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Chemical Handler's Manual

SECTION IX – RETAIL SALES OF SCHEDULED LISTED CHEMICAL PRODUCTS

This section is divided into four parts. The first part provides background information on amendments to the Controlled Substances Act concerning scheduled listed chemical products (SLCP). The second part pertains to both regulated sellers, such as retail stores, as well as mail-order distributors. The third part pertains only to regulated sellers. Finally, the fourth part pertains only to mail-order distributors.

Part 1: Background

In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). This Act amended the CSA to change the regulations for selling products that contain ephedrine, pseudoephedrine, and phenylpropanolamine that may be marketed or distributed lawfully in the U.S. under the Federal Food, Drug, and Cosmetic Act as nonprescription drugs. CMEA defines these products as SLCPs.

Face-to-face sales to a customer, by a regulated seller (including mobile retail vendors), are subject to requirements for training employees who either are responsible for delivering SLCPs into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products. The regulated seller must certify annually to the DEA that the employees have been trained. These regulated sellers must also check the identification of purchasers and maintain specific records (the logbook) of each sale of SLCPs. The only sales exempt from recordkeeping are purchases by individuals of single packages where the package contains not more than 60 milligrams of pseudoephedrine.

As of September 30, 2006, regulated sellers of SLCPs are required to maintain logbooks regarding their sales. The records must be readily retrievable and available for inspection and copying by the DEA or other state or local law enforcement agencies. Logs must be kept for not fewer than two years from the date the entry was made.

In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008 (MPPA) which facilitates the creation of electronic logbooks. The MPPA and its implementing regulations provide greater flexibility for regulated sellers of SLCPs to choose several alternative ways in which to capture and maintain required logbook information: a fully written logbook, a fully electronic logbook, or a logbook where some information is captured electronically and the prospective purchaser's signature is captured and linked to that information.

In October 2010, the President signed the Combat Methamphetamine Enhancement Act of 2010 (MEA). It established new requirements for mail-order distributors of SLCPs. Mail-order distributors must now train their employees and complete the self-certification process annually to sell SLCPs at retail. In addition, there is a provision in the law which makes it unlawful for both regulated sellers and mail-order distributors to negligently fail to self-certify. The MEA also mandated the DEA to make publicly available on its website, in an electronically downloadable format, a list of all persons who are currently self-certified. The DEA is developing a regulation to implement this MEA requirement.

Part 2: Requirements for Both Regulated Sellers and Mail-Order Distributors

Self-Certification Requirements

Information regarding this subject may be found at 21 U.S.C. § 830 and 21 C.F.R. §§ 1314.35 - 1314.42
and 1314.101 - 1314.103.

Before the regulated seller or mail-order distributor or individual employees may sell SLCPs, all regulated sellers and mail-order distributors must train their employees and complete the self-certification process which stipulates the employee(s) has been trained.

A separate self-certification is required for each separate physical location at which SLCPs are sold. Procedures are also available for chains to register multiple locations in a single transaction. Information regarding the chain self-certification process may be obtained by contacting the DEA Headquarters at 1-800-882-9539 or via e-mail at DEA.Registration.Help@usdoj.gov.

Mobile retail vendors must complete the self-certification process for each location at which sales transactions occur. The self-certification for each location is required even if the same person(s) sells at each of the different locations.

Self-certification is required for each mail-order distributor at each place of business at which there are retail sales of SLCPs. For a mail-order distributor, this would mean each location that prepares or packages product for distribution to customers, and each location where employees accept payment for such sales.

The process of self-certification for regulated sellers and mail-order distributors is subject to the provisions of 18 U.S.C. § 1001. A regulated seller or mail-order distributor who knowingly or willfully certifies to statements or representations that are not true is subject to fines and imprisonment. It is also unlawful for regulated sellers and mail-order distributors to negligently fail to self-certify as required under 21 U.S.C. § 830.

