-------------------------------------------------------------------------- Comprehensive Methamphetamine Control Act FAQ -------------------------------------------------------------------------- January 7, 1998 Question: Is a business that warehouses pseudoephedrine drug products for a major distributor and delivers to the major distributor's customer, a military commissary, required to register? Answer: Yes, CFR 1309.21 states every person who distributes, imports, or exports any List I Chemical shall obtain annually a registration specific to the List I Chemicals to be handled. The Comprehensive Methamphetamine Control Act of 1996 (MCA) eliminated the exemption for legal drug products which contain either combination ephedrine, pseudoephedrine, or phenylpropanolamine. It was required that those who distribute these List I Chemical drug products submit an application for registration with the Drug Enforcement Administration on or before December 3, 1997 for pseudoephedrine and phenylpropanolamine drug products and on or before July 12, 1997 for combination ephedrine drug products, unless otherwise exempt. Those who missed these application deadlines are required to both submit an application and have the application approved before they can legally distribute these products. Question: Are there additional case examples or scenarios that may be encountered as a result of the Comprehensive Methamphetamine Control Act of 1996? Answer: Presented for your information are actual product diversion case examples reported to DEA. These may be indicative of the type of activities that may be encountered. DEA does not recommend store personnel become engaged in personal confrontation but that police authorities be notified. 1) In July 1997, U.S. Border Patrol agents seized over one million pseudoephedrine tablets concealed in a motor home at a border checkpoint in the southwestern United States. Invoice information indicated that the tablets had been sold to a company, a wholesale general merchandise/wholesale grocer. The company which sold the pseudoephedrine is described by Dunn &Bradstreet codes as a wholesale business involved in non-durable goods (gifts and novelties). 2) Subsequent to a drug investigation in July 1997, law enforcement personnel in the western United States arrested three subjects and seized a total of 144 cases of pseudoephedrine tablets, which contained 144 bottles of 60 count x 60 milligram (mg) pseudoephedrine tablets (a total of 1,244,160 tablets). Follow-up investigation revealed that the pseudoephedrine had been sold by an import/export, general warehousing, and transportation facility to a wholesale supplier of variety store goods. NOTE: Each case (144 bottles of 60 count x 60 mg pseudoephedrine tablets - a total of 8,640 tablets) contains enough pseudoephedrine to illicitly manufacture approximately 11 ounces of methamphetamine. 3) In July 1997, DEA personnel in the western United States seized approximately 142 cases of pseudoephedrine tablets, which had been repackaged into 21 plain boxes. The cases had been shipped from a wholesaler of nondurable goods (gifts and novelties). According to the subject taken into custody, the pseudoephedrine was purchased as a "side job" for his/her truck stop distributor’s business on a "cash basis" for someone else. Subsequent investigation revealed that a total of 120 cases had previously been shipped to this same company. 4) In August 1997, DEA personnel in the western United States seized 40 cases of pseudoephedrine tablets, each containing 288 bottles of 120 count x 60 mg pseudoephedrine tablets (a total of 1,382,400 tablets). The pseudoephedrine was sold from a wholesaler of nondurable goods (gifts and novelties) to a wholesaler of food products. The pseudoephedrine had been seized at a distribution center (transshipment point) and had been labeled as "foodstuff/vitamins." NOTE: Each of these cases (288 bottles of 120 count x 60 mg pseudoephedrine tablets--a total of 34, 560 tablets) contains enough pseudoephedrine to illicitly manufacture approximately 1.24 kilograms (2.7 pounds) of methamphetamine. 5) In August 1997, fire department and police personnel responded to an apartment fire on the East Coast. The suspect was arrested upon his return to the apartment after having taken his girlfriend to the hospital for second and third degree burns over 40 percent of her body. A subsequent search of the residence revealed that the source of the fire was the presence of an extraction laboratory. (An extraction laboratory removes ephedrine/pseudoephedrine from over-the-counter products using a chemical process that separates the desired final product from the binders and other ingredients contained in the tablets. This reduces the ephedrine/pseudoephedrine into a bulk, powder form to be used in the illicit manufacture of methamphetamine. The same process may be used for over-the-counter phenylpropanolamine products for the illicit manufacture of amphetamine.) 