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    • 5th Ed. Vol. 1 Chpt. 1
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Home > Drugs & Pharmaceutical Products
Published December 22, 2011 by Yuri Starikov

DEA’s Office of Diversion Control Role in International Trade

Office of Diversion Control regulates the export of controlled substances and precursor chemicals.  All controlled substances and precursor chemicals are divided into 5 categories, called schedules. Regardless of category, permit or declaration are required upon export or import. The only time when neither permit, nor declaration are required, is when the substance is either exempt from the list or is not a part of the list. Only those persons registered with and authorized by DEA to import or export controlled substances may utilize/submit declarations and applications for permits. Controlled Substances Import-Export Form Guide Controlled Substances Act Schedule DEA-161 DEA-357 DEA-236 Import Export Schedule I X X Schedule II X X Schedule III Narcotic X X Schedule III Nonnarcotic (except for delta-9-THC which requires a permit) X X Schedule IV Narcotic X X Schedule IV Nonnarcotic X X Schedule V Narcotic X X Schedule V Nonnarcotic X X

Read More DEA’s Office of Diversion Control Role in International Trade

Product Regulation U.S. Federal Agencies

Chemical Products Drugs & Pharmaceutical Products Office of Diversion Control

Published December 11, 2011 by Yuri Starikov

Nitroglycerin Jurisdictional Journey

Nitroglycerin (in medicinal form) is currently listed on the Alphabetical Index to the Commerce Control List for 1C992.l.  However, if one checks CCL, one will find the following: “Other commercial explosive devices and charges not controlled by 1C992.a through .k containing less than or equal to 1.0 kg of controlled materials.”  No mention of medicinal nitroglycerin.  Why not? Pursuant to 67 FR 70839, public notice 4209, Office of Defense Trade Controls removes nitroglycerin from USML and transfers control to the Commerce Department. In 2006, nitroglycerin was also removed from CCL and transferred to alphabetical index.

Read More Nitroglycerin Jurisdictional Journey

Product Regulation U.S. Federal Agencies

Bureau of Industry and Security Directorate of Defense Trade Controls Drugs & Pharmaceutical Products ECCN 1C992

Published December 7, 2011 by Yuri Starikov

Product Compliance Requirements under Poison Prevention Packaging Act

Consumer Product Safety Commission (CPSC) administers Poison Prevention Packaging Act pursuant to 15 U.S.C. §§ 1471-1476, 16 CFR Subchapter E; §§ 1700 – 1702. CPSC, broadly speaking, provides regulation standards for the special packaging of any household substance that the Commission finds pose degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance. If the product fits the scope above, then the importer and/or the person placing the product in the United States commerce is subject to certain labeling and packaging requirements.  Specifically, the statement “This Package for Households Without Young Children” shall appear conspicuously on the package of any household substance subject to the special packaging requirements that is supplied in noncomplying packaging, unless the package bears the substitute labeling statement (see Sec. 1700.5(a) for details).  Substitute statement “Package Not Child-Resistant” may be used (see Sec. 1700.5(b) for details).  Also, the packaging must conform to the requirements under Sec. 1700.15.

Read More Product Compliance Requirements under Poison Prevention Packaging Act

Product Regulation U.S. Federal Agencies

Consumer Product Safety Commission Drugs & Pharmaceutical Products Home & Garden Products Packaging & Shipping Products Poison Prevention Packaging Act

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