When the regulated seller (including a mobile retail vendor) and mail-order distributor self-certifies, the regulated seller or mail-order distributor is confirming that:

  1. Employees engaged in the sale of SLCPs have been trained regarding provisions of CMEA.
  2. Records of training are being maintained.
  3. Sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine, or phenylpropanolamine in a single day.
  4. For mobile retail vendors and mail-order distributors, sales to an individual in a 30-day period may not exceed 7.5 grams.
  5. Non-liquid forms are packaged as required.
  6. Regulated sellers store SLCPs behind the counter or in a locked cabinet.
  7. Mobile retail vendors store SLCPs in a locked cabinet.
  8. Regulated sellers properly maintain a written or electronic logbook.
  9. 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.

How to Self-Certify

The only way to self-certify is through the Internet at http://www.deadiversion.usdoj.gov/meth/index.html#self_cert. Self-certification can be accomplished on any computer - at home, at a public library, or at any other location. The DEA charges a fee for self-certification. At the end of the self-certification process, a credit/debit card will be needed to pay the self-certification fee. A printer will be needed to print the certificate for the location. If a printer is not available, the system can be prompted to mail the certificate.

It is the responsibility of mail-order distributors as well as regulated sellers to annually renew the self-certification before the certificate expires if they wish to continue selling SLCPs at retail. Once the expiration date has passed, the mail-order distributors and regulated sellers cannot recertify or update the self-certification. There is no authority to sell SLCPs until a new self-certification is completed.

Self-Certification Training Materials

The DEA has posted training materials on its website, http://www.deadiversion.usdoj.gov/meth/index.html#self_cert. Employers must use the DEA's training materials when training the employees who sell SLCPs. An employer may include content in addition to the DEA's information, but the DEA's material must be included in the training. For example, an employer may elect to incorporate the DEA's material into initial training for new employees.

Orders to Show Cause

Information regarding this subject may be found at 21 C.F.R. § 1314.150.

If it is determined that a regulated seller or a distributor required to submit reports under 21 C.F.R. § 1310.03(c) has sold a SLCP in violation of the CSA, (21 U.S.C. 842(a)(12) or (13)). The DEA will serve upon the regulated seller or distributor an order to show cause why the regulated seller or distributor should not be prohibited from selling SLCPs.

The order to show cause shall call upon the regulated seller or distributor to appear before the DEA at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the prohibition and a summary of the matters of fact and law asserted.

Upon receipt of an order to show cause, the regulated seller or distributor must, if he desires a hearing, file a request for a hearing as specified in 21 C.F.R. part 1316 subpart D. If a hearing is requested, the DEA shall hold a hearing at the time and place stated in the order. Any authorized agent of the DEA may serve the order to show cause.

Suspension Pending Final Order

Information regarding this subject may be found at 21 C.F.R. § 1314.155.

The DEA may suspend the regulated seller or distributor's right to sell SLCPs at the time of, or after, the issuance of an order to show cause why the regulated seller or distributor should not be prohibited from selling SLCPs; in any case where the DEA finds that there is an imminent danger to the public health or safety. An order of immediate suspension shall contain a statement of the DEA's findings regarding the danger to public health or safety.

Upon receiving the order of immediate suspension, the regulated seller or distributor shall, as instructed by the DEA Administrator:

  1. Deliver all of the SLCPs in his or her possession to the nearest DEA office or to DEA authorized agents; or
  2. Place all of the SLCPs under seal as described in 21 U.S.C. § 824(f).

Any suspension shall continue in effect until the conclusion of all proceedings upon the prohibition, including any judicial review, unless sooner withdrawn by the DEA or dissolved by a court of competent jurisdiction. Any regulated seller or distributor whose right to sell SLCPs is suspended under this section may request a hearing on the suspension at a time earlier than specified in the order to show cause. The DEA will establish a date for such hearing as early as reasonably possible.

Part 3: Requirements for Regulated Sellers

Employment Measures

Information regarding this subject may be found at 21 C.F.R. § 1314.50.

A regulated seller may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of SLCPs. This may include, notwithstanding State law, asking applicants whether they have been convicted of any crime involving or related to SLCPs or controlled substances.

Proof of Identity Requirements for Regulated Sellers

Information regarding this subject may be found at 21 C.F.R. § 1314.30.

