SUMMARY: In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005, which establishes new requirements for retail sales of over-the-counter (nonprescription) products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The three chemicals can be used to manufacture methamphetamine illegally. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements. This action establishes daily and 30-day limits on the sales of scheduled listed chemical products to individuals and requires recordkeeping on most sales.
DATES: Effective Dates: September 21, 2006, except that Sec. Sec. 1314.20, 1314.25, and 1314.30 (with the exception of Sec. 1314.30(a)(2)) are effective September 30, 2006. Section 1314.30(a)(2) is effective November 27, 2006.
Comment Date: Written comments must be postmarked on or before November 27, 2006.
ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-291I" on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson- Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to firstname.lastname@example.org. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov website. DEA will accept attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537; telephone: (202) 307-7297.
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801- 971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes and to deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA as amended also requires DEA to regulate the manufacture and distribution of chemicals that may be used to manufacture controlled substances illegally. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances. On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). DEA is promulgating this rule as an interim final rule rather than a proposed rule because the changes being made codify statutory provisions, some of which are already in effect. Parts of the statute are self- implementing; certain changes related to retail sales became effective upon signature (March 9, 2006), others
became effective on April 8, 2006, and still others will become effective September 30, 2006. An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest. Many of the requirements of the Combat Methamphetamine Epidemic Act of 2005 included in this rulemaking were set out in such detail as to be self- implementing. Therefore the changes in this rulemaking provide conforming amendments to make the language of the regulations consistent with that of the law. DEA is accepting comments on other aspects of this rulemaking, particularly those not specifically mandated by the Combat Methamphetamine Epidemic Act of 2005.
Combat Methamphetamine Epidemic Act of 2005
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) amends the CSA to change the regulations for selling nonprescription products that contain ephedrine, pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, and salts of optical isomers. CMEA creates a new category of products called "scheduled listed chemical products." Ephedrine, pseudoephedrine, and phenylpropanolamine are List I chemicals because they are used in, and important to, the illegal manufacture of methamphetamine. Products containing these List I chemicals also have legitimate medical uses. Ephedrine is used in some products for treating asthma. Pseudoephedrine, a decongestant, is a common ingredient in cold and allergy medications. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory concerning phenylpropanolamine and requested that all drug companies discontinue marketing products containing phenylpropanolamine due to risk of hemorrhagic stroke. In response, many companies voluntarily reformulated their products to exclude phenylpropanolamine. Subsequently, on December 22, 2005, FDA published a Notice of Proposed Rulemaking (70 FR 75988) proposing to categorize all over-the-counter nasal decongestants and weight control drug products containing phenylpropanolamine preparations as Category II, nonmonograph, i.e., not generally recognized as being safe for human consumption. Most products containing phenylpropanolamine intended for humans have been withdrawn from the market, but phenylpropanolamine is still sold by prescription for veterinary uses.
Under previous CSA amendments (the Comprehensive Methamphetamine Control Act of 1996 (MCA) and the Methamphetamine Anti-Proliferation Act of 2000 (MAPA)), Congress limited the quantity of products containing ephedrine, pseudoephedrine, and phenylpropanolamine that could be sold as nonprescription drugs at retail (which were, along with certain liquid products, defined as "ordinary over-the-counter pseudoephedrine or phenylpropanolamine products") without recordkeeping, but generally exempted products sold in blister packs sold by "retail distributors". The MCA established thresholds for these drug products, including a threshold of 24 grams of combination ephedrine products; single-entity ephedrine products had been regulated by the Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103- 200). MAPA reduced existing thresholds for pseudoephedrine and phenylpropanolamine to 9 grams per transaction, with each package containing not more than 3 grams of pseudoephedrine base or phenylpropanolamine base, but retained the so-called "blister pack" exemption. Because most retail outlets did not want to create and maintain records of sales or register as a retail distributor, the threshold for recordkeeping functioned for practical purposes similarly to a sales limit. Much of the product was also sold in blister packs.
