A. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was signed into law on March 9, 2006, to regulate, among other things, retail over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products. Retail provisions of the CMEA include daily sales limits and 30-day purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, employee training, and self-certification of regulated sellers. The CMEA is found as Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Public Law 109-177).

A. Ephedrine, pseudoephedrine, and phenylpropanolamine are precursor chemicals used in the illicit manufacture of methamphetamine or amphetamine. They are also common ingredients used to make cough, cold, and allergy products. Methamphetamine laboratories have been found in homes, cars, hotel rooms, storage facilities – these are generally referred to as "clandestine labs". Passage of the CMEA was accomplished to curtail the illicit production of methamphetamine. States that have enacted similar or more restrictive retail regulations have seen a dramatic drop in small clandestine labs.

A. Methamphetamine, which is chemically related to amphetamine, is a powerfully addictive drug that severely affects users’ minds and bodies, ruins lives, and endangers communities and the environment. Chronic use can lead to extremely violent behavior, the neglect of the user’s children, and an inability to cope with the ordinary demands of life. Unfortunately, methamphetamine, unlike other highly abused controlled substances such as cocaine and heroin, can be easily manufactured with common household agents. The manufacturing process, however, is dangerous, and those engaging in the process run the risk of chemical explosions and exposing their families and communities to toxic chemicals.

A. Methamphetamine or "meth" has become a tremendous challenge for the entire nation. At least one clandestine methamphetamine laboratory has been found in every state over the past five years. A July 18, 2006, National Association of Counties Survey found that meth is the leading drug-related local law enforcement problem in the country. The survey of 500 county law enforcement officials in 44 states found that meth continues to be the number one drug problem – 48% of the counties report that meth is the primary drug problem – more than cocaine (22%), marijuana (22%) and heroin (3%) combined. In addition, according to the survey, crimes related to meth continue to grow – 55% of law enforcement officials report an increase in robberies or burglaries in the last year and 48% report an increase in domestic violence.

A. Clandestine methamphetamine laboratories pose a significant danger in the community, as they contain highly flammable and explosive materials. Additionally, for each pound of methamphetamine produced, five to seven pounds of toxic waste remain, which is often introduced into the environment via streams, septic systems, and surface water run-off.

A. The CMEA mandates that DEA establish total annual requirements for these chemicals for the United States, and provide individual import, manufacturing and procurement quotas to DEA-registered importers and manufacturers that wish to conduct import and manufacturing activities with these chemicals.

The CMEA places additional regulatory controls upon the manufacture, retail sale, importation and exportation of the three List I chemicals. Specifically, CMEA amended the Controlled Substances Act (CSA) by adding ephedrine, pseudoephedrine, and phenylpropanolamine to 21 U.S.C. § 826. Section 826 requires DEA to establish total annual needs for each of the three chemicals and to limit manufacturing of these chemicals to the amount needed to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export purposes, and for the maintenance of reserve stocks, as are also applied to schedule I and II controlled substances. CMEA also added ephedrine, pseudoephedrine, and phenylpropanolamine to 21 U.S.C. § 952, to stipulate that importation of these three chemicals is prohibited except for that amount which the Attorney General (DEA by delegation) finds to be necessary for medical, scientific, or other legitimate purposes.

A. To implement these new requirements, DEA is establishing the assessment of annual needs (AAN) for ephedrine, pseudoephedrine and phenylpropanolamine.

DEA has promulgated new regulations establishing the procedures by which the assessment of annual needs, as well as individual import, manufacturing, and procurement quotas, will be administered.

A. The establishment of procedures for the administration of import, manufacturing, and procurement quotas, as well as the assessment of annual needs, will be of interest to persons importing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine or products containing those List I chemicals. It will also be of interest to persons manufacturing the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine, and products containing those List I chemicals. The term "manufacture" is defined in the CSA as "the production, preparation, propagation, compounding, or processing of a drug or other substance, … and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice." [21 U.S.C. 802(15)]

A. The requirements regarding establishment of procedures for the administration of import, manufacturing, and procurement quotas, as well as the assessment of annual needs, do not apply to exporters, distributors, regulated sellers, and mail order distributors.

