DEA Publishes Interim Final Rule for Mail-Order Distributors of Scheduled Listed Chemical ProductsApril 17, 2011
On Wednesday, April 13, 2011, the Drug Enforcement Administration (“DEA”) published an Interim Final Rule with a request for comments on the “Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products.” See 76 Fed. Reg. 20,518 (Apr. 13, 2011). The Interim Rule implements the Combat Methamphetamine Enhancement Act of 2010 (“CMEA”), which President Obama signed into law on October 12, 2010, and we blogged about here.
Although retail distributors of these products have been subject to self certification and training requirements since 2006, the 2010 law establishes new requirements for mail-order distributors of scheduled listed chemical products (“SLCPs”), which are defined in the Controlled Substances Act (“CSA”) as products containing ephedrine, pseudoephedrine or phenylpropanolamine, and are marketed in the United States as non-prescription drugs, see 21 U.S.C. § 802(45).
The new federal law requires mail-order distributors to self-certify to DEA in order sell SLCPs at retail if those retail sales are intended for personal use. The DEA defines a “mail-order distributor” as a person who makes sales at retail of SLCPs for personal use, and uses the U.S. postal service or a private or commercial carrier to deliver the product to the customer. The mail-order distributor’s required self-certification must include a statement that the distributor understands the regulatory requirements, and that its employees will receive the appropriate training prior to self-certification.
After April 10, 2011, which is the date of the implementation of the CMEA, a mail-order distributor cannot sell SLCPs at retail unless it has self-certified through DEA’s website (and paid a $21.00 fee). The self-certification requires the distributor to confirm the following: (1) The distributor understands that under federal law it can sell no more than 3.6 grams of SLCPs per day, or 7.5 grams in a thirty-day period, to each customer (versus a 9 gram monthly limit for face-to face sales); (2) the distributor’s employees have undergone DEA-required training prior to self-certification; and (3) the distributor is maintaining employee training records. The distributor must submit a self-certification for each place of business where it sells the products at retail, which, for a mail-order distributor means, “at each location that prepares or packages products for distribution to customers, and each location where employees accept payment for such sales.” Id. at 20,520. The interim rule sets forth (in table form) a summary of requirements for mail-order sellers of SCLPs now in effect since the enactment of the CMEA. Id. at 20,521
The required content of the employee training has been developed by DEA and is available at its website, (http://www.deadiversion.usdoj.gov). DEA states that employers “must use the content of this training in the training of their employees” who sell SLCPs. An employer may supplement the required DEA training with its own content as well. Id. at 20,520. Starting on or after April 10, 2011, each employee of a mail order distributor who is responsible for delivering SLCPs directly to purchasers, or “who deals directly with purchasers by obtaining payment for the [SLCPs]” must undergo the training, and must sign an acknowledgement that he or she has received training prior to selling SLCPs. The record must also be kept in the employee’s personnel file.
The interim rule implementing the law further provides that when a mail-order distributor files its initial self-certification, the DEA will assign it to one of twelve groups. The expiration date of the self-certification for all regulated persons within any one group will be “the last day of the month designated for that group.” The first certification period will run for a period of not less than 12 to not more than 23 months from the date of self-certification. After this initial certification period expires, distributors must update their regulated persons must update their self-certification on an annual basis. Id. at 20,521.
The interim rule’s preamble notes that “a mail-order distributor that knowingly or willfully self-certifies to facts that are not true is subject to fines and imprisonment by virtue of 18 U.S.C. § 1001.” Id. 20,520. In addition, it is unlawful for mail-order distributors to “negligently fail to self-certify” under 21 U.S.C. § 830 (by an amendment to 21 U.S.C. § 842(a)(10)).
The interim rule is effective April 13, 2011. Note, however, that the law requiring self-certification became effective on April 10, 2011 (180 days after its enactment on October 10, 2010). DEA is soliciting comments on the interim rule, due on June 13, 2011. The DEA found “good cause” to exempt this rule from notice and comment rulemaking that is normally required under the Administrative Procedure Act, because DEA asserts that the “requirements addressed by the [CMEA] in this rulemaking are self-implementing and changes in this rulemaking provide conforming amendments to make the language of the regulations consistent with that of the law.” Id. at 20,519.