Iodine is a purple to black crystalline solid with a sharp strong odor. It is used in pharmaceuticals, stains, dyes, photographic materials, antiseptics, lithography, and X-ray contrast. It is also used in the illicit manufacture of methamphetamine. As a result, iodine manufacturing and distribution is tightly controlled by the Drug Enforcement Administration (DEA).

History

On October 3, 1996 Congress passed the Comprehensive Methamphetamine Control Act of 1996 which designated iodine as a List II chemical. List II chemicals are chemicals used in the illicit manufacturing of a controlled substance. On August 1, 2007 Iodine was reclassified as a List I chemical. Like List II chemicals, List I chemicals are used in the illicit manufacturing of a controlled substance; however, List I chemicals are also considered important to the manufacturing process. List I chemicals carry more stringent regulatory requirements, including the registration of manufacturers and distributors with DEA. List I chemical iodine includes iodine crystals, pellets, and any mixture, solution, or tincture that has an iodine concentration greater than 2.2%.

In August 2007, Carolina Biological Supply Company (CBS) registered as a List I Chemical Distributor. This allows CBS to legally purchase, use, and resell regulated iodine to end user customers. It does NOT allow CBS to manufacture or export List I chemical products, and it does not allow CBS to sell or ship to resellers or other distributors.

In April 2019, CBS entered into a 3-year Memorandum of Agreement with the DEA. This agreement carries the potential for significant penalties for violating List I chemical regulations, including the termination of our List I Chemical Distributor registration. Therefore, strict compliance with all applicable regulations is critical for ensuring our continued ability to obtain, use, and sell List I chemical iodine products.

Iodine Policy

CBS has developed a comprehensive List I Chemical Iodine Policy. The policy outlines the processes and procedures that the company has implemented to ensure the security of List I chemical iodine and facilitate compliance with applicable regulations. A copy of the policy is attached.

Key Policy Points

• Iodine will only be purchased from approved, DEA-registered suppliers.
• All incoming List I chemical iodine must be received at the Rock Creek facility.
• All List I chemical Iodine will be stored securely and will only be handled by authorized employees.
• A list of all authorized employees will be maintained by the Environmental, Health, and Safety Department.
• Movement of List I chemical iodine to York Road must occur through documented stock transfers.
• CBS may use List I chemical iodine to manufacture non-regulated iodine mixtures, solutions, or tinctures.
• Manufacture of List I chemical iodine is prohibited.
• CBS sells List I chemical iodine products to domestic educational end user customers.
• CBS may sell List I chemical iodine to approved domestic business end user customers on a case by case basis
• CBS will not sell to List I chemical iodine products to international customers and will not offer List I chemical iodine products for export.
• CBS will not sell or ship List I chemical iodine products to a reseller or distributor.
• Except for educational products specifically intended for home-based instruction, CBS will not sell List I chemical iodine to individuals or ship List I chemical iodine to residential addresses.
• All List I chemical iodine products are included in CBS’s “Regulated Chemical (08)” list and the International Sales Department’s “Do Not Export” list.
• List I Chemical iodine products will have appropriate item comments in JD Edwards including “No International Shipments.”
• All orders that include one or more List I Chemical iodine products will be placed on automatic (08) hold.
• All orders that include one or more List I Chemical iodine products will be reviewed by the EHS Department prior to release.
• List I chemical iodine products will be physically counted on a monthly basis and the results will be compared to the perpetual inventory shown in JD Edwards. Any discrepancies will be immediately investigated.

List I Chemical Iodine Products

The following CBS products contain List I chemical Iodine in regulated concentrations and are therefore subject to the applicable requirements of 21 CFR Chapter II Drug Enforcement Administration, Department of Justice. It is imperative that this list remains current and up-to-date. If new products are added, bills of materials change, or if you otherwise become aware of any product containing greater than 2.2% iodine that is not included on this list, please notify the EHS Department immediately.

• 122205 IHUB Ecosystems Unit Bundle
• 581084 MCC Chem 1010 Kit (Discontinued)
• 699854 Chemistry of Fuming for Fingerprints Kit
• 840576 AP Chem Bonding Types Kit
• 840576A AP Chem Bonding Types Kit
• 868972 Iodine LG, 100g
• 868982 Iodine RG, 25g
• 868984 Iodine RG, 100g
• 868990 Iodine RG, 500g (Discontinued)
• 872793 Lugols Solution, 100mL
• 872795 Lugols Solution, 500mL
• 872797 Lugols Solution, 1L
• C70185, Iodine, Prilled, 30lb
• C72082 0.5 Iodine, LG (Discontinued)