6) In September 1997, police seized 132 boxes of pseudoephedrine tablets (over one million tablets) during a traffic stop in the Mid-West. Each box contained 144 bottles of 60 count x 60 mg pseudoephedrine tablets. The subject detained in this case obtained the pseudoephedrine from an import company. 7) In September 1997, fire department personnel on the West Coast responded to a report of smoke coming from a residence. The source of the fire was an explosion from a clandestine methamphetamine laboratory. 8) In September 1997, a clandestine methamphetamine laboratory was seized from a residence in the Southwestern United States. The lab was discovered by law enforcement personnel who were investigating a possible negligent homicide involving a four-year old child who may have been poisoned by the chemicals/fumes from the lab. 9) In October 1997, law enforcement and fire department personnel responded to a suspicious fire in the Mid-West. The apparent cause of the fire was determined to be a clandestine methamphetamine laboratory, which was found in the attic along with the body of one female who had died in the blaze. -------------------------------------------------------------------------- October 23, 1997 SUBMISSION FOR DEA DIVERSION Question: Regarding Chemical Registration, has there been an official change in the chemical application fee amount and the application deadline? Response: DEA published two notices in the Federal Register on October 17, 1997 relating to the implementation of the Comprehensive Methamphetamine Control Act of 1996. The first notice relates to DEA's waiving a substantial portion of the chemical application fee for distributors of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. Effective upon publication, the application fee for a chemical registration to distribute pseudoephedrine, phenylpropanolamine, or combination ephedrine drug products has been reduced from $595.00 to $116.00. Additionally, persons who have already submitted applications for registration to distribute pseudoephedrine, phenylpropanolamine, or combination ephedrine drug products and paid the $595.00 application fee will receive a refund in the amount of $479.00. The second notice is an interim rulemaking amending the regulations to provide an extension of the application deadline for chemical handlers to December 3, 1997. Any person who submits an application on or before December 3, 1997, may continue legitimate business with pseudoephedrine and/or phenylpropanolamine drug products without a registration pending final action on their application by DEA. Internet users can obtain copies of the notices from the government printing office web site at www.access.gpo.gov. -------------------------------------------------------------------------- October 6, 1997 Questions Received from Industry/Drug Enforcement Administration Responses The following questions and responses pertain to the general provisions of the Comprehensive Methamphetamine Control Act of 1996. Question: If my application to handle ephedrine combination products, pseudoephedrine, and phenylpropanolamine was filed after the July 12, 1997 deadline, will that adversely effect my ability to handle drug products that contain pseudoephedrine and phenylpropanolamine? Answer: No, the regulatory controls of pseudoephedrine and phenylpropanolamine products do not go into effect until October 3, 1997. DEA will consider your application on time for those products. The inability to handle ephedrine combination products is the only restriction imposed because of the missed July 12 deadline. Upon approval of your application, you may resume handling that product also. Question: Does a distributor who distributes only pseudoephedrine prescription products have to register? Answer: Pursuant to Title 21 Code of Federal Regulations, (21 CFR), Section 1309.28, the requirement for registration is waived for any person who distributes a prescription drug product containing a List I Chemical that is already regulated pursuant to (21 CFR) 1300.02(b)(28). Question: What records are required of a distributor who distributes only List I prescription drug products? Answer: The Food and Drug Administration records relating to distribution of prescription drugs under 21 CFR Part 205 will satisfy DEA's chemical record requirement. Question: What constitutes a Suspicious Order and how can Suspicious Orders be easily recognized? Answer: The DEA has frequently been asked for guidance on what constitutes a suspicious order. Repeated below are the items identified in