A. The assessment of annual needs (AAN) represents the total quantity of ephedrine, pseudoephedrine, and phenylpropanolamine determined to be necessary to be manufactured and imported during the calendar year to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. The proposed AAN was published on October 19, 2006 in the Federal Register. Interested parties had the opportunity to provide public comments on the proposed AAN. The comment period closed December 4, 2006. After considering all comments received, DEA will publish the established AAN for 2007. The AAN will be revised at least once during the calendar year to which it applies.

A. Since the manufacture and importation of ephedrine, pseudoephedrine, and phenylpropanolamine have not been previously regulated through the establishment of an assessment of annual needs, DEA received assistance from a private independent contractor, IMS Health (IMS) in assessing the medical needs of the United States for ephedrine and pseudoephedrine. IMS’ methodology and initial estimates used in the proposed assessment (IMS Report) were based on making three independent measures derived from 2005 data. After each of the three independent measures was calculated for ephedrine and pseudoephedrine, IMS then took a weighted average of the three individual estimates in order to derive its initial estimate which DEA then considered.

The IMS Report is part of the public docket for the Assessment of Annual Needs Federal Register notice. 

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. Therefore, for purposes of calculating the medical needs of the United States for phenylpropanolamine, DEA considered the drug’s use in veterinary products only. DEA contacted the Food and Drug Administration to identify those companies that sold veterinary products containing phenylpropanolamine and then contacted each company to obtain information relating to sales of their phenylpropanolamine-containing products.

For the proposed 2007 assessment of annual needs, after DEA considered the medical needs for ephedrine, pseudoephedrine and phenylpropanolamine (veterinary products), it then considered: 1) industrial needs of the United States, 2) lawful export requirements, and 3) maintenance of reserve stocks to determine the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.

For the proposed 2007 assessment of annual needs, in consideration of the industrial needs of the United States for these three chemicals, DEA considered the use of ephedrine for the domestic manufacture of pseudoephedrine in 2005 and the amount of phenylpropanolamine used for the domestic manufacture of amphetamine in 2005.

For the proposed 2007 assessment of annual needs, in consideration of the requirements for lawful export purposes for these three chemicals, DEA considered all 2005 exports of these chemicals, as provided by DEA-registered exporters on the DEA Form 486 "Import/Export Declaration – Precursor and Essential Chemicals."

For the proposed 2007 assessment of annual needs, DEA considered additional requirements for the maintenance of reserve stock requirements.

A. DEA published its proposed assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on October 19, 2006 (71 FR 61801). DEA sought comments regarding this proposal. The comment period closed December 4, 2006. After consideration of all comments received, DEA will publish the initial established assessment of annual needs in the Federal Register. Thereafter, DEA will revise this assessment at least once during the calendar year.

A. The assessment of annual needs for ephedrine, pseudoephedrine and phenylpropanolamine must be finalized prior to DEA issuing individual import, manufacturing and procurement quotas.

A. DEA will not issue individual import, manufacturing and procurement quotas to DEA-registered importers and manufacturers of ephedrine, pseudoephedrine, phenylpropanolamine, and the products derived therefrom, in 2007 after finalizing the 2007 assessment of annual needs. Rather, DEA will use this finalized assessment as the basis for proposing the establishment of the 2008 assessment of annual needs. DEA will seek comment on this proposed assessment and, as quotas are issued for a calendar year, will issue quotas for calendar year 2008.

However, DEA is requesting applications for individual quotas for the 2008 calendar year. Since the April 1 and May 1, 2007 deadline for 2008 import, manufacturing and procurement quotas has passed, DEA-registered importers and manufacturers of these chemicals, and drug products containing these chemicals, should submit applications as soon as possible so that individual quota applications may be processed prior to January 1, 2008.

A. An individual import quota represents the maximum amount of ephedrine, pseudoephedrine, and phenylpropanolamine that a DEA-registered importer is authorized to import in a calendar year.

A. Any person who imports ephedrine, pseudoephedrine or phenylpropanolamine, whether in bulk, in-process, or final dosage forms must apply for an individual import quota.

