Notice2024-30019
Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 17, 2024
Effective
December 17, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
This final order establishes the final adjusted 2024 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 242 (Tuesday, December 17, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Notices]
[Pages 102638-102649]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30019]
[[Page 102637]]
Vol. 89
Tuesday,
No. 242
December 17, 2024
Part IX
Department of Justice
-----------------------------------------------------------------------
Drug Enforcement Administration
-----------------------------------------------------------------------
Final Adjusted Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024;
Established Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2025;
Notices
Federal Register / Vol. 89 , No. 242 / Tuesday, December 17, 2024 /
Notices
[[Page 102638]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1228F]
Final Adjusted Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: This final order establishes the final adjusted 2024 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: This order is effective December 17, 2024.
FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish production quotas for each
basic class of controlled substances listed in schedules I and II and
for ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney
General has delegated this function to the Administrator of the Drug
Enforcement Administration (DEA) pursuant to 28 CFR 0.100.
Background
DEA published the 2024 established aggregate production quotas
(APQs) for controlled substances in schedules I and II and for the
assessment of annual needs (AAN) for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine in the Federal Register (FR)
on January 3, 2024.\1\ This notice stated that the Administrator would
adjust, as needed, the established APQ in 2024 in accordance with 21
CFR 1303.13 and 21 CFR 1315.13. DEA is committed to preventing and
limiting diversion by enforcing laws and regulations regarding
controlled substances and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, while meeting the legitimate
medical, scientific, and export needs of the United States.
---------------------------------------------------------------------------
\1\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2024, 89 FR 407.
---------------------------------------------------------------------------
The 2024 proposed adjusted APQ for controlled substances in
schedules I and II and AAN for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine were subsequently published in
the Federal Register on September 25, 2024 \2\ after consideration of
the criteria outlined in that notice. All interested persons were
invited to comment on or object to the proposed APQs and AANs on or
before October 25, 2024. Prior to this notice, DEA also published a
final order to increase the 2024 APQ for lisdexamfetamine and d-
amphetamine (for conversion).\3\ Therefore, DEA proposed no additional
changes for those substances.
---------------------------------------------------------------------------
\2\ Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2024, 89 FR 78764 (September 25, 2024).
\3\ Adjustment to the Aggregate Production Quota for
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR
72424 (Sept. 5, 2024).
---------------------------------------------------------------------------
Comments Received
DEA received 20 timely comments in response to the September
Federal Register notice, from chronic pain patients and DEA-registered
entities. The comments included requests to ensure sufficient
availability in the APQ for select schedule I and schedule II
controlled substances including increasing specific APQs if necessary;
requests that DEA utilize its regulatory authority in additional ways;
opioid shortage concerns; and comments outside the scope of this final
order. DEA restricted three comments from public view due to
confidential business information and/or confidential personal
identifying information.
DEA's Regulatory Authority
Issue: DEA-registered manufacturers requested the APQs for 4-
Anilino-N-Phenethyl-4-Piperidine, fentanyl, hydromorphone, morphine
(for conversion), oxymorphone (for conversion), and sufentanil be
reviewed for sufficiency and adjusted if necessary.
DEA Response: DEA sets the APQs in a manner to meet the estimated
medical, scientific, research, industrial needs of the United States,
lawful export requirements, and for the establishment and maintenance
of reserve stocks. As of the date the comment period closed for the
proposed adjusted 2024 APQ and AAN, DEA believes that the proposed
adjusted 2024 APQs are sufficient to meet the current estimated 2024
legitimate medical, scientific, research, and industrial needs of the
United States, for lawful export requirements, and to provide for
adequate reserve stock.
Issue: A DEA-registered manufacturer suggested several changes that
it believes are necessary to deter companies from using the quota
process to gain competitive advantage and to ensure that quota is
available when supply chain circumstances change. Among these, the
commenter suggested that DEA needs to obtain authority to reallocate
manufacturing quota from one registered bulk manufacturer to another in
the event that a finished dosage form manufacturer wishes, midyear, to
procure bulk material from a different bulk manufacturer than
originally planned.
DEA Response: This comment is outside the scope of the current
action, but DEA notes the commenter's suggestion for future
consideration. DEA currently can reallocate or revoke quotas in
specific circumstances as discussed in 21 CFR 1303.26 and 1303.36.
Issue: The same commenter who raised the immediately preceding
issue also suggested that DEA should change the procurement quota
application form (DEA Form 250) so that applicants can specify multiple
suppliers from which they may procure a basic class of bulk controlled
substance, as well as the estimated timeframe for receipt of the basic
class from each supplier.
DEA Response: The current procurement quota application form (DEA
Form 250) allows for the applicants to specify multiple suppliers from
which they may procure a basic class of bulk controlled substance, as
well as the estimated timeframe for receipt of the basic class from
each supplier.
Issue: The same commenter who raised the two immediately preceding
issues suggested that DEA specify, when granting quota, to which
specific finished dosage forms the quota is to be applied and the
proportion of the authorized amount that is to be used toward each
identified dosage form. The manufacturer further requested that DEA
verify during DEA inspections the manufacturer's compliance with the
details specified in the quota grant.