the Chemical Handlers Manual, pending reprint. This material is useful and will be supplemented with the results of the work of the Suspicious Orders Task Force created under the Methamphetamine Control Act. The reporting of a suspicious order is required by the Controlled Substances Act and is of primary importance to DEA in limiting the availability of listed chemicals in the illicit traffic. Each regulated person is most familiar with its customers and the circumstances surrounding the orders it processes. The chemical industry must use its best judgment in identifying suspicious orders. The following are provided in order to assist the industry in identifying suspicious orders: 1. An individual who desires to pay cash and wants to pick up the chemical(s). 2. An established customer who deviates from previous orders or ordering methods. 3. A new customer or unfamiliar representative of an established customer who orders listed chemicals. 4. A customer who has difficulty in pronouncing chemical names. 5. A customer who is vague about its firm's address, telephone number, and reason for desiring a listed chemical. 6. A customer who wants a listed chemical shipped to a post office box or address other than the usual business address. 7. A customer who prefers to pay by cashier's check, postal money order, etc. 8. A customer who will not furnish references or who is vague about furnishing references for credit purposes. 9. A customer who desires listed chemicals for reasons at variance with accepted legitimate industry practice. 10. A customer who is not a member of a trade, professional, or business association. 11. A customer who furnishes false or suspicious addresses, telephone numbers, or references. 12. A customer who refuses or is reluctant to establish a credit account or provide purchase order information. 13. A customer whose communication either by telephone, mail, or other means is not conducted or prepared in a professional business manner. 14. A customer who requests unusual methods or routes of shipment or who provides unusual shipping, labeling or packaging instructions. 15. A customer who purchases unusual quantities or combinations of chemicals or glassware in contrast with customary practice and usage. 16. A customer whose stated use of listed chemicals is incompatible with destination country's commercial activities or consignee's line of business. 17. A customer with little or no business background information available. 18. A customer using a freight forwarder as ultimate consignee. 19. The use of intermediate consignee(s) whose location or business is incompatible with the purported end user's nature of business or location. 20. Evasive responses to any questions, or responses that indicate a lack of basic knowledge of the industry, or inability to supply information on whether listed chemicals are for domestic use or export. This list is not all inclusive. It is ultimately the responsibility of the supplier to recognize a suspicious order. Question: How is a DEA Chemical Registration Control Number constructed? Answer: The Control Number assigned is unique for each applicant. An explanation follows. CONSTRUCTION OF DEA CHEMICAL REGISTRATION CONTROL NUMBER The chemical registration control number, which is a temporary number issued until final registration is approved, has a total of ten characters. FOR EXAMPLE: CONTROL NUMBER: K22102101E 1: The first digit is K , which indicates 'chemicals.' 2-4: These numbers indicate the Julian date. 5-7: These are random numbers that are computer generated. 8-9: These are random numbers that are computer generated which indicate the number of the each application in a 'batch.' 10: This is a letter which is a code for the year. Question: Will the DEA continue to provide case examples or scenarios that may be encountered as a result of the Comprehensive Methamphetamine Control Act of 1996? Answer: Presented for your information is an actual case example reported to DEA. This may be indicative of the type of activities you may encounter. DEA does not recommend store personnel become engaged in personal confrontation but that police authorities be notified. In August 1997, a retail store in the Mid-West reported the theft of approximately 200 boxes of over-the-counter (OTC) products containing pseudoephedrine. These thefts took place over several weekends after the store had re-stocked its shelves on Friday night. Upon entering the store on the following Mondays, the manager noticed that the shelf containing OTC pseudoephedrine products was empty. Upon checking the inventory, she found that none of the boxes (24 and 48 count) of 60 milligram pseudoephedrine tablets had been purchased. On one weekend, it was noticed by store staff that these OTC products