AMENDMENT 723

Amendment: Section 2N2.1 is amended by redesignating subsection (b) as subsection (c) and inserting after subsection (a) the following:

"(b) Specific Offense Characteristic

(1) If the defendant was convicted under 21 U.S.C. § 331 after sustaining a prior conviction under 21 U.S.C. § 331, increase by 4 levels.".

The Commentary to §2N2.1 captioned "Application Notes" is amended in Note 2 by striking "(b)(1)" and inserting "(c)(1)"; and by striking "(b)(2)" and inserting "(c)(2)".

The Commentary to §2N2.1 captioned "Application Notes" is amended in Note 3 by striking "Death" and inserting "The offense created a substantial risk of bodily injury or death;"; by inserting "death," before "extreme"; and by inserting "from the offense" after "resulted".

Reason for Amendment: This amendment makes two changes to §2N2.1 (Violations of Statutes and Regulations Dealing With Any Food, Drug, Biological Product, Device, Cosmetic, or Agricultural Product) to address offenses under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the "FDCA") and the Prescription Drug Marketing Act of 1987, Pub L. 100–293 (the "PDMA"). First, the amendment adds a specific offense characteristic at subsection (b)(1) of §2N2.1 that provides a four-level enhancement for repeat violations of the FDCA. First time violations of the FDCA, absent fraud, carry a maximum term of imprisonment of one year. 21 U.S.C. § 333(a)(1). In contrast, second or subsequent violations of the FDCA carry a maximum term of imprisonment of three years. 21 U.S.C. § 333(a)(2). The Commission determined based on public comment and testimony that an enhancement is appropriate to account for the increased statutory maximum penalties provided for second or subsequent FDCA violations.

Second, the amendment expands the upward departure provision at Application Note 3(A) of §2N2.1 to include an offense that created a substantial risk of bodily injury or death. Public comment and testimony indicated that §2N2.1 may not adequately account for the substantial risk of bodily injury or death created by certain offenses. The PDMA, for example, includes certain offenses that may create such risks, such as the re-importation into the United States of any previously exported prescription drug, except by the drug's manufacturer; the sale or purchase of any prescription drug sample or coupon; and the wholesale distribution of prescription drugs without the necessary state or federal licenses. 21 U.S.C. § 353(c), (d), (e). Thus, the amendment expanded the scope of the upward departure provision to address such risks.

Effective Date: The effective date of this amendment is November 1, 2008.