DEA Response: In 21 U.S.C. 826(a)(2), Congress granted DEA the
authority to delineate quota by pharmaceutical dosage form (tablets,
capsules, oral
[[Page 102639]]
liquids, etc.) if DEA determines it will assist in avoiding
overproduction, shortages, or diversion of a controlled substance. DEA
currently believes the designation of quota by dosage forms at the bulk
manufacturing level could lead to unforeseen circumstances such as
interference with production schedules or hindrance of the supply
chain. Moreover, in compliance with Congress's directive, DEA would
need to consider whether the application of such detail to quotas would
assist in avoiding overproduction, shortages, or diversion.
When a manufacturer has several customers that use the same active
pharmaceutical ingredient (API) to manufacture similar dosage forms
(i.e. brand and generic formulations), the terms of the contractual
agreements govern the transaction in normal circumstances. DEA does not
grant quota to fulfill specific business contracts between registrants;
rather, DEA grants quota to meet the legitimate medical, scientific,
research, and export requirements while ensuring the ability to
maintain adequate reserve stock.
Issue: The same commenter who raised the three immediately
preceding issues suggested that DEA assess ``quota usage'' on a
quarterly or semi-annual basis to verify that manufacturers timely
distribute materials that they are authorized under quota to
manufacture, and to require companies to surrender unused quotas so
that those unused amounts can be reassigned to others who can then
supply the market.
DEA Response: DEA has in the past and will continue to ask
manufacturers to surrender quota that they will not be able to utilize
in a timely manner (e.g., due to production scheduling issues,
malfunctioning of manufacturing lines, etc.). While DEA will note for
potential future consideration the commenter's suggestion that DEA
periodically assess quota usage, in a series of meetings held in the
spring of 2024, numerous API and dosage form manufacturers informed DEA
that a requirement to utilize quota quarterly would not be feasible
because of limited capacity of production lines and manufacturers'
strict adherence to production schedules. As a result of the
discussion, DEA is allotting commercial manufacturing procurement
quotas for Schedule II non-injectable products on a semi-annual basis.
Opioid Shortage Concerns
Issue: Nine commenters expressed general concerns regarding a
perceived nationwide shortage of opioid medication due to patients
experiencing intermittent out-of-stock or back-ordered situations at
pharmacies while attempting to fill their prescriptions.
DEA Response: DEA utilizes the available, reliable data and
information received by the agency in advance of publication; however
drug shortages may occur due to factors outside of DEA's control such
as manufacturing and quality problems, processing delays, supply chain
disruptions, or discontinuations. In such circumstances, if the drug
manufacturer notifies the U.S. Food and Drug Administration (FDA) Drug
Shortage Staff, FDA will coordinate with DEA to address and minimize
the impact of drug shortages if both agencies believe action is
warranted. Currently, FDA has not issued notice of any nationwide
shortages of the type of opioid medications mentioned by these
commenters.
Out of Scope Comments: DEA received other comments that were
general in nature and raised issues with respect to specific medical
illnesses and medical treatments. All of the issues raised are outside
of the scope of this final order for 2024 and do not impact the
analysis involved in finalizing the 2024 APQs.
Analysis for Final Adjusted 2024 Aggregate Production Quotas and
Assessment of Annual Needs
In determining the final adjusted 2024 APQs and AANs, DEA has
considered the above comments relevant to this final order for calendar
year 2024, along with the factors set forth in 21 CFR 1303.13 and 21
CFR 1315.13, in accordance with 21 U.S.C. 826(a). DEA has also
considered other relevant factors, including the 2023 year-end
inventories, initial 2024 manufacturing and import quotas, 2024 export
requirements, actual and projected 2024 sales, research and product
development requirements, additional applications received, and the
extent of any diversion of the controlled substance in the class. Based
on all of the above, the Administrator is finalizing the adjusted APQs
in the same amounts as proposed.
On July 29, 2024, DEA published a temporary scheduling order
placing N-desethyl isotonitazene and N-piperidinyl etonitazene in
schedule I of the CSA,\4\ and on October 25, 2024, DEA published a
final rule placing ethylphenidate in schedule I of the CSA,\5\ making
all regulatory controls pertaining to schedule I controlled substances
applicable to the manufacture of these substances, including the
requirement to establish an APQ pursuant to 21 U.S.C. 826 and 21 CFR
part 1303. This final order establishes an APQ for these substances for
the first time.
---------------------------------------------------------------------------
\4\ Schedules of Controlled Substances: Temporary Placement of
N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule
I, 89 FR 60817.
\5\ Schedules of Controlled Substances: Placement of
Ethylphenidate in Schedule I, 89 FR 84281.
---------------------------------------------------------------------------
Pursuant to the above, the Administrator hereby finalizes the 2024
APQs for the following schedule I and II controlled substances and the
2024 AANs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in grams of anhydrous acid or base, as
follows:
BILLING CODE 4410-P
[[Page 102640]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.086
[[Page 102641]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.087
[[Page 102642]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.088
[[Page 102643]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.089
[[Page 102644]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.090
[[Page 102645]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.091
[[Page 102646]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.092
[[Page 102647]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.093
[[Page 102648]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.094
BILLING CODE 4410-C
The Administrator also establishes that APQs for all other schedule
I and II controlled substances included in 21
[[Page 102649]]
CFR 1308.11 and 1308.12 remain at zero.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 13, 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. 2024-30019 Filed 12-16-24; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on December 17, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.