[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82267-82271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23495]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Halowells Pharmacy; Decision and Order

    On November 8, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Halowells Pharmacy (Registrant) of Pearland, 
Texas. Request for Final Agency Action (RFAA), Exhibit (RFAAX) A, at 1. 
The OSC/ISO informed Registrant of the immediate suspension of its DEA 
Certificate of Registration, Control No.

[[Page 82268]]

FH9037830, pursuant to 21 U.S.C. 824(d), alleging that Registrant's 
continued registration constitutes `` `an imminent danger to the public 
health or safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also 
proposed the revocation of Registrant's registration, alleging that 
Registrant's continued registration is inconsistent with the public 
interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
    The OSC/ISO notified Registrant of its right to file with DEA a 
written request for hearing, and that if it failed to file such a 
request, it would be deemed to have waived its right to a hearing and 
be in default. Id. at 9 (citing 21 CFR 1301.43). Here, Registrant did 
not request a hearing. RFAA, at 2.\1\ ``A default, unless excused, 
shall be deemed to constitute a waiver of the registrant's/applicant's 
right to a hearing and an admission of the factual allegations of the 
[OSC/ISO].'' 21 CFR 1301.43(e).
---------------------------------------------------------------------------

    \1\ Based on the Government's submissions in its RFAA dated 
January 4, 2024, the Agency finds that service of the OSC/ISO on 
Registrant was adequate and rendered on November 16, 2023. 
Specifically, the Government included as an attachment to its RFAA a 
Form DEA-12 signed by a representative of Registrant, indicating 
that Registrant was personally served with the OSC/ISO on November 
16, 2023. RFAA, at 1-2; RFAAX B.
---------------------------------------------------------------------------

    Further, ``[i]n the event that a registrant . . . is deemed to be 
in default . . . DEA may then file a request for final agency action 
with the Administrator, along with a record to support its request. In 
such circumstances, the Administrator may enter a default final order 
pursuant to [21 CFR] Sec.  1316.67.'' Id. Sec.  1301.43(f)(1). Here, 
the Government has requested final agency action based on Registrant's 
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 3; see 
also 21 CFR 1316.67.

I. Findings of Fact

    The Agency finds that, in light of Registrant's default, the 
factual allegations in the OSC/ISO are admitted.\2\ Registrant is 
deemed to have admitted that it repeatedly dispensed prescriptions in 
violation of the minimum practice standards that govern pharmacy 
practice in Texas. RFAAX A, at 4. Specifically, from at least January 
2022 through July 2023, Registrant repeatedly filled controlled 
substance prescriptions that contained multiple red flags of abuse and/
or diversion without addressing or resolving the red flags, in 
violation of both Federal and State law. Id. at 4-5.
---------------------------------------------------------------------------

    \2\ The Agency need not adjudicate the criminal violations 
alleged in the instant OSC/ISO. Ruan v. United States, 142 S. Ct. 
2,370 (2022) (decided in the context of criminal proceedings).
---------------------------------------------------------------------------

A. Pattern Prescribing

    Texas regulations identify the following prescribing patterns as 
red flag factors: Dispensing to numerous persons substantially 
identical prescriptions by the same prescriber for the same controlled 
substances; a prescriber's prescriptions are routinely for controlled 
substances commonly known to be abused drugs, including opioids; and a 
prescriber's prescriptions for controlled substances are commonly for 
the highest strength of the drug and/or for large quantities (e.g., 
monthly supply). 22 Tex. Admin. Code section 291.29(f)(1), (3), (5); 
RFAAX A, at 3-4.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag that occurs when a practitioner prescribes the 
same controlled substance in identical or substantially similar 
quantities to multiple patients. RFAAX A, at 5. Specifically, between 
January 2022 and June 2023, Registrant filled over 90 prescriptions for 
oxycodone issued by Dr. V.M. to C.W., D.S.T., D.W., E.W., J.L., J.R., 
and L.T. Id. Each prescription was for the highest strength of 
oxycodone, 30 mg, which is known to be frequently abused, and each 
prescription ranged from 98 to 105 dosage units. Id.
    Further, between January 2022 and June 2023, Registrant filled over 
30 prescriptions for hydrocodone-acetaminophen issued by Dr. V.M. to 
D.S.E., D.S.M., and J.J. Id. Each prescription was for the highest 
strength of hydrocodone-acetaminophen, 10/325 mg, which is known to be 
frequently abused, and the prescriptions ranged from 90 to 105 dosage 
units. Id.
    Accordingly, the Agency finds that Registrant filled over 120 
controlled substance prescriptions without first resolving the pattern 
prescribing red flags.