were gone on Saturday morning. The store's manager also reported finding a shopping cart near the front of the store which contained OTC pseudoephedrine products and which had apparently been abandoned. In another instance, a male who entered the store became very upset when he found out that the shelves containing these products were empty. This store has recently removed these products from their shelves, concerned that if they are placed back on the shelves on Friday night, they will be gone by Saturday morning. The store manager contacted the regional Loss Prevention representative in her area, who in turn contacted DEA for guidance. Due to the distance of this store from the nearest DEA office, the store is being directed to contact their local law enforcement agency. Furthermore, the regional Loss Prevention manager also mentioned installing 24 hour surveillance cameras in an effort to identify the perpetrators involved. Questions Received from Industry/Drug Enforcement Administration Responses The purpose of this summary is to report recent questions from industry representatives that were not addressed in DEA general guidance questions/answers. It is our intention to provide summaries periodically in order to assist industry in complying with legislation. The following questions and responses pertain to the general provisions of the Comprehensive Methamphetamine Control Act of 1996. Question: Will DEA provide a pseudoephedrine/methamphetamine "notice" for voluntary use by firms which could be included within shipments and inform distributors about the need to monitor products which may be diverted to clandestine laboratories? Answer: NOTICE Important Information to Manufacturers, Distributors and Retailers of OTC Pseudoephedrine and Phenylpropanolamine Drug Products Law enforcement authorities nationwide are witnessing an alarming increase in the illicit production and use of methamphetamine using OTC pseudoephedrine and phenylpropanolamine (PPA) drug products. Despite increased domestic and international enforcement actions that have reduced the availability of bulk ephedrine and pseudoephedrine, clandestine laboratory operators have responded by using OTC pseudoephedrine and PPA drug products. The Drug Enforcement Administration (DEA) and law enforcement authorities wish to bring to your attention that drug products containing pseudoephedrine and PPA are List I Chemicals under Federal Law. These chemicals are used in the manufacturing of cough, cold and allergy products. Anyone who manufactures, imports, exports or distributes (including selling to the consumer) a listed chemical is considered a "regulated person". Any person who possesses or distributes a listed chemical knowing, or having reasonable cause to believe that it will be used to manufacture a controlled substance, shall be fined, or imprisoned not more than 10 years, or both. (The law provides for an imprisoned term of not more than 20 years when the listed chemical is used in the manufacture of methamphetamine.) The law becomes effective on October 3, 1997. DEA is seeking voluntary cooperation by industry to reduce the diversion of these OTC products. More specific information regarding this issue may be obtained from your local DEA office. Question: How is a DEA chemical registration number constructed? How does this differ from the registration number for controlled substances? Answer: CONSTRUCTION OF DEA CHEMICAL REGISTRATION NUMBER A DEA chemical registration number is easily distinguished from a controlled substance number. The chemical registration has a total of nine characters. 1-6: Its first six are numbers, followed by 7: Alpha (First alpha in the registrant name), followed by 8: Alpha (random letter), followed by 9: alpha (Alpha letter that identifies the activity of the chemical registrant. 1 Numerical 2 -"- 3 -"- 4 -"- 5 -"- 6 -"- 7 Alpha - First letter in registrant's name 8 Alpha - Random letter 9 Alpha - Letter code that identifies the chemical activity Example Codes for Ninth Character W - Manufacturer (for distribution) Y - Distributor V - Retail Distributor X - Importer Z - Exporter Note: There is no check numeric digit like a controlled substance number. Question: If an unregistered company repackages List I Chemicals for a registered company for distribution to the registered company's customers, does the repackaging company need to be registered? Answer: If the repackaging company, acting as the agent of the registered company, returns the repackaged List I Chemicals to the supplying registered company, with no other distribution of the List I Chemicals by the repackaging company, then, per 21 CFR 1309.24, the requirement of registration is waived for the repackaging company, provided that the repackaging company