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17.

Sample Charges for GHB Felony Cases

NOTE: GHB misdemeanor cases are identical, except that the element of "intent to defraud and mislead" is not present, so that language would be deleted from the charging document, and, for a misdemeanor, the citation would be to 21 U.S.C. § 333(a)(1) rather than to § 333(a)(2).

INTRODUCTORY ALLEGATIONS

At times relevant to this Indictment:

x. The United States Food and Drug Administration ("FDA") was the federal agency charged with the responsibility of protecting the health and safety of the American public under the Federal Food, Drug, and Cosmetic Act.

x. Articles known under the names gamma hydroxybutyrate, 4-hydroxybutyric acid monosodium salt, gamma hydroxybutyric acid sodium salt, and sodium oxybate (hereinafter referred to collectively as "GHB"), were drugs within the meaning of Title 21, United States Code, Section 321(g)(1)(C), in that they were intended to affect the structure and any function of the body of man, and within the meaning of Title 21, United States Code, Section 321(g)(1)(D), in that they were intended for use as a component of any article intended to affect the structure and any function of the body of man.

COUNT 1
INTERSTATE DISTRIBUTION OF GHB WITH INTENT TO DEFRAUD AND MISLEAD
(appropriate when unlabeled GHB is distributed in interstate commerce -- and actions are taken to hide the activity or there is evidence that the distributor knew that ghb was dangerous and did not warn consumers of those dangers)

x. On or about February 4, 1993, within the xxxxxxx District of xxxxx, and elsewhere, defendant xxxxx did, with the intent to defraud and mislead, cause to be introduced into interstate commerce from xxxxxx, to xxxxxx, fifty bottles each containing approximately 100 grams of the drug GHB which, when introduced and delivered for introduction into interstate commerce, were misbranded as follows:
(a) within the meaning of Title 21, United States Code, Section 352(b) in that they were in package form and did not bear labels containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, and numerical count;
(b) within the meaning of Title 21, United States Code, Section 352(e)(1)(A) in that they did not bear labels containing the established name of the drug, as the term "established" is defined in Title 21, United States Code, Section 352(e)(3);
(c) within the meaning of Title 21, United States Code, Section 352(f)(1) in that its labeling did not bear adequate directions for use; and,
(d) within the meaning of Title 21, United States Code, Section 352(f)(2), in that its labeling did not bear such adequate warnings against use in those pathological conditions, and by children where its use may be dangerous to health, and against unsafe dosage and methods and duration of administration and application, in such manner and form, as are necessary for the protection of users.

In violation of Title 21, United States Code, Sections 331(a) and 333(a)(2), and Title 18, United States Code, Section 2.

COUNT 2
INTRASTATE DISTRIBUTION OF GHB AFTER RECEIPT FROM INTERSTATE COMMERCE -- DONE WITH THE INTENT TO DEFRAUD AND MISLEAD
(appropriate when GHB or one if its components is received from interstate commerce and subsequently sold within state -- done with intent to defraud and mislead)

x. On or about xxxx, within the District of xxx and elsewhere, defendant xxxx did, with the intent to defraud and mislead and while held for sale after one or more of its components had been shipped in interstate commerce, cause the manufacture, processing, packing, selling, and failing to adequately label (include appropriate verb) of a drug product containing GHB, which acts resulted in such drug product to be misbranded as follows:

(a) within the meaning of Title 21, United States Code, Section 352(b) in that they were in package form and did not bear labels containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, and numerical count;

(b) within the meaning of Title 21, United States Code, Section 352(e)(1)(A) in that they did not bear labels containing the established name of the drug, as the term "established" is defined in Title 21, United States Code, Section 352(e)(3);

(c) within the meaning of Title 21, United States Code, Section 352(f)(1) in that its labeling did not bear adequate directions for use; and

(d) within the meaning of Title 21, United States Code, Section 352(f)(2), in that its labeling did not bear such adequate warnings against use in those pathological conditions, and by children where its use may be dangerous to health, and against unsafe dosage and methods and duration of administration and application, in such manner and form, as are necessary for the protection of users.

In violation of Title 21, United States Code, Sections 331(k) and 333(a)(2), and Title 18, United States Code, Section 2.

COUNT 3
OPERATING AN UNREGISTERED DRUG FACILITY
(appropriate when there is evidence that target manufactured GHB for commercial distribution and took actions to hide the activity)

x. Beginning on or before xxxxx, and ending on or about xxxxx, at or near xxxx, in the District of Arizona, defendant xxxxx, with the intent to defraud and mislead, did operate and cause to be operated an establishment at xxxxxx, at which establishment defendant xxxxx manufactured, prepared, propagated, compounded, and processed GHB, a drug within the meaning of Title 21, United States Code, Section 321(g), without having registered such establishment as required under Title 21, United States Code, Section 360(b) and (c).

All in violation of Title 21, United States Code, Sections 331(p) and 333(a)(2), and Title 18, United States Code, Section 2.

COUNT 4
RECEIPT OF MISBRANDED GHB FROM INTERSTATE COMMERCE AND PROFFER FOR SALE
(appropriate when there is evidence defendant received packaged GHB from interstate commerce and sold the GHB)

x. On or about xxxxxx, within the Northern District of Alabama and elsewhere, the defendant xxxx, with the intent to defraud and mislead, received the drug GHB in interstate commerce. When received, the drug was misbranded in the following ways:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that its labeling did not bear adequate directions for use; and

(b) within the meaning of Title 21, United States Code, Section 352(f)(2) in that its labeling did not bear such adequate warnings against use in those pathological conditions, and by children where its use may be dangerous to health, and against unsafe dosage and methods and duration of administration and application, in such manner and form, as are necessary for the protection of users.

Thereafter, the defendant xxxxx delivered such misbranded drug and proffered delivery thereof for pay and otherwise.

All in violation of Title 21, United States Code, Sections 331(c) and 333(a)(2) and Title 18, United States Code, Section 2.

COUNT 5
INTERSTATE DISTRIBUTION OF "UNAPPROVED NEW DRUG"
(appropriate when there is evidence that defendant distributed GHB with a label or other "labeling" that contained conditions prescribed, recommended, or suggested - and evidence of intent to defraud and mislead)

x. On or about xxxxx, within the District of xxxxx and elsewhere, defendant xxxxx did, with the intent to defraud and mislead, introduce and cause to be introduced into interstate commerce xxxxxx (quantity) of the drug GHB, which drug was a new drug within the meaning of Title 21, United States Code, Section 321(p), and for which an approved application pursuant to Title 21, United States Code, Section 355, was not in effect with respect to such drug.

All in violation of Title 21, United States Code, Sections 331(d) and 333(a)(2), and Title 18, United States Code, Section 2.

[cited in USAM 4-8.255; Civil Resource Manual 15]