B. Prescriptions Lacking Specific Diagnosis

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[P]rescriptions for controlled substances by a 
prescriber presented to the pharmacy contain nonspecific or no 
diagnoses, or lack the intended use of the drug.'' 22 Tex. Admin. Code 
section 291.29(f)(4); RFAAX A, at 3.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of prescriptions lacking a specific diagnosis. 
RFAAX A, at 5. Specifically, between January 2022 and June 2023, 
Registrant filled prescriptions lacking specific diagnoses for all ten 
individuals \3\ for oxycodone 30 mg and hydrocodone-acetaminophen 10/
325 mg. Id. Accordingly, the Agency finds that Registrant filled 
controlled substance prescriptions without first resolving the red flag 
of prescriptions lacking a specific diagnosis.
---------------------------------------------------------------------------

    \3\ C.W., D.S.E., D.S.M., D.S.T., D.W., E.W., J.J., J.L., J.R., 
and L.T., the relevant individuals to whom prescriptions were 
improperly filled in this case, are referred to collectively as the 
ten individuals.
---------------------------------------------------------------------------

C. Shared Addresses

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[M]ultiple persons with the same address present 
substantially similar controlled substance prescriptions from the same 
practitioner.'' 22 Tex. Admin. Code section 291.29(f)(11); RFAAX A, at 
4.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of multiple persons with the same address 
presenting the same, or substantially similar, prescriptions from the 
same practitioner. RFAAX A, at 6. Specifically, between January 2022 
and June 2023, Registrant filled prescriptions for oxycodone 30 mg for 
C.W. and D.W., who both share the same address and received their 
prescriptions from the same practitioner, Dr. V.M. Id. Between January 
2022 and April 2023, Registrant filled prescriptions for hydrocodone-
acetaminophen 10/325 mg for D.S.M. and J.J., who both share the same 
address and received their prescriptions from the same practitioner, 
Dr. V.M. Id. Between February 2022 and June 2023, Registrant filled 
prescriptions for oxycodone 30 mg for J.R. and L.T., who both share the 
same address and received their prescriptions from the same 
practitioner, Dr. V.M. Id. Finally, between January 2022 and May 2023, 
Registrant filled prescriptions for hydrocodone-acetaminophen 10/325 mg 
for D.S.E. and J.L.,\4\ who both share the same address and received 
their prescriptions from the same practitioner, Dr. V.M. Id.
---------------------------------------------------------------------------

    \4\ The OSC also alleges, and it is therefore admitted, that 
Registrant filled oxycodone 30 mg for D.S.T. who shared an address 
with D.S.E. and J.L. and saw the same practitioner. Id. This 
allegation is not sustained because there is not substantial 
evidence or an admission that clearly establishes that hydrocodone-
acetaminophen 10/325 is a ``substantially similar controlled 
substance prescription'' to oxycodone 30 mg such that the 
prescription presents an additional instance of the shared address 
red flag. Id.
---------------------------------------------------------------------------

    Accordingly, the Agency finds that Registrant filled controlled 
substance prescriptions without first resolving the red flag of shared 
addresses.

[[Page 82269]]

D. Prescriber Area of Practice

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[T]he controlled substance(s) or the quantity of the 
controlled substance(s) prescribed are inconsistent with the 
practitioner's area of medical practice.'' 22 Tex. Admin. Code section 
291.29(f)(9); RFAAX A, at 6. Registrant is deemed to have admitted that 
between January 2022 and June 2023, Registrant repeatedly filled 
prescriptions for oxycodone and hydrocodone-acetaminophen issued by Dr. 
V.M., despite Dr. V.M. prescribing outside of her family and 
administrative medicine area of practice. RFAAX A, at 6.\5\ 
Accordingly, the Agency finds that Registrant filled controlled 
substance prescriptions without first resolving the red flag arising 
from the prescriber's area of practice.
---------------------------------------------------------------------------