is acting in the usual course of its business or employment. If the repackaged List I Chemicals are distributed to customers from the repackaging facility and/or the repackaging facility takes orders for the List I Chemicals, then a registration would be required at the repackaging facility. Question: Can an applicant who distributes ephedrine, pseudoephedrine and/or phenylpropanolamine products register at his/her residence but store the products at an unregistered off-site warehouse or storage locker, etc? Answer: 21 CFR 1309.71 requires that all applicants and registrants provide effective controls and procedures to guard against theft and diversion of List I Chemicals. Storage of ephedrine, pseudoephedrine and/or phenylpropanolamine products at an unregistered off-site location such as a warehouse or storage locker would be allowed provided that the products are securely locked up at the off-site facility and that access to the products is limited to the registrant. Also, the List I Chemicals would have to be returned to the registered location for distribution to customers. Question: Can a chart be developed to assist in simplifying and clarifying compliance with the Methamphetamine Control Act? Answer: Charts relating to Retail Distributors, Distributors, Wholesale Distributors, and Importers/Exporters follow. Retail Distributors of Ephedrine/Pseudoephedrine/Phenylpropanolamine Effective Registration Transaction Records Reports Date Limit 0 Threshold as of Single Entity YES 11/10/94 YES 4/17/94 YES Ephedrine for all All for all transactions transactions transactions are regulated Combination YES 24 YES 10/3/96 grams/single YES Ephedrine if greater transaction if greater than 24 grams than 24 grams Pseudoephedrine Ordinary OTC N/A EXEMPT EXEMPT EXEMPT EXEMPT (Blister pack and <3 grams/pack) Pseudoephedrine Other than Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Non-blister pack if greater transaction if greater or than 24 grams than 24 grams >3 grams/pack) Phenylpropanolamine Ordinary OTC N/A EXEMPT EXEMPT EXEMPT EXEMPT (Blister pack and <3 grams/pack) Phenylpropanolamine Other than Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Non-blister pack if greater transaction if greater or than 24 grams than 24 grams >3 grams/pack) This publication is intended to serve only as general guidance. For information on the specific requirements of the MCA consult Public Law P.L. 104-237. Distributors who report per 21 USC 830 (b)(3) (Mail Orders) of Ephedrine/Pseudoephedrine/Phenylpropanolamine Effective Registration Transaction Records Reports Date Limit 0 Threshold as of Single Entity YES 11/10/94 YES 4/17/94 YES Ephedrine for all All for all transactions transactions transactions are regulated Combination YES 24 YES 10/3/96 grams/single YES Ephedrine for all transaction if greater transactions than 24 grams Pseudoephedrine Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Blister pack and for all transaction if greater transactions than 24 grams <3 grams/pack) Pseudoephedrine Other than Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Non-blister pack for all transaction if greater or transactions than 24 grams >3 grams/pack) Phenylpropanolamine Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Blister pack and for all transaction if greater transactions than 24 grams <3 grams/pack) Phenylpropanolamine Other than Ordinary OTC YES 24 YES 10/3/97 grams/single YES (Non-blister pack for all transaction if greater or transactions than 24 grams >3 grams/pack) This publication is intended to serve only as general guidance. For information on the specific requirements of the MCA consult Public Law P.L. 104-237. Wholesale Distributors of Ephedrine/Pseudoephedrine/Phenylpropanolamine Effective Registration Transaction Records Reports Date Limit 0 Threshold as Single Entity YES of 11/10/94 YES 4/17/94 YES Ephedrine for all All transactions for all transactions transactions are regulated Combination YES YES 10/3/96 1 YES Ephedrine for all kilo-cumulative if greater transactions than 1 kilo Pseudoephedrine Ordinary OTC YES YES 10/3/97 1 YES (Blister pack and for all kilo-cumulative if greater transactions than 1 kilo <3 grams/pack) Pseudoephedrine Other than Ordinary OTC YES YES 10/3/97 1 YES (Non-blister pack for all kilo-cumulative if greater or transactions than 1 kilo >3 grams/pack) Phenylpropanolamine YES Ordinary OTC YES 10/3/97 2.5 if greater YES (Blister pack and for all kilo-cumulative than 2.5 transactions kilos <3 grams/pack) Phenylpropanolamine Other than Ordinary YES OTC YES 10/3/97 2.5 if greater YES (Non-blister pack for all kilo-cumulative than 2.5 or transactions kilos >3 grams/pack) This publication is intended to serve only as general guidance. For information on the specific requirements