Congress determined that the existing limits were not sufficient to prevent people from buying these products and using them to illegally manufacture methamphetamine. In the Combat Methamphetamine Epidemic Act of 2005, Congress adopted provisions that do the following:
- Limit the quantity of each of the chemicals that may be sold to an individual in a day to 3.6 grams of the chemical, without regard to the number of transactions.
- For nonliquids, limit packaging to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches.
- Require regulated sellers to place the products behind the counter or in locked cabinets.
- Require regulated sellers to check the identity of purchasers and maintain a log of each sale that includes the purchaser's name and address, signature of the purchaser, product sold, quantity sold, date, and time.
- Require regulated sellers to maintain the logbook for at least two years.
- Require regulated sellers to train employees in the requirements of the law and certify to DEA that the training has occurred.
- For mobile retail vendors and mail order sales, require sellers to limit sales to an individual in a 30-day period to 7.5 grams.
- For individuals, limit purchases in a 30-day period to 9 grams, of which not more than 7.5 grams may be imported by means of a common or contract carrier or the U.S. Postal Service.
The numbers of dosage units and milliliters (mL) that may be purchased under the sales limits are shown in Table 1 below. As noted previously, the FDA issued a voluntary recall on phenylpropanolamine products as being unsafe for humans so no phenylpropanolamine over-the- counter (OTC) product should be available for human consumption. Veterinary use is by prescription only.
Table 1.--Number of Tablets/Milliliters That Equal Retail Transaction Limits (as Base) for Scheduled Listed Chemical Products
|Scheduled listed chemical product||Transaction limits|
|3.6 gm||7.5 gm||9.0 gm|
|25 mg Ephedrine HCI||175||366||439|
|25 mg Ephedrine Sulfate||186||389||466|
|Pseudoephedrine (as HCI):|
|30 mg Pseudoephedrine HCI||146||305||366|
|60 mg Pseudoephedrine HCI||73||152||183|
|120 mg Pseudoephedrine HCI||36||76||91|
|Pseudoephedrine (as Sulfate):|
|30 mg Pseudoephedrine Sulfate||155||324||389|
|60 mg Pseudoephedrine Sulfate||77||162||194|
|120 mg Pseudoephedrine Sulfate||38||81||97|
|240 mg Pseudoephedrine Sulfate||19||40||48|
|Number of mL|
|6.25 mg/5 ml Ephedrine HCI||3,515||7,323||8,788|
|Pseudoephedrine (as HCI):|
|15 mg/1.6 mL Pseudoephedrine HCI||468||976||1,171|
|7.5 mg/5 mL Pseudoephedrine HCI||2,929||6,103||7,323|
|15 mg/5 mL Pseudoephedrine HCI||1,464||3,051||3,661|
|15 mg/2.5 mL Pseudoephedrine HCI||732||1,525||1,830|
|30 mg/5 mL Pseudoephedrine HCI||732||1,525||1,830|
|30 mg/2.5 mL Pseudoephedrine HCI||366||762||915|
|60 mg/5 mL Pseudoephedrine HCI||366||762||915|
Provisions of CMEA
Overview. Before CMEA, requirements for sales of products containing ephedrine, pseudoephedrine, and phenylpropanolamine, which were then called regulated drug products or drug products regulated pursuant to 21 CFR 1300.02(b)(28)(i)(D), distinguished between in- person sales to a purchaser (retail distribution) and mail order sales, which covered any sale where the product is shipped using the Postal Service or any common or private carrier. Mail order sellers had to file monthly reports with DEA if they sold a purchaser drug products containing more than a threshold quantity (9 grams for pseudoephedrine and phenylpropanolamine (maximum per package of 3 grams), 24 grams for ephedrine combination products), regardless of how the products were packaged. Retailers conducting face-to-face transactions had to maintain records for sales above the same thresholds except that, as noted above, sales of products in blister packs generally were not covered. The status of such sales was discussed in detail in an interpretive rule (69 FR 2862, January 14, 2004; corrected at 69 FR 3198, January 22, 2004). Either type of seller had to register with DEA if they sold the products to individuals in amounts above the threshold quantity. Only two persons are registered as retail distributors.