    \5\ Texas regulations further identify as a red flag pattern, 
``[T]he practitioner's clinic is not registered as, and not exempted 
from registration as, a pain management clinic by the Texas Medical 
Board, despite prescriptions by the practitioner presented to the 
pharmacy indicating that the practitioner is mostly prescribing 
opioids, benzodiazepines, barbiturates, or carisoprodol, but not 
including suboxone, or any combination of these drugs.'' 22 Tex. 
Admin. Code section 291.29(f)(8). The OSC alleges, and it is 
therefore deemed admitted, that ``Dr. [V.M.] is not Board Certified 
in the area of pain management.'' RFAAX A, at 6. However, there is 
not substantial evidence or an admission that the prescriptions 
issued by Dr. V.M. that were presented to the Registrant were mostly 
for opioids and the other listed controlled substances. Accordingly, 
the Agency cannot sustain this allegation or find that it presents 
an additional instance of the prescriber area of practice red flag.
---------------------------------------------------------------------------

E. Long Distances

    Registrant is deemed to have admitted that individuals traveling 
long distances to obtain or fill controlled substance prescriptions is 
a well-known red flag of abuse or diversion. Registrant further admits 
that it repeatedly filled prescriptions without identifying and 
resolving the red flag of patients traveling long distances to obtain 
or fill controlled substance prescriptions. Id. at 7. Specifically, 
Registrant is deemed to have admitted that it filled prescriptions for 
seven individuals, C.W., D.W., D.S.M., J.J., E.W., J.R., and L.T., 
whose residences were in ``completely opposite areas of the Houston 
Metropolitan area'' from their physician's office (Dr. V.M.) and from 
their pharmacy (Registrant). Id. Registrant further admits that there 
were several pharmacies closer to both Dr. V.M.'s office and the seven 
individuals' residences. Id.
    Accordingly, the Agency finds that Registrant filled controlled 
substance prescriptions without first resolving the red flag arising 
from long distances traveled.

F. Cash Payments

    Texas regulations identify the following prescribing pattern as a 
red flag factor: ``[P]ersons consistently pay for controlled substance 
prescriptions with cash or cash equivalents more often than through 
insurance.'' 22 Tex. Admin. Code section 291.29(f)(12); RFAAX A, at 7-
8.
    Registrant is deemed to have admitted that it failed to identify 
and resolve the red flag of cash payments, which is a common red flag 
because it allows a patient to avoid the scrutiny associated with the 
use of insurance. Id. at 7-8. Specifically, between January 2022 and 
July 2023, Registrant routinely accepted cash payments for controlled 
substance prescriptions, including for each of the prescriptions filled 
for each of the ten individuals as described above. Id. at 8. 
Registrant is also deemed to have admitted that for L.T., Registrant 
routinely accepted cash payment for L.T.'s prescriptions between 
February 2022 and July 2023, despite the Texas Prescription Drug 
Monitoring Program Report indicating that L.T. used insurance at other 
pharmacies on three occasions.\6\ Id.
---------------------------------------------------------------------------

    \6\ The OSC additionally alleged, and it is therefore deemed 
admitted, that ``between January 2022 and July 2023, [Registrant] 
routinely dispensed a quantity less than the amount prescribed by 
the physician and provided no documentation regarding approval from 
the physician.'' Id. The OSC implies that this conduct violates 22 
Texas Administrative Code section 291.33(c)(2)(A)(iv), which states: 
``[P]rior to dispensing, any questions regarding a prescription drug 
order must be resolved with the prescriber and written documentation 
of these discussions made and maintained . . . .'' Id. It is not 
clear from substantial record evidence or an admission that the 
Registrant filling a quantity less than what was prescribed means 
that Registrant must have had unresolved questions regarding the 
prescription drug order. Accordingly, this allegation regarding the 
red flag of dispensing less than prescribed is not sustained. The 
Agency finds that the founded allegations discussed above are more 
than sufficient to support the Government's requested sanction of 
revocation under these circumstances.
---------------------------------------------------------------------------

    Accordingly, the Agency finds that Registrant filled controlled 
substance prescriptions without first resolving the red flag arising 
from cash payments.

G. Expert Review

    DEA retained an independent pharmacy expert who concluded that the 
above prescription data presented multiple red flags that were highly 
indicative of abuse and diversion. Id. Registrant is deemed to have 
admitted that these red flags were not resolved by a pharmacist acting 
in the usual course of professional practice prior to dispensing, and, 
therefore, that each prescription was filled outside the Texas standard 
of care. Id.

