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

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Legal Authority and Background

Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas (APQ) for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA pursuant to 28 CFR 0.100.

DEA established the 2024 APQ for substances in schedules I and II and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on January 3, 2024. That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all APQ and AAN are subject to adjustment. DEA published a Final Order revising the 2024 lisdexamfetamine and d-amphetamine (for conversion) APQ on September 5, 2024.

Analysis for Proposed Adjusted 2024 Aggregate Production Quotas and Assessment of Annual Needs

DEA proposes to adjust the established 2024 APQ for certain schedule I and II controlled substances and the AAN for certain list I chemicals to be manufactured in the United States in 2024 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.

Factors for Determining the Proposed Adjustments

In determining the proposed adjustments, the Administrator has taken into account the factors in 21 CFR 1303.13 (adjustment of APQ for controlled substances) and 21 CFR 1315.13 (adjustment of the AAN for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator is authorized to increase or reduce the APQ and the AAN at any time.

DEA determined whether to propose an adjustment of the APQ for 2024 by considering the factors found at 21 CFR 1303.13(b):

(1) Changes in the demand for that class, changes in the national rate of net disposal of the class, changes in the rate of net disposal of the class by registrants holding individual manufacturing quotas for that class, and changes in the extent of any diversion in the class;

(2) Whether any increased demand for that class, the national and/or individual rates of net disposal of that class are temporary, short term, or long term;

(3) Whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to [21 CFR] 1303.24(b);

(4) Whether any decreased demand for that class will result in excessive inventory accumulation by all persons registered to handle that class (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to [21 CFR] 1303.24(b) or abandoned pursuant to [21 CFR] 1303.27;

(5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

DEA also considered updated information obtained from 2023 year-end inventories, 2023 disposition data submitted by quota applicants, changes in estimates of the medical needs of the United States, export requirements, and other information made available to DEA after the initial APQ and AAN had been established. Additional factors the Administrator considered in calculating the APQ, but not the AAN, include product development requirements of both bulk and finished dosage form manufacturers.

After considering the changes in the extent of diversion of all controlled substances, as required by 21 CFR 1303.13(b)(1), DEA has determined that any changes from the initial calculations are slight and not statistically significant from the estimates of diversion that DEA applied to the initial APQ valuations.

DEA determined whether to propose an adjustment of the AAN for 2024 by considering the factors found at 21 CFR 1315.13(b) and summarized below:

(1) Changes in the demand for that chemical, changes in the national rate of net disposal of the chemical, and changes in the rate of net disposal of the chemical by registrants holding individual manufacturing or import quotas for that chemical;

(2) Whether any increased demand for that chemical, the national and/or changes in individual rates of net disposal of that chemical are temporary, short term, or long term;

(3) Whether any increased demand for that chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to [21 CFR] 1315.24(b);

(4) Whether any decreased demand for that chemical will result in excessive inventory accumulation by all persons registered to handle that chemical (including manufacturers, distributors, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to [21 CFR] 1315.24(b) or abandoned pursuant to [21 CFR] 1315.27;

(5) Other factors affecting medical, scientific, research, industrial, and importation needs in the United States, lawful export requirements, and reserve stocks, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemical or the substances that are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

In evaluating whether there is a need for adjustment of the 2024 AAN for list I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 AAN. DEA considered the total net disposals of the list I chemicals for the current and preceding two years, actual and estimated inventories, projected demand, industrial use, and export requirements from data provided by DEA registered manufacturers and importers on the relevant quota application forms.

Additional Considerations Applicable to Covered Controlled Substances

When setting APQ, the Administrator must estimate the amount of diversion of any substance that is considered a “covered controlled substance.” The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. DEA is required to “make appropriate quota reductions, as determined by the [Administrator], from the quota the [Administrator] would have otherwise established had such diversion not been considered.” When estimating diversion, the Administrator “shall consider information” that she, in consultation with the Secretary of Health and Human Services, “determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States;” and “may take into consideration” whatever other sources of information she determines reliable.

DEA sent letters to the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the states in March, April, and May 2024 requesting overdose death and overprescribing data that could be considered in estimating diversion. DEA received information from the CDC in May 2024, the FDA in June 2024, and has begun receiving Prescription Data Monitoring Program (PDMP) data from the states. DEA considered this information in developing the estimates of diversion for the five covered controlled substances for this proposed adjustment.

DEA also aggregated data for each covered controlled substance from Drug Theft and Loss Reports to determine the estimates of diversion. DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA calculated the metric weight in grams of each active pharmaceutical ingredient (API) of the controlled substances being diverted as identified in these reports. In calculating the estimates of diversion, DEA utilized the same methodology as published in the Proposed 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. Below, DEA provides an updated chart showing estimations of diversion for each of the covered controlled substances.