The CMEA provisions on retail sales create differing requirements for the various types of retail sales. As discussed further below, Table 2 summarizes the applicability of the CMEA provisions as well as existing DEA provisions to the different types of sellers.
Table 2.--Summary of Requirements by Type of Seller
|Mail order sellers|
|Daily sales limit||3.6 gm/chemical||3.6 gm/chemical||3.6 gm/chemical|
|30 day sales limit||7.5 gm||7.5 gm|
|Storage||Behind the counter
|Customer ID||Examine photo ID||Examine photo ID||Verify ID|
|Notice of misrepresentation||Yes||Yes||NA|
|Theft and loss reports||Yes||Yes||Yes|
CMEA defines nonprescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine as "scheduled listed chemical products." Direct, in-person sales to a customer, whether at a permanent store or movable site (e.g., kiosk, flea market), are subject to new requirements for training of employees who take part in the sale of scheduled listed chemical products and certification to DEA that the employees have been trained. These sellers, called "regulated sellers" in CMEA, must also check photo identifications of purchasers and maintain specific records of each sale of scheduled listed chemical products. Under CMEA, the
only sales exempt from recordkeeping are sales of single packages of pseudoephedrine where the package contains not more than 60 milligrams. DEA will issue future guidance to further clarify remaining questions about how regulated entities may meet this regulation's training requirements.
The recordkeeping and reporting requirements for mail order sales basically remain the same as under the previous regulations, except that a waiver in the prior law that covered non face-to-face distributions by retail distributors has been eliminated for scheduled listed chemical products. As a result, retail stores that deliver these products to customers by mail or delivery services will need to comply with the provisions for mail order sales reporting for these transactions. Mail order sellers must file monthly reports with DEA. CMEA adds the requirement that these sellers verify the purchaser's identity prior to shipping.
As noted above, CMEA changes the limits on retail sales. Daily sales are now limited to a maximum of 3.6 grams of each chemical in scheduled listed chemical products. Mobile retail vendors and mail order vendors must also limit sales to an individual purchaser to 7.5 grams of each chemical in scheduled listed chemical products in any 30- day period. CMEA limits purchases by an individual purchaser to 9 grams of each chemical in scheduled listed chemical products in any 30-day period, not more than 7.5 grams of which may be imported by means of a private or commercial carrier or the U.S. Postal Service. Any imports of scheduled listed chemical products subject to the 7.5 gram purchase limit under CMEA must also otherwise comply with all other applicable Federal and State laws regarding their importation, including the Federal, Food, Drug, and Cosmetic Act. This provision is not included in this rule, but will be addressed in other rulemakings DEA is promulgating to implement the various provisions of the Combat Methamphetamine Epidemic Act of 2005. Finally, CMEA exempts all retail sellers and mail order distributors selling the products at retail from registration. The following sections discuss each of the statutory provisions in more detail.
Definitions. CMEA revises the definition of "regulated transaction," adds several new definitions, and removes the definition of "ordinary over-the-counter pseudoephedrine or phenylpropanolamine product." CMEA adds a definition of "scheduled listed chemical product," which means any nonprescription product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and is marketed lawfully under the Federal Food, Drug, and Cosmetic Act. References to ephedrine, pseudoephedrine, or phenylpropanolamine include their salts, optical isomers, and salts of optical isomers. CMEA exempts scheduled listed chemical products sold at retail by a regulated seller or by persons that sell the product for personal use and ship the product by mail or private or common carriers (mail order sellers) from the definition of regulated transaction. It also removes other references to the sale of these chemicals in drug products from the definition of regulated transactions. DEA notes that further clarification regarding regulated transactions will be addressed in a separate rulemaking. These changes remove retail sellers and mail order sellers from the registration system; in practice, retail and mail order sellers have not registered because they limited sales to below threshold quantities and to products sold in blister packs. At present, only two persons are registered as retail distributors.
