Please note that all comments received in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available for public inspection online at https://www.regulations.gov, unless reasonable cause is given. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want to be made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted. DEA will post only the redacted comment on http://www.regulations.gov for public inspection. DEA generally will not redact additional information contained in the comment marked “TO BE PUBLICLY POSTED.” The Freedom of Information Act applies to all comments received. The Freedom of Information Act applies to all comments received.

For easy reference, an electronic copy of this document and supplemental information to this proposed rule are available at https://www.regulations.gov.

The Controlled Substances Act (CSA) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA any compound, mixture, or preparation containing certain nonnarcotic controlled substances if she finds that it is both (1) approved for prescription use, and (2) contains one or more other active ingredients which are not listed in any schedule and which are included in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse. 1 The Attorney General has delegated this authority to the Administrator of DEA (Administrator). 2 The Administrator may also revoke a previously granted exemption by following the same procedures that are used to evaluate an application for exemption—namely, by publishing in the Federal Register a general notice of the proposed rulemaking (NPRM) for revoking the exemption, permitting interested persons to file written comments on or objections to the proposed revocation, considering any comments submitted, and publishing a final order in the Federal Register that sets forth the findings of fact and conclusions of law upon which the order is based. 3

This notice proposes to revoke the exemption status for certain prescription products previously granted exemption because the National Drug Codes (NDCs) of these products are no longer active and/or the companies that originally filed for their exemption are no longer in existence. If finalized, this action will revoke the exemption status for a number of products and remove them from DEA's Table of Exempted Prescription Products list. While this action would revoke the exemption status, this action should have no effect on these products because they are no longer marketed.

DEA has exempted prescription drug products from certain parts of the CSA when the products meet the requirements for exemption, including the requirement to contain active ingredients believed to vitiate the potential for abuse. The current table of products that have been granted exempted prescription product status, pursuant to 21 CFR 1308.31 and 1308.32, can be found on the DEA Diversion Control Division website. 4

Butalbital is classified as an intermediate acting barbiturate. Butalbital is a schedule III nonnarcotic controlled substance that falls under DEA Administration Controlled Substances Code Number 2100, as it is a derivative of barbituric acid. 5 Originally, some butalbital prescription products were excepted by the Bureau of Drug Abuse Control (BDAC) of the Food and Drug Administration (FDA), the predecessor to the Bureau of Narcotics and Dangerous Drugs and later DEA. A panel of public health physicians and FDA medical officers developed the criteria used to exempt butalbital prescription products by BDAC in 1967. These criteria were based upon the expectation that combining the controlled substance with an amount of counteractive drug sufficient to cause early deterrent side effects would vitiate the potential for abuse. For products containing long or intermediate acting barbiturates in combination with analgesics, the criteria provided that an exception would be granted if, for every 15 mg of barbiturate, the product contained at least (1) 188 mg aspirin; (2) 375 mg salicylamide; or (3) 70 mg phenacetin, acetanilid, or acetaminophen.

Following the establishment of the criteria, DEA approved subsequent applications by new manufacturers based upon the same criteria, whereby the inclusion of these other active ingredients was thought to be in sufficient quantities to vitiate the potential for abuse. The criteria developed in 1967 was originally found to meet the standard for exemption currently described in 21 U.S.C. 811(g)(3)(A), such that if a prescription drug was found to meet the 1967 criteria for exception, then it also met the test to contain an ingredient that vitiated the potential for abuse under the CSA standard.

Currently, there are 189 butalbital products listed by their NDC on DEA's Table of Exempted Prescription Products. Using the FDA's National Drug Code Directory  6 and the U.S. National Institute of Health-National Library of Medicines DailyMed database, 7 DEA determined that 160 of the NDCs correlating to butalbital products on the exempt prescription product list are no longer active and marketed. DEA confirmed with FDA these products are no longer marketed. Therefore, DEA is proposing to remove these inactive products from the exempted prescription product list for clarity and to accurately portray which products are currently on the market. DEA welcomes comments from any company who believes their product is being erroneously removed from the exempt prescription product list because their product is still available for sale.

For reasons detailed above, DEA is removing the following prescription products from DEA's Table of Exempted Prescription Products, as set forth below:

DEA has determined that this proposed rulemaking is not a “significant regulatory action” under section 3(f) of E.O. 12866, Regulatory Planning and Review. This proposed rule has been drafted and reviewed in accordance with E.O. 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation and E.O. 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation. This action is also not subject to E.O. 14192, “Unleashing Prosperity Through Deregulation,” or E.O 14294, “Fighting Overcriminalization in Federal Regulations,” as this action is neither a deregulation nor invokes criminal penalties.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Administrator, in accordance with the Regulatory Flexibility Act, 8 has reviewed this proposed rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. There would be no economic impact because the products being removed from DEA's prescription product exempt list are no longer marketed.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 9 DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year . . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.