Manufacturer of Controlled Substances; Notice of Registration

By Notice dated January 28, 2000, and published in the Federal Register on February 9, 2000, (65 FR 27), Mallinckrodt, Inc., Mallinckrodt & Second Streets, St. Louis, Missouri 63147, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of dihydromorphine (9145), a basic class of controlled substance listed Schedule I.

Mallinckrodt, Inc. plans to isolate dihydromorphine as a step in a multistep synthesis of hydromorphone.

DEA has considered the factors in Title 21, United States Code, Section 823(a) and determined that the registration of Mallinckrodt, Inc. to manufacture dihydromorphine is consistent with the public interest at this time. DEA has investigated Mallinckrodt, Inc. on a regular basis to ensure that the company's continued registration is consistent with the public interest. These investigations have included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823 and 28 CFR 0.100 and 0.104, the Deputy Assistant Administrator, Office of Diversion Control, hereby orders that the application submitted by the above firm for registration as a bulk manufacturer of the basic class of controlled substance listed above is granted.