CMEA adds definitions of "regulated seller," to mean a retail distributor (including a pharmacy and mobile retail vendors), and "at retail," to mean sale or purchase for personal use. It also revises the definition of "retail distributor" to remove the sentence referring to below threshold quantities. This change subjects all sales, except for sales of single packages containing not more than 60 milligrams of pseudoephedrine, to recordkeeping requirements.
Sales limits. Effective April 8, 2006, CMEA limits sales to an individual to 3.6 grams per day of each chemical in scheduled listed chemical products regardless of the number of purchases. Mobile retail vendors and mail order sellers may not sell an individual more than 7.5 grams of each chemical in scheduled listed chemical products in a 30- day period. A seller who violates these provisions is subject to civil penalties and possible criminal penalties.
Purchase limits. CMEA imposes a 9 gram purchase limit in a 30-day period on individuals. Not more than 7.5 grams of the 9 grams may be imported by means of common/contract carrier or the U.S. Postal Service. Any imports of scheduled listed chemical products subject to the 7.5 gram purchase limit under CMEA must also otherwise comply with all other applicable Federal and State laws regarding their importation, including the Federal, Food, Drug, and Cosmetic Act. This provision is not included in this rule, but will be addressed in other rulemakings DEA is promulgating to implement the various provisions of the Combat Methamphetamine Epidemic Act of 2005. In other rulemakings based on new CMEA provisions, imports, other than this 30-day individual limit, are limited to DEA registrants that have been issued a quota to import. (These rulemakings will be separately published in the Federal Register.) A purchaser who violates these limits is subject to criminal penalties.
Thirty-day limit. CMEA creates a 30-day sales limit. DEA interprets this to mean a rolling calendar where the sales limit is based on sales to the purchaser in the previous 30 days. DEA interprets the per day limit to refer to midnight to midnight, not a rolling 24-hour clock.
Blister packs. Effective April 8, 2006, nonliquid forms of scheduled listed chemical products (including gel capsules) must be sold only in blister packs, with no more than two dosage units per blister unless blister packs are technically infeasible. In that case, the dosage units must be in unit dose packets or pouches.
Product placement: Behind counter or locked cabinet. CMEA requires that on and after September 30, 2006, scheduled listed chemical products must be stored behind the counter or, if in an area where the public has access, in a locked cabinet. Although DEA is not including cabinet specifications in the rule, a locked cabinet should be substantial enough that it cannot be easily picked up and removed. In a store setting, the cabinet should be similar to those used to store items, such as cigarettes, that can be accessed only by sales staff.
Logbooks. CMEA requires retail sellers to maintain logbooks on and after September 30, 2006. If a retailer maintains the logbook on paper, DEA is requiring that the logbook be bound, as is currently the case for records of sales of Schedule V controlled substances that are sold without a prescription. Bound blank logbooks and ledger books meeting DEA's regulatory requirements are readily available on the commercial market. If the logbook is maintained electronically, the records must be readily retrievable by the seller and any DEA or other authorized law enforcement official. Logs must be kept for two years from the date the entry was made. The logs must include the information entered by the purchaser (name, address, signature, date, and time of sale) and the quantity and form of the product sold.
Where the record is entered electronically, the computer system may enter the date and time automatically. An electronic signature system, such as the ones many stores use for credit card purchases, may be employed to capture the signature for electronic logs. The information that the seller must enter may be accomplished through a point-of-sales system and bar code reader.
DEA is aware that in some cases, such as pharmacy counters where the computer is behind the pharmacy counter, it may be difficult for the purchaser to enter the information electronically. DEA is seeking comments on whether systems currently used to capture signatures for credit or debit card purchases can be reprogrammed to allow customers to enter name and address, as well as the signature. DEA also recognizes that some purchasers will find it difficult or impossible to enter the information themselves. In these cases, the seller should ask for the name and address and enter it, rather than simply copy it off the photo ID. Regardless of how the information is entered, however, there must be a mechanism to allow the customer to sign the logbook.