The regulated seller must not sell an SLCP unless the purchaser presents an identification card that contains a photograph and is issued by a State or the Federal government. See Appendix J for a list of alternate forms of identification acceptable under 8 C.F.R. §§ 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).

General Logbook Requirements

Information regarding this subject may be found at 21 U.S.C. § 830 and 21 C.F.R. §§ 1314.30 and 1314.45.

Except for purchase by an individual of a single sales package containing not more than 60 milligrams of pseudoephedrine, the regulated seller must maintain, under criteria issued by the DEA, a written or electronic list of each SLCP sale that identifies the products by name, the quantity sold, the names and addresses of the purchasers, and the dates and times of the sales (referred to as the "logbook"). The logbook may be maintained on paper or in electronic form.

Logbook Requirements for Seller

Information regarding this subject may be found at 21 C.F.R. § 1314.30.

The regulated seller must enter in the logbook the name of the product and the quantity sold. Examples of methods to record the quantity sold include the weight of the product per package and number of packages of each chemical, the cumulative weight of the product for each chemical, or quantity of product by Universal Product Code. These examples do not exclude other methods of displaying the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology. Such electronic records must comply with the requirements of 21 C.F.R. § 1314.30(g) in a human readable form so that 21 C.F.R. § 1314.30(a) is satisfied.

The logbook maintained by the seller must include the prospective purchaser's name, address, and the date and time of the sale, as follows:

  1. If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on the identification and that the date and time entered are correct.
  2. If the seller enters the information, the prospective purchaser must verify that the information is correct.
  3. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

Warning Notice

Information regarding this subject may be found at 21 C.F.R. § 1314.30.

The regulated seller must include in the written or electronic logbook or display by the logbook the following notice:

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.

Logbook Requirements for Purchaser

Information regarding this subject may be found at 21 C.F.R. § 1314.30.

The purchaser signs the logbook as follows:

  1. For written logbooks, enters in the logbook his name, address, and the date and time of the sale.
  2. For electronic logbooks, provides a signature using one of the following means:
    1. Signing a device presented by the seller that captures signatures in an electronic format. The device must display the required warning notice. Any device used must preserve each signature in a manner that clearly links that signature to the other electronically captured logbook information relating to the prospective purchaser providing that signature.
    2. Signing a bound paper book. The bound paper book must include, for such purchaser, either:
      1. A printed sticker affixed to the bound paper book at the time of sale that either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or
      2. A unique identifier that can be linked to that information and that is written into the book by the seller at the time of sale.  The purchaser must sign adjacent to the printed sticker or written unique identifier of that sale.
    3. Signing a printed document that includes, for the purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. The document must be printed by the seller at the time of the sale. The document must contain a clearly identified signature line for a purchaser to sign. The printed document must display the required warning notice. Each signed document must be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.

Recordkeeping Requirements for Logbooks

Information regarding this subject may be found at 21 U.S.C. §§ 830 and 880 and 21 C.F.R. § 1314.30.

The regulated seller must maintain each entry in the written or electronic logbook for not fewer than two years after the date on which the entry is made.

A record must be kept at the regulated seller's place of business where the transaction occurred, except that records may be kept at a single, central location of the regulated seller if the regulated seller has notified the DEA of the intention to do so. Written notification must be submitted by registered or certified mail, return receipt requested, to the Special Agent in Charge of the DEA Divisional Office for the area in which the records are required to be kept.

The required records must be readily retrievable and available for inspection and copying by authorized employees of the DEA under the provisions of the CSA.

A record developed and maintained to comply with a State law may be used to meet these requirements if the record includes the information required by the CSA and its implementing regulations.

Privacy Protections

Information regarding this subject may be found at 21 U.S.C. § 830 and 21 C.F.R. § 1314.45.

The disclosure of information in logbooks is restricted as follows:

  1. The information shall be disclosed as appropriate to the DEA and to State and local law enforcement agencies.
  2. The information in the logbooks shall not be accessed, used, or shared for any purpose other than to ensure compliance with this title or to facilitate a product recall to protect public health and safety.
  3. A regulated seller who in good faith releases information in a logbook to Federal, State, or local law enforcement authorities is immune from civil liability for the release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.

