Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Registrant Actions - 2009 > Spirit Pharmaceuticals, L.L.C.; Dismissal of Proceeding

Registrant Actions - 2009

FR Doc E9-20335[Federal Register: August 24, 2009 (Volume 74, Number 162)] [Notices] [Page 42692] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24au09-93]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Spirit Pharmaceuticals, L.L.C.; Dismissal of Proceeding

On June 22, 2007, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Suspend Shipment (hereinafter, Suspension Order) to Spirit Pharmaceuticals, L.L.C. (Respondent), of Fairless Hills, Pennsylvania. Suspension Order at 1. The Order suspended Respondent's proposed importation of 2,000 kilograms of ephedrine hydrochloride from Emmellen Biotech Pharmaceuticals, Ltd., of Mumbai, India, on the ground that the product "may be diverted" to the illicit manufacture of methamphetamine, a schedule II controlled substance. Id. at 3; see also 21 U.S.C. 971(c).

The Suspension Order alleged that Respondent had identified AAA Pharmaceutical, Inc. (AAA), on its Import Declaration (DEA Form 486) as the customer for the product. Id. at 2. The Order also alleged that in a telephone conversation, a "representative of AAA stated that the ephedrine was to be manufactured into tablets, packaged, and sold to Novelty, Inc." Id. Finally, the Order alleged that Novelty, Inc., distributed over-the-counter products containing ephedrine to entities such as gas stations and convenience stores, id. at 3, that these outlets sell ephedrine products "in quantities that exceed what would be necessary to meet legitimate demand," and that the products "are often sold to persons for use in the illicit manufacture of methamphetamine." Id. at 2.

Neither Respondent nor AAA requested a hearing on the allegations.\1\ The record was then forwarded to me for final agency action.

 ---------------------------------------------------------------------------

\1\ Novelty did, however, request a hearing on the Suspension Order. On August 17, 2007, I denied Novelty's request. See 72 FR 49316 (2007).

---------------------------------------------------------------------------

On January 17, 2008, I also issued an Order to Show Cause and Immediate Suspension of Registration to Novelty.\2\ On September 3, 2008, following a hearing, I ordered the revocation of Novelty's registration as a distributor of list I chemicals and the denial of any applications it had pending before the Agency. See Novelty Distributors, Inc., 73 FR 52689, 52704 (2008).

---------------------------------------------------------------------------

\2\ Because Novelty's registration was immediately suspended, my review of the Order to Suspend Shipment was held in abeyance pending the issuance of the final order in Novelty and judicial review of it.

---------------------------------------------------------------------------

Shortly thereafter, Novelty filed a Petition for Review in the U.S. Court of Appeals for the District of Columbia Circuit. On June 22, 2009, the Court of Appeals issued a Per Curiam Order denying Novelty's Petition for Review. See Novelty, Inc., v. DEA, 2009 WL 1930184, *1 (D.C. Cir. June 22, 2009). Moreover, on July 28, 2009, the Court of Appeals denied Novelty's Petitions for Rehearing and Rehearing En Banc. See Novelty, Inc., v. DEA, No. 08-1296 (D.C. Cir. Filed July 28, 2009) (order denying rehearing and order denying rehearing en banc).

As noted above, the Suspension Order was based on Respondent's intended distribution of the ephedrine to AAA, which sought the ephedrine for the purpose of manufacturing ephedrine products for Novelty. The Court of Appeals, however, has now upheld the Agency's Final Order revoking Novelty's registration. Because Novelty lacks authority under Federal law to distribute ephedrine products, I conclude that this case is now moot. Cf. Board of License Comm'rs v. Pastore, 469 U.S. 238, 239 (1985) (per curiam). Accordingly, this proceeding is dismissed.

It is so ordered.

Dated: August 12, 2009.

Michele M. Leonhart, 
Deputy Administrator.

[FR Doc. E9-20335 Filed 8-21-09; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

Emergency Disaster Relief
National Prescription Drug Take Back Day. Turn in your unused or expired medication for safe disposal here.
RX Abuse Online

U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

DOJ Legal Policies and Disclaimers    |    DOJ Privacy Policy    |    FOIA    |    Section 508 Accessibility