Verification of photo ID. CMEA requires on and after September 30, 2006, that an individual must present an identification card that includes a photograph and is issued by a State or the Federal government or a document considered acceptable under 8 CFR 274a.2(b)(1)(v)(A) and (B). Those documents currently include the following:
- United States passport (unexpired or expired).
- Alien Registration Receipt Card or Permanent Resident Card, Form I-551.
- An unexpired foreign passport that contains a temporary I- 551 stamp.
- An unexpired Employment Authorization Document issued by the Immigration And Naturalization Service which contains a photograph, Form I-766; Form I-688, Form I-688A, or Form I-688B.
- In the case of a nonimmigrant alien authorized to work for a specific employer incident to status, an unexpired foreign passport with an Arrival-Departure Record, Form I-94, bearing the same name as the passport and containing an endorsement of the alien's nonimmigrant status, so long as the period of endorsement has not yet expired and the proposed employment is not in conflict with any restrictions or limitations identified on the Form I-94.
For individuals 16 years of age or older:
- A driver's license or identification card containing a photograph, issued by a State or an outlying possession of the United States. If the driver's license or identification card does not contain a photograph, identifying information shall be included such as: Name, date of birth, sex, height, color of eyes, and address.
- School identification card with a photograph.
- Voter's registration card.
- U.S. military card or draft record.
- Identification card issued by Federal, State, or local government agencies or entities. If the identification card does not contain a photograph, identifying information shall be included such as: Name, date of birth, sex, height, color of eyes, and address.
- Military dependent's identification card.
- Native American tribal documents.
- United States Coast Guard Merchant Mariner Card.
- Driver's license issued by a Canadian government authority.
For individuals under age 18 who are unable to produce a document from the list above of acceptable documents for persons age 16 years and older:
- School record or report card.
- Clinic doctor or hospital record.
- Daycare or nursery school record.
The list of acceptable forms of identification, as cited in CMEA, may change ("in effect on or after the date of enactment"). DEA has no discretion to alter the list.
Notice on misrepresentations. CMEA requires that on and after September 30, 2006, the logbooks include a notice to purchasers that entering false statements or misrepresentations may subject the purchaser to criminal penalties under section 1001 of title 18 of the U.S. Code. DEA is requiring the inclusion of the following language in all logbooks:
Warning: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both.
With both a bound logbook and electronic log, inclusion of this notice may present difficulties. If the purchaser is not able to enter the information electronically in a store, providing the notice electronically will not meet the requirements. If not feasible in these situations, one alternative is that the seller prominently display the notice where the purchaser will see it when entering or providing the information.
Verification of identity for mail order sales. The Controlled Substances Act (21 U.S.C. Sec. 830(b)(3)) requires that each regulated person, as defined in the Act, who engages in a transaction that involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals) and uses or attempts to use the Postal Service or any private or commercial carrier shall, on a monthly basis, submit a report of each transaction conducted during the previous month to DEA. Data contained in the report includes, but is not limited to: Name of purchaser; quantity and form of ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent. DEA has specified further information regarding mail order reports by regulation (21 CFR 1310.05).
CMEA requires that effective April 8, 2006, the mail order seller confirm the identity of the purchaser prior to shipping the product. CMEA requires DEA to establish procedures for this identity verification by regulation. To parallel the identification requirements for regulated sellers, and to provide reasonable assurance that the person purchasing the product is who they claim to be, DEA is requiring that mail order sellers verify the identity of the purchaser by obtaining a copy of an identification card that includes a photograph and is issued by a State or the Federal government or a document considered acceptable under 8 CFR 274a.2(b)(1)(v)(A) and (B). Such a copy may be obtained through use of the Postal Service, facsimile transmission of a photocopy, or the scanning and transmission of the identification card, among other examples. The mail order seller must determine that the name and address on the identification card correspond to the name and address provided to the mail order seller as part of the sales transaction. If the information cannot be confirmed, the seller may not ship the items.