A. A separate import registration is not required so long as the registrant conducts the same activity with the listed chemical as is conducted with the controlled substance—that is, importation. DEA-registered importers of controlled substances whose registrations can be utilized to import listed chemicals pursuant to 21 CFR 1309.24(c) must identify the List I chemicals they handle as part of their controlled substances registration. Importers meeting this requirement should contact their local DEA office to request the addition to the controlled substances importer registration of the chemical codes for the chemicals handled. List I chemicals, and their chemical code numbers, are found at 21 CFR 1310.02.

A. DEA is soliciting applications for 2008 import quotas at this time; a DEA-registered importer does not need to obtain an import quota in 2007 prior to importing ephedrine, pseudoephedrine or phenylpropanolamine during the remainder of the 2007 calendar year.

A. Each DEA-registered importer that wishes to import ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived therefrom, must complete and file a DEA Form 488 each year for each chemical the importer wishes to import. Individual applications are required for importing either "bulk" chemical or finished dosage forms. The importer must provide on each application the following information:

• The type of product (bulk chemical or finished forms to be transferred to a manufacturer or product to be sold for distribution);
• The quantity of each type of product; and
• For the previous two years:
  • the name, address and DEA registration number (if applicable) of each customer and the amount sold;
  • inventory as of December 31 for each form of the product (i.e., bulk chemical, in-process material, or finished dosage form); and
  • acquisitions (imports)

A. Registrants are required to submit a completed Form 488, Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine, for DEA to process each individual request. However, certain quota requests might require additional information to be processed such as product development requirements or unknown requirements necessary to complete bona fide scientific research/clinical trials. DEA has significant expertise regarding the processing of these types of quota applications for manufacturers of controlled substances in Schedules I and II and will work with quota applicants to obtain information necessary to process these types of quota requests.

A. Applications for individual import quotas are due by April 1 of the year preceding the year for which the quota is being applied. Therefore, applications for 2008 import quotas were due to DEA by April 1, 2007. Applicants that have not filed 2008 applications should submit applications as soon as possible so applications can be considered and individual import quotas processed prior to January 1, 2008. Applications should be sent to the following address:

DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152

A. Initial 2008 import quotas will be issued in December 2007. Applications for adjustments to individual 2008 import quotas which are received during the 2008 calendar year must be approved or denied within 60 days of receiving a completed request for such adjustment, otherwise the request is deemed approved (21 CFR 1315.36).

A. Effective January 1, 2008, DEA-registered importers must have an import quota issued by DEA prior to submitting a DEA-486 to DEA for the importation of ephedrine, pseudoephedrine, phenylpropanolamine or the products derived therefrom.

A. Applications for adjustments to an individual import quota which are received during the calendar year must be denied by DEA within 60 days of receiving a completed request for such adjustment, otherwise the request is deemed approved (21 CFR 1315.36).

A. The importer will not receive a credit for its import quota. However, a return to an overseas supplier could form the basis for a request to adjust (increase) an individual import quota. Requests for adjustments may be made at anytime during the year.

A. Import quotas are issued on a calendar year basis and can only be used during the calendar year for which they were issued. If a DEA-registered importer wishes to import ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived therefrom in 2009, then the importer must submit a DEA Form 488 by the April 1, 2008, deadline.

A. The DEA importer registrant must have an individual import quota on the date that the in-transit shipment arrives in the United States, as noted in Section 4b of the registrant’s DEA Form-486, "Import/Export Declaration for List I and List II Chemicals" filed with the DEA pursuant to 21 CFR 1313.

A. An individual manufacturing quota represents the maximum amount of ephedrine, pseudoephedrine, and phenylpropanolamine a DEA registrant is authorized to bulk manufacture in a calendar year.

A. Only DEA-registered bulk manufacturers will be eligible to apply for individual manufacturing quotas. The term "manufacture" is defined in the CSA as "the production, preparation, propagation, compounding, or processing of a drug or other substance, … and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice." [21 U.S.C. 802(15)]

A. DEA is soliciting applications for 2008 manufacturing quotas at this time; a DEA-registered bulk manufacturer does not need to obtain a manufacturing quota prior to bulk manufacturing ephedrine, pseudoephedrine or phenylpropanolamine during the remainder of the 2007 calendar year.