of the MCA consult Public Law P.L. 104-237. Importers/Exporters of Ephedrine/Pseudoephedrine/Phenylpropanolamine Effective Registration Transaction Records Reports Date Limit 0 Threshold as Single Entity YES of 11/10/94 YES 4/17/94 YES Ephedrine for all All transactions for all transactions transactions are regulated Combination YES YES 10/3/96 1 YES Ephedrine for all kilo-cumulative if greater transactions than 1 kilo Pseudoephedrine Ordinary OTC YES YES 10/3/97 1 YES (Blister pack and for all kilo-cumulative if greater transactions than 1 kilo <3 grams/pack) Pseudoephedrine Other than Ordinary OTC YES YES 10/3/97 1 YES (Non-blister pack for all kilo-cumulative if greater or transactions than 1 kilo >3 grams/pack) Phenylpropanolamine YES Ordinary OTC YES 10/3/97 2.5 if greater YES (Blister pack and for all kilo-cumulative than 2.5 transactions kilos <3 grams/pack) Phenylpropanolamine Other than Ordinary YES OTC YES 10/3/97 2.5 if greater YES (Non-blister pack for all kilo-cumulative than 2.5 or transactions kilos >3 grams/pack) This publication is intended to serve only as general guidance. For information on the specific requirements of the MCA consult Public Law P.L. 104-237. Question: What is the procedure for obtaining status of an application for chemical registration? Answer: There is generally no need to be concerned about the application status. Each application submitted during the exemption period allows those business activities applied for to continue uninterrupted until notified differently by DEA. Refer to Federal Register, May 21, 1997, No 98 ( 62 FR 27693). If an applicant has reason to need information about the status of a chemical application, the applicant should contact their local DEA office and ask to speak with a Diversion Investigator who will assist them. Question: Can the DEA provide case examples or scenarios that may be encountered as a result of the Comprehensive Methamphetamine Control Act of 1996? Answer: Presented for your information are two actual case examples reported to DEA. These may be indicative of the type of activities you may encounter. DEA does not recommend store personnel become engaged in personal confrontation but that police authorities be notified. 1) In June 1997, a female customer entered a retail store in a western state to purchase 100 count bottles of pseudoephedrine OTC product, specifically requesting a well known brand name. Due to previous diversion issues with such products, this retail store had placed them on the shelves directly in front of the pharmacy counter under the observation of the pharmacy's staff. After the customer inquired where these products were kept, the pharmacy technician noticed that the customer had loaded all shelf stock 100 count bottles into her shopping cart, along with blister packages and the plastic display cases. When the customer approached the pharmacy's register, she was advised that she could only purchase five (5) of any of the packages she had in her cart. The customer chose 5 x 100 count bottles containing 30 mg pseudoephedrine tabs. The pharmacist then asked for the customer's identification and copied the information down from her driver's license. A follow-up investigation by law enforcement revealed that this female had recently purchased several other chemicals (such as iodine crystals) used in the illicit manufacture of methamphetamine. 2) In June 1997, a male stole 3 x 100 count bottles of OTC pseudoephedrine tablets from a retail store in a western state. Pharmacy employees reported that they had noticed this man, accompanied by a woman whose membership card was used to gain entrance into the store, came in every other day, individually or together, and purchased 100 count bottles of pseudoephedrine. The store's Loss Prevention Manager followed the couple to their car and asked to see the man's store card. When the man produced his companion's card, the manager confiscated it and later turned their license plate number over to law enforcement. The couple had previous records involving drug trafficking. Question: Do firms that are reporting mail order transactions have to report sales that are below the threshold for the product? Answer: Yes, the Comprehensive Methamphetamine Control Act of 1996, Section 402, states the following: "(A) Mail order reporting... Each regulated person who engages in a transaction with a nonregulated person which (I) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and (II) Uses or attempts to use the Postal Service or any private or commercial carrier shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data." (B) The data required for such report shall include: "(I) The name of the purchaser, (II) The quantity and form of the chemical [ephedrine, pseudoephedrine, or