Chemical Program > Q&As > Comprehensive Methamphetamine Control Act

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?

Are there additional case examples or scenarios that may be encountered as a result of the Comprehensive Methamphetamine Control Act of 1996 (MCA)?

Does a distributor who distributes only pseudoephedrine prescription products have to register?

What records are required of a distributor who distributes only List I prescription drug products?

Will the Drug Enforcement Administration (DEA) continue to provide case examples or scenarios that may be encountered as a result of the Comprehensive Methamphetamine Control Act of 1996?

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?

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?

Can a chart be developed to assist in simplifying and clarifying compliance with the Methamphetamine Control Act?

Are retail outlets required to be registered with the DEA to handle ephedrine combination products?

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)?

Would the DEA consider exploring ways to make such list available to industry, perhaps on a limited basis?

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?

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.

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: 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.

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 Code of Federal Regulations (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.