Selling at retail. CMEA requires that on and after September 30, 2006, a regulated seller must not sell scheduled listed chemical products unless it has self-certified to DEA, through DEA's website. The self-certification requires the regulated seller to confirm the following:
- Its employees who will be engaged in the sale of scheduled listed chemical products have undergone training regarding provisions of CMEA.
- Records of the training are maintained.
- Sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine per day. (Mobile
retail vendors must also confirm that sales to an individual in a 30- day period do not exceed 7.5 grams.)
- Nonliquid forms are packaged as required.
- Scheduled listed chemical products are stored behind the counter or in a locked cabinet.
- A written or electronic logbook containing the required information on sales of these products is properly maintained.
- The logbook information will be disclosed only to Federal, State, or local law enforcement and only to ensure compliance with Title 21 of the United States Code or to facilitate a product recall.
The seller must train its employees and self-certify before either the seller or individual employees may sell scheduled listed chemical products. The self-certification is subject to the provisions of 18 U.S.C. 1001. A regulated seller who knowingly or willfully self- certifies to facts that are not true is subject to fines and imprisonment.
Training. DEA has developed training that it has made available on its website (http://www.deadiversion.usdoj.gov). Employers must use the content of this training in the training of their employees who sell scheduled listed chemical products. An employer may include additional content to DEA's, but DEA's content must be included in the training. For example, a regulated seller may elect to incorporate DEA's content into initial training for new employees.
Training records. On and after September 30, 2006, each employee of a regulated seller who is responsible for delivering scheduled listed chemical products to purchasers or who deals directly with purchasers by obtaining payment for the scheduled listed chemical products must undergo training and must sign an acknowledgement of training received prior to selling scheduled listed chemical products. This record must be kept in the employee's personnel file.
Self-certification. On and after September 30, 2006, the regulated seller must self-certify to DEA as described above. DEA has established a Web page that will allow regulated sellers to complete the self- certification online and submit it to DEA electronically. A self- certification certificate will be generated by DEA upon receipt of the application. The regulated seller will print this self-certification certificate, or if the regulated seller is unable to print it, DEA will print and mail the certificate to the self-certifier. The regulated sellers will be classified into three categories: Chain stores that are currently controlled substance registrants, chain stores that are not registrants, and individual outlets. Chain stores wishing to file self- certifications for more than 10 locations will have to print or copy the form electronically and submit the information to DEA by mail. DEA will work with these persons to facilitate this process. Persons interested in this self-certification option should contact DEA for assistance. For current DEA registrants, the system will pre-populate the form with basic information.
Because CMEA specifically states that a separate self-certification is required for each separate location at which scheduled listed chemical products are sold, mobile retail vendors must self-certify for each location at which sales transactions occur. This self- certification for locations is required even if the same person or persons sell at each of the different locations.
DEA requests comments on who should be authorized to sign the self- certification for the regulated seller. The person should be in a position to know that all employees who require training have been trained and that the retail outlet is complying with all other requirements and should be authorized to sign documents for the regulated seller.
Time for self-certification. CMEA requires that regulated sellers self-certify by September 30, 2006. Although CMEA appears to link self- certification to training of each individual who will deliver the products to customers, the high rate of employee turnover in the retail sector could require frequent submissions of self-certifications if the regulated seller needed to recertify each time a new employee is trained. DEA, therefore, will require regulated sellers to self-certify by September 30, 2006. When regulated sellers file the initial self- certification, DEA will assign them to groups. Each group will have an expiration date that will be the last day of a month from 12 to 23 months after the initial filing. After the second self-certification, regulated sellers will be required to self-certify annually. It is the responsibility of the regulated seller to ensure that all employees have been trained prior to self-certifying each time. It is also the responsibility of the regulated seller to ensure that they self-certify before the self-certification lapses. DEA requests comments on annual self-certifications versus certifications whenever new employees are trained or quarterly self-certification.
