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United States v. Cantrell Drug Co.

United States District Court, E.D. Arkansas, Little Rock Division

April 19, 2018

UNITED STATES OF AMERICA, Plaintiff,
v.
CANTRELL DRUG COMPANY, a corporation, and JAMES L. McCARLEY, JR., an individual, Defendants.

          For Defendants JAMES L. McCARLEY, JR. Individually and on behalf of CANTRELL DRUG COMPANY

          S. GRAHAM CATLETT Attorney for Defendants

          For Plaintiff CODY HILAND United States Attorney Eastern District of Arkansas GUSTAV EYLER Acting Director Consumer Protection Branch RAQUEL TOLEDO Trial Attorney Consumer Protection Branch Department of Justice, Civil Division OF COUNSEL: ROBERT P. CHARROW General Counsel REBECCA K. WOOD Chief Counsel Food and Drug Division ANNAMARIE KEMPIC Deputy Chief Counsel for Litigation JENNIFER KANG Associate Chief Counsel Office of the Chief Counsel Food and Drug Administration

          ORDER

         Plaintiff, the United States of America, by its undersigned attorneys, having filed a Complaint for Injunction against Cantrell Drug Company ("Cantrell"), a for-profit corporation, and James L. McCarley, Jr., an individual (collectively, "Defendants"), and Defendants having appeared and having consented to the entry of this Consent Decree of Permanent Injunction ("Decree") without contest, without admitting or denying the allegations in the complaint, and before any testimony has been taken, and the United States of America having consented to this Decree; IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:

         1. This Court has jurisdiction over the subject matter and all parties to this action under 28 U.S.C. §§1331 and 1345, and 21 U.S.C. § 332, and its inherent equitable authority.

         2. The Complaint for Injunction states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 etseq. (the "Act").

         3. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or causing to be introduced, or delivering or causing to be delivered for introduction, into interstate commerce, articles of drug that are adulterated within the meaning of 21 U.S.C. § 351(a)(2)(A), in that the drugs have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health.

         4. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or causing to be introduced, or delivering or causing to be delivered for introduction, into interstate commerce, articles of drug that are adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, labeling, holding, and/or distributing do not conform to, or are not operated or administered in conformity with, current good manufacturing practice to assure that such drugs meet the requirements of the Act as to safety and have the identity and strength, and meet the quality and purity characteristics, which they purport or are represented to possess.

         5. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of drug to become adulterated within the meaning of 21 U.S.C. §§ 351(a)(2)(A) and 351(a)(2)(B), while the drugs are held for sale after shipment of one or more of their components in interstate commerce.

         6. For the purposes of this Decree, the following definitions shall apply:

A. “Bulk drug substance” shall mean any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances;
B. “CGMP” shall refer to the current good manufacturing practice requirements for drugs within the meaning of 21 U.S.C. § 351(a)(2)(B). See 21 C.F.R. Parts 210 and 211. In determining whether Defendants are compounding drugs at an outsourcing facility in compliance with CGMP, Defendants, their expert consultants, and FDA may consider any regulations and/or guidance that FDA has issued with respect to CGMP for outsourcing facilities;
C. “Compound” and “compounding” shall include the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug;
D. The terms “manufacture, ” “manufactured, ” and “manufacturing” shall include manufacturing, compounding, processing, packing, repacking, labeling, and holding drugs;
E. “Distribution” and “distributing” shall mean to sell, trade, ship, or deliver and shall include, but not be limited to, delivery or shipment to a healthcare setting for administration and dispensing to a patient or to an agent of a patient;
F. “Drug” shall have the meaning given the term in 21 U.S.C. § 321(g)(1);
G. “Drug product” shall mean a finished dosage form (for example, tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients;
H. “Sterile drug” shall have the meaning as set out in 21 U.S.C. § 353b(d)(5);
I. “Days” shall refer to calendar days unless otherwise stated;
J. “FDA” shall mean the United States Food and Drug Administration; and
K. “Defendants' facility” shall refer to the facility located at 7321 Cantrell Road, Little Rock, Arkansas, 72207, and any other location(s) (including any new locations) at or from which, at any time in the future, any Defendant, directly or indirectly, manufactures, processes, packs, labels, holds, and/or distributes drugs, whether or not any Defendant has an ownership interest in the business.

         7. On December 16, 2013, Defendants' facility located at 7321 Cantrell Road, Little Rock, Arkansas, 72207, registered with FDA as an outsourcing facility pursuant to 21 U.S.C. § 353b. Cantrell re-registered as an outsourcing facility pursuant to 21 U.S.C. § 353b most recently on December 19, 2017.

         8. Upon entry of this Decree, Defendants and each and all of their directors, officers, agents, employees, representatives, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them who have received actual notice of this Decree by personal service or otherwise, are permanently restrained and enjoined, under 21 U.S.C. § 332(a) and the inherent equitable authority of this Court, from directly or indirectly manufacturing, processing, packing, labeling, holding, and/or distributing any drugs manufactured at and/or from Defendants' facility, unless and until:

         A. Defendants ensure that the facilities, methods, and controls used to manufacture, process, pack, label, hold, and/or distribute drugs are established, operated, and administered in conformity with this Decree, the Act, and its implementing regulations, and are adequate to prevent Defendants' drugs from becoming adulterated within the meaning of 21 U.S.C. §§ 351(a)(2)(A) and 351(a)(2)(B); B. Defendants ensure that each and every drug that Defendants intend to manufacture, process, pack, label, hold, and/or distribute at or from their facility satisfies all of the provisions of 21 U.S.C. § 353b, including but not limited to:

(1) Drug labeling at 21 U.S.C. § 353b(a)(10);
(2) Facility registration at 21 U.S.C. § 353b(b)(1);
(3) Use of bulk drug substances at 21 U.S.C. § 353b(a)(2);
(4) Drug reporting at 21 U.S.C. § 353b(b)(2);
(5) Adverse event reporting at 21 U.S.C. ยง ...

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