A. Each DEA-registered bulk manufacturer, i.e., a manufacturer that wishes to produce bulk ephedrine, pseudoephedrine or phenylpropanolamine via extraction or chemical synthesis, must complete and file a DEA Form 189 if the manufacturer plans to bulk manufacture one of these chemicals beginning January 1, 2008. The applicant must provide the following information on its application:

• For the current and preceding two years:
  • the actual quantity manufactured,
  • actual net disposals, and
  • actual inventory as of December 31 of each year; and
• For the year for which quota is being applied:
  • the desired quota,
  • the name and registration number of each customer and the amount estimated to be sold to each, and
  • any additional factors the applicant finds relevant to fixing the quota.

A. Registrants are required to submit a completed Form 189 application in order for DEA to process each individual request. However, certain quota requests might require additional information to be processed such as product development requirements or unknown requirements necessary to complete scale-up batches for FDA requirements. DEA has significant expertise regarding the processing of these types of quota applications for manufacturers of controlled substances in Schedules I and II and will work with quota applicants to obtain information necessary to process these types of quota requests.

A. Applications for individual manufacturing quotas are due by May 1 of the year preceding the year for which the quota is being applied. Therefore, applications for 2008 manufacturing quotas were due to the DEA by May 1, 2007. Applicants that have not filed 2008 applications should submit applications as soon as possible so applications can be considered and individual manufacturing quotas processed prior to January 1, 2008. Applications should be sent to the following address:

DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152

A. Initial 2008 manufacturing quotas will be issued in December 2007. Applications for adjustments in an individual’s 2008 manufacturing quota which are received during the 2008 calendar year will be processed on a "first come, first served" basis.

A. Requests for adjustments in manufacturing quotas can be made at any time so long as information supporting the need for the increase is also provided.

A. The manufacturer will not receive a credit for its manufacturing quota. However, a return from a manufacturer’s customer could form the basis for a request to adjust (increase) a DEA registrant’s individual manufacturing quota if that material could not be salvaged or reworked into a saleable product.

A. Manufacturing quotas are issued on a calendar year basis and can only be used during the calendar year for which they were issued. If a DEA-registered bulk manufacturer wishes to bulk manufacture ephedrine, pseudoephedrine, or phenylpropanolamine in 2009, then the manufacturer must submit a DEA Form 189 by the May 1, 2008, deadline.

A. As of January 1, 2008, DEA-registered bulk manufacturers of ephedrine, pseudoephedrine, and phenylpropanolamine must obtain an individual manufacturing quota before bulk manufacturing of the substance may commence.

A. An individual procurement quota represents the maximum amount or quantity of ephedrine, pseudoephedrine, and phenylpropanolamine that a DEA-registered manufacturer is authorized to acquire or procure in a calendar year. A procurement quota authorizes a DEA-registered manufacturer to procure and use quantities of each chemical for the purpose of manufacturing such chemical into dosage forms or into other substances.

A. Only DEA-registered manufacturers will be eligible to apply for individual procurement quotas. The term "manufacture" is defined in the CSA as "the production, preparation, propagation, compounding, or processing of a drug or other substance, … and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice." [21 U.S.C. 802(15)

A. A DEA-registered manufacturer of controlled substances whose requirement of registration has been waived for the manufacture of products containing ephedrine, pseudoephedrine or phenylpropanolamine pursuant to 21 CFR 1309.24(b) must obtain a manufacturing quota. However, a separate chemical manufacturing registration is not required to apply for a manufacturing quota. As quota may be issued only to DEA-registered manufacturers, the person must be registered with DEA to manufacture either controlled substances or List I chemicals. Manufacturers meeting this requirement should contact their local DEA office to request the addition to the controlled substances manufacturer registration of the chemical codes for the chemicals handled. List I chemicals, and their chemical code numbers, are found at 21 CFR 1310.02.