phenylpropanolamine] purchased, and (III) The address to which the chemical [ephedrine, pseudoephedrine, or phenylpropanolamine] was sent." While not required at this time, the date of each transaction, the trade name, and the lot number of the product distributed (where applicable) are requested. Reports should be mailed to: Drug Enforcement Administration Office of Diversion Control Domestic Chemical Operations Section (ODCD) Washington, D.C. 20537 Mail order reporting guidelines were published in the Federal Register, February 7, 1997, No 26 (62 FR 5851). Question: Are retail outlets required to be registered with the DEA to handle ephedrine combination products? Answer: Retail registration is waived under certain conditions. The Code of Federal Regulations, 21 CFR 1309.29 states: "The requirement of registration is waived for any retail distributor whose activities with respect to List I Chemicals are restricted to the distribution of below threshold quantities of a combination ephedrine drug product in a single transaction to an individual for legitimate medical use. The threshold for a distribution of a combination ephedrine drug product in a single transaction to an individual for legitimate medical use is 24 grams of ephedrine base." Issue: Many large distributors of controlled substances have for a number of years used the registration database to help ensure that those substances are distributed only to authorized persons. A similar application for verifying the registration of chemical registrants would be helpful for the purposes of verifying DEA Registrations issued to Manufacturers, Distributors, Importers, and Exporters of List 1 Chemicals: Question: Are these classes of registrants currently included in the master listing of DEA Controlled Substance registrants which is distributed through the National Technical Information Service (NTIS)? Answer: No, not at present. Question: If not, is a separate listing of List 1 Chemical Registrants available through the NTIS, DEA, or any other source? Answer: No, not at present. Question: Would the DEA consider exploring ways to make such list available to industry, perhaps on a limited basis? Answer: Yes, this issue is being addressed by DEA's Office of Domestic Chemical Operations (ODCD). ODCD is in the process of working with NTIS to provide a separate listing of List I Chemical Registrants. ODCD will also request that List I Chemical Registrants be included on the master listing of DEA Controlled Substance Registrants because some CSA registrants handle controlled substances and List I Chemicals, and they are not required to obtain a separate chemical registration. DEA is also seeking legal counsel regarding the use of the DEA Internet Home Page to facilitate making this information available to authorized inquiries. Question: On the Application for Chemical Registration, DEA Form 510, which Business Activity category should be checked in question number one if the business is classified as a "Wholesaler?" Answer: Distributor, because, according to 21 CFR 1300.02 (a)(29), "The term retail distributor means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to drug products containing pseudoephedrine, phenylpropanolamine, or ephedrine are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales. For the purposes of this paragraph, sale for personal use means the distribution of below-threshold quantities in a single transaction to an individual for legitimate medical use." If a firm's activities do not meet this definition, then they are a "Distributor." Question: Will DEA issue a chemical registration to a Post Office Box? Answer: No. 21 USC 822 (2)(e) states the following, "A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or List I Chemicals." A registrant may include a Post Office Box in addition to the physical location where the activities are carried out. Therefore, the registration must reflect the location from which the chemicals are distributed, imported, or exported. Question: At Distribution Centers, does DEA consider it suspicious and, therefore, require notification each time the cumulative threshold of one kilogram for pseudoephedrine and 2 1/2 kilograms for phenylpropanolamine products are reached in a calendar month? Answer: Not necessarily, the threshold establishes the point at which the recordkeeping and reporting requirements apply to a transaction. There is no automatic suspicion attached to reaching the threshold. Other factors must be considered such as what has been normal prior sales history for this customer? Is it a large scale distributor? The totality of elements surrounding the transaction should be considered in making such a determination. ----------------------------------------------------------------------------