II. Discussion

A. The Five Public Interest Factors

    Under the Controlled Substances Act (CSA), ``[a] registration . . . 
to . . . dispense a controlled substance . . . may be suspended or 
revoked by the Attorney General upon a finding that the registrant . . 
. has committed such acts as would render [its] registration under [21 
CFR 823] inconsistent with the public interest as determined under such 
section.'' 21 U.S.C. 824(a). In making the public interest 
determination, the CSA requires consideration of the following factors:

    (A) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (B) The [registrant]'s experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The [registrant]'s conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(g)(1).
    The Agency considers these public interest factors in the 
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each 
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination 
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 
(1993).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(g)(1),\7\ the Government's evidence in support of its 
prima facie case for revocation of Registrant's registration is 
confined to Factors B and D. See

[[Page 82270]]

RFAAX A, at 4-5. Moreover, the Government has the burden of proof in 
this proceeding. 21 CFR 1301.44.
---------------------------------------------------------------------------

    \7\ As to Factor A, the record contains no evidence of a 
recommendation from any State licensing board or professional 
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an 
absence of such evidence ``does not weigh for or against a 
determination as to whether continuation of the [registrant's] DEA 
certification is consistent with the public interest.'' Roni 
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is 
no evidence in the record that Registrant has been convicted of an 
offense under either Federal or State law ``relating to the 
manufacture, distribution, or dispensing of controlled substances.'' 
21 U.S.C. 823(g)(1)(C). Agency cases have found that ``the absence 
of such a conviction is of considerably less consequence in the 
public interest inquiry'' and is therefore not dispositive. Dewey C. 
MacKay, M.D., 75 FR 49956, 49973 (2010). Finally, as to Factor E, 
the Government's evidence fits squarely within the parameters of 
Factors B and D and does not raise ``other conduct which may 
threaten the public health and safety.'' 21 U.S.C. 823(g)(1)(E). 
Accordingly, Factor E does not weigh for or against Registrant.
---------------------------------------------------------------------------

    Here, the Agency finds that the Government's evidence satisfies its 
prima facie burden of showing that Registrant's continued registration 
would be ``inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4).

B. Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21156, 21162 (2022). In the current matter, the Government has 
alleged that Registrant violated both Federal and State law regulating 
controlled substances. RFAAX A, at 2-4. Specifically, a pharmacist may 
only fill a prescription that was ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' Id. Sec.  1306.04(a). Although ``[t]he 
responsibility for the proper prescribing and dispensing of controlled 
substances is upon the prescribing practitioner . . . a corresponding 
responsibility rests with the pharmacist who fills the prescription.'' 
Id. Section 1306.04(a) prohibits ``a pharmacist from filling a 
prescription for a controlled substance when he either knows or has 
reason to know that the prescription was not written for a legitimate 
medical purpose.'' Wheatland Pharmacy, 78 FR 69441, 69445 (2013) 
(internal quotations and alterations omitted); RFAAX 2, at 2. DEA 
regulations require ``pharmacists to identify and resolve suspicions 
that a prescription is illegitimate.'' Trinity Pharmacy II, 83 FR 7304, 
7331 (2018); RFAAX 2, at 2. Further, under Federal regulations, a 
prescription for a controlled substance ``may only be filled by a 
pharmacist, acting in the usual course of his professional practice.'' 
21 CFR 1306.06.
    As for State law, under Texas regulations, ``[a] pharmacist may not 
dispense . . . a controlled substance . . . except under a valid 
prescription and in the course of professional practice.'' Tex. Health 
& Safety Code section 481.074(a). Regarding the specific standards for 
a pharmacist filing a new or refill prescription, ``[f]or the purpose 
of promoting therapeutic appropriateness, a pharmacist shall, prior to 
or at the time of dispensing a prescription drug order, review the 
patient's medication record. Such review shall at a minimum identify 
clinically significant: . . . (III) reasonable dose and route of 
administration; . . . (VI) drug-drug interactions; . . . [and] (X) 
proper utilization, including overutilization or underutilization.'' 22 
Tex. Admin. Code section 291.33(c)(2)(A)(i). ``Upon identifying any 
clinically significant conditions [or] situations . . . the pharmacist 
shall take appropriate steps to avoid or resolve the problem including 
consultation with the prescribing practitioner.'' Id. section 
291.33(c)(2)(A)(ii). ``Prior to dispensing, any questions regarding a 
prescription drug order must be resolved with the prescriber and 
written documentation of these discussions made and maintained.'' Id. 
section 291.33(c)(2)(A)(iv); see also id. sections 291.29(a)-(b), 
291.33(c)(2)(C) (describing the requirements for documentation).
    Regarding ``red flag factors'' that are ``relevant to preventing 
the non-therapeutic dispensing of controlled substances,'' Texas 
regulations identify the following relevant circumstances as red flags:

    (1) the pharmacy dispenses a reasonably discernible pattern of 
substantially identical prescriptions for the same controlled 
substances, potentially paired with other drugs, for numerous 
persons, indicating a lack of individual drug therapy in 
prescriptions issued by the practitioner; . . .
    (3) prescriptions by a prescriber presented to the pharmacy are 
routinely for controlled substances commonly known to be abused 
drugs, including opioids, benzodiazepines, muscle relaxants, 
psychostimulants, and/or cough syrups containing codeine, or any 
combination of these drugs;
    (4) prescriptions for controlled substances by a prescriber 
presented to the pharmacy contain nonspecific or no diagnoses, or 
lack the intended use of the drug;
    (5) prescriptions for controlled substances are commonly for the 
highest strength of the drug and/or for large quantities (e.g., 
monthly supply), indicating a lack of individual drug therapy in 
prescriptions issued by the practitioner; . . .
    (8) the practitioner's clinic is not registered as, and not 
exempted from registration as, a pain management clinic by the Texas 
Medical Board, despite prescriptions by the practitioner presented 
to the pharmacy indicating that the practitioner is mostly 
prescribing opioids . . . ;
    (9) the controlled substance(s) or the quantity of the 
controlled substance(s) prescribed are inconsistent with the 
practitioner's area of medical practice; . . .
    (11) multiple persons with the same address present 
substantially similar controlled substance prescriptions from the 
same practitioner; [and]
    (12) persons consistently pay for controlled substance 
prescriptions with cash or cash equivalents more often than through 
insurance.''

    Id. section 291.29(f). Further, under Texas regulations, ``[a] 
pharmacist shall not dispense a prescription drug if the pharmacist 
knows or should know the prescription drug order is fraudulent or 
forged.'' Id.
    Here, Registrant has admitted that it repeatedly filled 
prescriptions for controlled substances that contained multiple red 
flags of abuse and/or diversion without addressing or resolving those 
red flags. RFAAX A, at 5-8. DEA's pharmacy expert concluded that these 
red flags were highly indicative of abuse and diversion. Id. at 8. 
Registrant has further admitted that none of the above-referenced 
controlled substance prescriptions were filled for a legitimate medical 
purpose in the usual course of professional practice. Id. As such, the 
Agency finds that Registrant violated 21 CFR 1306.04, 1306.06, Texas 
Health & Safety Code section 481.074, and 22 Texas Administrative Code 
sections 291.29, 291.33.
    Accordingly, the Agency finds that Factors B and D weigh in favor 
of revocation of Registrant's registration and thus finds Registrant's 
continued registration to be inconsistent with the public interest in 
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds 
that Registrant failed to provide any evidence to rebut the 
Government's prima facie case.

III. Sanction

    Where, as here, the Government has established grounds for 
revocation, the burden shifts to the registrant to show why it can be 
entrusted with the responsibility carried by a registration. Garret 
Howard Smith, M.D., 83 FR 18882, 18910 (2018). To establish that it can 
be entrusted with registration, a registrant must both accept 
responsibility and demonstrate that it has undertaken corrective 
measures. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 
FR 62316, 62339 (2012) (internal quotations omitted); see also Michele 
L. Martinho, M.D., 86 FR 24012, 24019 (2021); George D. Gowder, III, 
M.D., 89 FR 76152, 76154 (2024). Trust is necessarily a fact-dependent 
determination based on individual circumstances; therefore, the Agency 
looks at factors such as the acceptance of responsibility, the 
credibility of that acceptance as it relates to the probability of 
repeat violations or behavior, the nature of the misconduct that forms 
the basis for sanction, and the Agency's interest in deterring similar 
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33738, 33746 
(2021).
    Here, Registrant failed to answer the allegations contained in the 
OSC/ISO

[[Page 82271]]

and did not otherwise avail itself of the opportunity to refute the 
Government's case. As such, Registrant has made no representations as 
to its future compliance with the CSA nor made any demonstration that 
it can be entrusted with registration. Moreover, the evidence presented 
by the Government shows that Registrant violated the CSA, further 
indicating that Registrant cannot be entrusted.
    Accordingly, the Agency will order the revocation of Registrant's 
registration.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FH9037830 issued to Halowells Pharmacy. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I 
hereby deny any pending applications of Halowells Pharmacy to renew or 
modify this registration, as well as any other pending application of 
Halowells Pharmacy for additional registration in Texas. This Order is 
effective November 12, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 4, 2024, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-23495 Filed 10-9-24; 8:45 am]
BILLING CODE 4410-09-P