Fee for self-certification. In a separate Notice of Proposed Rulemaking, DEA is proposing that regulated sellers who are not DEA registrants pay a fee for self-certification. While DEA is not making this fee effective with this Interim Rule, DEA is providing background discussion and rationale for this decision here so that all persons will be aware of this issue.
Section 886a of the CSA defines the Diversion Control Program as "the controlled substance and chemical diversion control activities of the Drug Enforcement Administration," which are further defined as the "activities related to the registration and control of the manufacture, distribution and dispensing, importation and exportation of controlled substances and listed chemicals." The CSA also states that reimbursements from the Diversion Control Fee Account "* * * shall be made without distinguishing between expenses related to controlled substances activities and expenses related to chemical activities." [Pub. L. 108-447 Consolidated Appropriations Act of 2005].
In addition, Section 111(b)(3) of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act of 1993 (Pub. L. 102-395), codified at 21 U.S.C. 886a(3), requires that "fees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program."
CMEA implements new requirements governing the sale of scheduled listed chemical products, defined as nonprescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. CMEA requires self-certification for all regulated sellers of scheduled listed chemical products. CMEA also exempts retail distributors from registration requirements under the CSA; however, in practice, retail distributors have not previously registered with DEA because they limited their sales to below threshold quantities and to products sold in blister packs.
DEA considers the self-certification requirements of the CMEA to fall within the legal definition of control as governed by Section 886a of the CSA (see above). Accordingly, these activities fall under the general operation of the Diversion Control Program and are subject to the requirements of the Appropriations Act of 1993 that mandates that fees charged shall be set at a level that ensures the recovery of the full costs of operating the various aspects of the Diversion Control Program. The self-certification requirements of CMEA fall under these
"various aspects." Therefore, in its Notice of Proposed Rulemaking, DEA will propose to charge a fee for each self-certification to comply with these statutory requirements.
DEA is proposing, in its separate Notice of Proposed Rulemaking, that the fee for self-certification will cover all associated costs, including the initial one-time costs of setting up the self- certification program, website, and programmatic infrastructure, as well as ongoing costs associated with the provision of self- certifications, call center support, maintenance of the self- certification system, printing costs for certificates that regulated sellers cannot print, financial management, and other related costs. DEA must establish a program to train its employees to provide information regarding, and accept, self-certifications and must establish the infrastructure necessary for the program. Required systems include creation of history, renewal cycles, investigative tools, business validation rules, and development and maintenance of the self-certification website.
In its Notice of Proposed Rulemaking, DEA is proposing that when regulated sellers submit a self-certification online via the DEA self- certification Web site that they pay a fee by credit card at the time of self-certification. DEA calculated this fee based on estimated set- up costs in Fiscal Year 2006 ($117,198) and Fiscal Year 2007 operating costs ($1,624,443) totaling $1,741,641, as shown below in Table 3. The initial systems development and set-up costs will not be repeated in subsequent years. The operational and maintenance costs for Fiscal Year 2008 are estimated to be $1,099,782. Total annual costs associated with operating the self-certification process include staff costs, operational and administrative costs, Web hosting, monitoring and maintenance costs (including hardware and software maintenance), and annual inflation adjustments. Therefore, DEA will propose in its separate Notice of Proposed Rulemaking, that the 89,000 persons DEA estimates will self-certify with the Administration would pay a self- certification fee of $32 for the Fiscal Year 2006 through Fiscal Year 2008 period.
To calculate the fee, DEA divided the total costs for Fiscal Years 2006 through 2008 by the anticipated population of affected regulated sellers of 89,000. DEA estimates 89,000 current retail vendors of scheduled listed chemical products. All costs are shown in the table below for Fiscal Years 2006 through 2008. The self-certification costs reflect the cost per each self-certification per each facility as required by CMEA.