practitioner for direct administration to the patient?
Answer: Yes, but only in limited circumstances. Ordinarily, a prescription
only authorizes a pharmacist to dispense a controlled substance to an
ultimate user, which includes a patient or a member of the patient's
household. 21 U.S.C. 802(10) and (27); 21 CFR 1300.01 ("[p]rescription
means an order for medication which is dispensed to or for an ultimate
user"). However, the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act)
permits a pharmacy to deliver a controlled substance prescribed for
maintenance or detoxification treatment to a practitioner's registered
location for the purpose of direct administration through either injection
or implantation to a narcotic dependent person. 21 U.S.C. 829a(a).
The prescription must be issued by a qualifying practitioner who is
authorized to prescribe controlled substances for maintenance or
detoxification purposes under 21 U.S.C. 823(g)(2) and the prescription must
meet the requirements of the Controlled Substances Act and DEA regulations,
including the requirement that it may not be used to supply the
practitioner with stock for general dispensing to patients. The pharmacy
may deliver the controlled substance to the registered location of either
the prescribing practitioner or the administering practitioner, and must be
administered by injection or implantation only to the patient named on the
prescription within 14 days after the date of receipt of the controlled
substance by the practitioner. 21 U.S.C. 829a(a)(2)(B) and 829a(a)(5).
Notwithstanding any exceptions under 21 U.S.C. 827, a practitioner
administering controlled substances must maintain complete and accurate
records of all controlled substances delivered, received, administered, or
otherwise disposed of under 21 U.S.C. 829a, including the persons to whom
controlled substances were delivered. 21 U.S.C. 829a(a)(6). The pharmacy
must maintain, for a period of at least two years, complete and accurate
records of all controlled substances received, distributed, dispensed, or
otherwise disposed of, including either, where applicable, the original
paper prescription or an electronic prescription which is readily
retrievable. See 21 CFR part 1304. The pharmacy must also comply with all
other Federal, State, local and tribal laws in the jurisdiction in which
they are licensed. See, e.g., 21 U.S.C. 829a(a)(3). Relatedly, nothing in
this guidance document relieves any pharmacy or other entity that dispenses
a buprenorphine product from any obligations that might arise under the
Federal Food, Drug, and Cosmetic Act, such as those relating to an
FDA-approved Risk Evaluation and Mitigation Strategy (REMS). EO-DEA220,
September 18, 2020, DEA-DC-045
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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