Sales Limits at Retail

Information regarding this subject may be found at 21 U.S.C. §§ 830 and 844 and 21 C.F.R. §§ 1314.20 and 1315.03.

The CMEA established sales and purchase limits for SLCPs:

  1. Sales to individuals may not exceed 3.6 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a single day, regardless of the number of transactions.
  2. For mobile retail vendors, sales to an individual in a 30-day period may not exceed 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base.
  3. For purchasers, there is a 9 gram purchase limit for ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a 30-day period, not more than 7.5 grams of which may be imported by means of shipping through any private or commercial carrier or the Postal Service (see Appendix I).

Storage Requirements

Information regarding this subject may be found at 21 U.S.C. § 830 and 21 C.F.R. § 1314.25.

The regulated seller must place the SLCPs so that customers do not have direct access to the product before the sale is made (otherwise referred to as "behind-the-counter" placement). If the SLCPs are stored in a locked cabinet that is located in an area of the facility where customers do have direct access, this would comply with the "behind-the-counter" requirement. The regulated seller must deliver the SLCP directly into the custody of the purchaser. Mobile retail vendors must place the product in a locked cabinet.

Part 4: Requirements for Mail-Order Distributors

Proof of Identity Requirements for Mail-Order Distributors

Information regarding this subject may be found at 21 C.F.R. § 1314.105.

Prior to shipping the product, the mail-order distributor must receive from the purchaser a copy of an identification card that contains a photograph and is issued by a State or the Federal government, or an alternate form of identification considered acceptable under 8 C.F.R. §§ 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B), see Appendix J. Prior to shipping the product, the mail-order distributor must determine that the name and address on the identification card correspond to the name and address provided by the purchaser as part of the sales transaction. If the mail-order distributor cannot verify the identities of both the purchaser and the recipient, the product may not be shipped.

If the product is being shipped to a third party, the mail-order distributor must comply with the above described requirements to verify that both the purchaser and the person to whom the product is being shipped live at the addresses provided. If the mail-order distributor cannot verify the identities of both the purchaser and the recipient, the product may not be shipped.

Sales Limits for Mail-Order Distributors

Information regarding this subject may be found at 21 U.S.C. § 830 and 21 C.F.R. § 1314.100.

For mail-order distributors, the CMEA mandates that sales to an individual do not exceed 3.6 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a single calendar day, regardless of the number of transactions. CMEA also establishes a sales limit of not more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base to an individual per 30-day period.

Reports of Mail-Order Sales of SLCPs

Information regarding this subject may be found at 21 C.F.R. 1314.110.

Information regarding mail-order sales, including distributions for which reports are not required, can be found in Section VI, Reports to the DEA.

Each monthly report of SLCPs must provide the following information for each distribution:

  1. Supplier name and registration number;
  2. Purchaser's name and address;
  3. Name/address shipped to (if different from purchaser's name/address);
  4. Method used to verify the identity of the purchaser and person to whom product is shipped, where applicable;
  5. Name of the chemical contained in the SLCP and total quantity shipped (e.g., pseudoephedrine, 3 grams);
  6. Date of shipment;
  7. Product name;
  8. Dosage form (e.g., tablet, liquid);
  9. Dosage strength (e.g., 30 mg, 60 mg, per dose, etc.);
  10. Number of dosage units (e.g., 100 doses per package);
  11. Package type (blister pack, etc.);
  12. Number of packages; and
  13. Lot number.

Reports of mail-order sales should be sent to:

Drug Enforcement Administration
Attn: Import/Export Unit/DRGI
8701 Morrissette Drive
Springfield, VA 22152

The written reports must be submitted on or before the 15th day of each month following the month in which the distributions took place. If the report is submitted in writing, the report must be submitted under company letterhead, signed by the person authorized to sign the registration or self-certification on behalf of the regulated person or regulated seller, respectively. Upon request to, and approval by, the DEA, a regulated person may submit this report electronically to the DEA.

Section VIII | Table of Contents | Appendices

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