CHAPTER § 2.05 Listed-Chemical Regulatory Requirements

• Jurisdiction: United States

§ 2.05 Listed-Chemical Regulatory Requirements

In many respects, the regulatory requirements applicable to listed chemicals parallel the requirements governing controlled substances. In the interest of concision, this section merely summarizes the applicable requirements and notes certain differences between the two regimes.⁹¹

[1] Registration

A person who distributes, imports, exports, or manufactures for distribution or export a List I chemical must register with DEA. Certain exceptions exist: for example, controlled-substance registrants that handle List I chemicals typically need not obtain separate registration for activities covered by the controlled-substance registration.⁹² In addition, firms that manufacture List I chemicals for internal consumption only and do not further distribute or export them need not register. Retail distributors of ordinary over-the-counter drug products that include some combination of ephedrine, pseudoephedrine, and/or phenylpropanolamine are exempt from registration under specified circumstances.⁹³ (Note, however, that exemption from registration does not eliminate the application of other regulatory requirements, such as security controls and record-keeping, discussed below.⁹⁴)

As is the case with controlled substances, multiple, location-specific registrations are typically required for manufacturers handling List I chemicals at separate sites.⁹⁵ The nature of business activities is relevant, as well. The following groups of activities are considered independent and may necessitate distinct registrations: retail distribution of drug products that contain List I chemicals; non-retail distribution of List I chemicals; importing List I chemicals; and exporting List I chemicals.⁹⁶

[2] Physical and Other Security Controls

Registrants must provide effective controls against the theft or diversion of List I chemicals. Common controls include: the use of tamper-evident containers and/or controlled access storage; employee-background checks; and behind-the-counter storage in retail settings.⁹⁷

Whether or not one is required to register, any "regulated person" engaging in a "regulated transaction" must: identify the other party to the transaction; verify the existence and apparent validity of a business entity placing the order; and maintain customer files. The term "regulated person" is broader than the category of "registrants" and means "a person who manufactures, distributes, imports, or exports a listed chemical, a...