Why It Matters
Pharmacies that submit false registration information to the Drug Enforcement Administration are subject to fines under the federal criminal fine provisions rather than the former fixed $30,000 cap, following a DEA-conforming amendment that took effect Nov. 2.
The change closes a 24-year regulatory gap: The Criminal Law Technical Amendments Act of 2002 replaced the fixed dollar figures in the underlying Controlled Substances Act (CSA) on Nov. 2, 2002, but DEA's regulations retained the superseded $30,000 amounts until this rule, published exactly 24 years later. DEA states the rule "merely codifies legal requirements that have been in effect since 2002" and anticipates no economic impact.
The Big Picture
Three provisions in 21 C.F.R. § 1301.17 are affected: the affidavit for new pharmacy registration, the affidavit for transfer of pharmacy registration, and the prohibition on obtaining controlled substances through fraudulent registration. Each provision previously referenced a maximum fine of $30,000; each now refers to "title 18, United States Code," the federal criminal fine provisions, without stating a fixed dollar ceiling in the regulatory text.
DEA invoked the Administrative Procedure Act's good-cause exception to skip notice and comment, finding that notice and comment were "unnecessary" because the statutory change "has already been in effect since November 2, 2002" and affected parties would not need time to adjust their behavior. The agency did not solicit public comments on the conforming amendment.
The Law Now and After
Before the rule, all three penalty provisions in § 1301.17 referenced a fixed maximum fine: Paragraphs (a) and (b) read "a fine of not more than $30,000," and paragraph (d) read "a fine not exceeding $30,000."
Each of those phrases now reads "a fine under title 18, United States Code," replacing the outdated $30,000 figure with a reference to federal criminal fine provisions. The three provisions cover penalties for false information in pharmacy registration affidavits, fraudulent use of the affidavit procedure, and obtaining controlled substances through fraudulent registration.
What DEA Says
DEA states it "is not exercising discretion with this final rule because this final rule merely amends the regulations to conform to the change to the CSA made by the Technical Amendments Act." The agency adds that the rule "amends DEA regulations only to the extent necessary to be consistent with current Federal law, as modified by the Technical Amendments Act."
DEA determined the rule is not a significant regulatory action under Executive Order 12866 and did not submit it to the Office of Management and Budget for review. DEA also states the rule does not impose record-keeping or reporting requirements on state or local governments, individuals, businesses, or organizations, and that it will not have an annual effect on the economy of $100 million or more.
The Bottom Line
The rule took effect Nov. 2, the date of publication, with no phased compliance schedule. Because DEA bypassed notice and comment under the good-cause exception, the agency did not establish a public comment period for the amendment.
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