A. A DEA-registered manufacturer of controlled substances whose requirement of registration has been waived for the manufacture of prescription drug products containing ephedrine, pseudoephedrine or phenylpropanolamine, must obtain a procurement quota. As quota may be issued only to DEA-registered manufacturers, the person must be registered with DEA to manufacture either controlled substances or List I chemicals. These registrants must identify the chemicals they manufacture as part of their controlled substances registration. Manufacturers meeting this requirement should contact their local DEA office to request the addition to the controlled substances manufacturer registration of the chemical codes for the chemicals handled. List I chemicals, and their chemical code numbers, are found at 21 CFR 1310.02.

A. Ephedrine, pseudoephedrine, and phenylpropanolamine which are to be used in manufacturing processes are obtained only after the issuance of quota. As DEA may only provide quota to registered manufacturers for the purposes of manufacturing, those who procure ephedrine, pseudoephedrine and phenylpropanolamine solely for internal consumption must obtain a chemical manufacturing registration from DEA for this purpose.

A. As of January 1, 2008, DEA-registered manufacturers as well as those persons originally waived from the registration requirements pursuant to 21 CFR 1309.24(h) must obtain an individual procurement quota before procuring ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived therefrom.

A. DEA is soliciting applications for 2008 procurement quotas at this time; a DEA-registered manufacturer does not need to obtain a procurement quota prior to manufacturing dosage form ephedrine, pseudoephedrine or phenylpropanolamine, or packaging, repackaging, labeling, or relabeling dosage form ephedrine, pseudoephedrine, or phenylpropanolamine during the remainder of the 2007 calendar year.

A. Each DEA-registered manufacturer that wishes to procure ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived therefrom, for the purpose of conducting dosage form manufacturing, packaging, labeling, repackaging or relabeling, must complete and file a DEA Form 250. The applicant must provide the following information:

• A statement about the purpose(s) of the requested chemical and the quantity which will be used for each purpose during the next calendar year.
• For the current and preceding two years:
  • the actual quantity manufactured,
  • actual net disposals, and
  • actual inventory as of December 31 of each year; and
• If the purpose is to manufacture dosage forms, the applicant must state the official name, common or usual name, chemical name, or brand name of that dosage form, and must include the strength;
• The applicant must state the type of activity intended: product development, repackaging, relabeling, manufacturing scheduled listed chemical finished products, manufacturing prescription finished product; and
• If the purpose is to manufacture a controlled substance listed in Schedule I or II or another List I chemical, the applicant must state the quantity of the other substance or chemical that the applicant has applied to manufacture under § 1303.22 and the quantity of the first chemical needed to manufacture a specified unit of the second chemical.

A. Registrants are required to submit a completed Form 250, Application for Procurement Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine, for DEA to process each individual request. However, certain quota requests might require additional information to be processed such as product development requirements or unknown requirements necessary to complete scale-up batches for FDA requirements. DEA has significant expertise regarding the processing of these types of quota applications for manufacturers of controlled substances in Schedules I and II and will work with quota applicants to obtain information necessary to process these types of quota requests.

A. Applications for individual procurement quotas are due by April 1 of the year preceding the year for which the quota is being applied. Therefore, applications for 2008 procurement quotas were due to DEA by April 1, 2007. Applicants that have not filed 2008 applications should submit applications as soon as possible so applications can be considered and individual procurement quotas processed prior to January 1, 2008. Applications should be sent to the following address:

DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152

A. Initial 2008 procurement quotas will be issued in December 2007. Applications for adjustments in an individual’s 2008 procurement quota which are received during the 2008 calendar year will be processed on a "first come, first served" basis.

A. Requests for adjustments in procurement quotas can be made at any time so long as information supporting the need for the increase is also provided.

A. The manufacturer will not receive a credit for its procurement quota. However, such a return could form the basis for a request to adjust (increase) a DEA registrant’s individual procurement quota.

A. Procurement quotas are issued on a calendar year basis and can only be used to procure ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived therefrom during the calendar year for which the quota was issued. If a DEA-registered manufacturer wishes to procure ephedrine, pseudoephedrine, phenylpropanolamine, or the products derived there from in 2009, then the DEA-registered manufacturer must submit a DEA Form 250 by the April 1, 2008, deadline.

A. As of January 1, 2008, a DEA-registered manufacturer of ephedrine, pseudoephedrine, phenylpropanolamine, and the products derived therefrom, must obtain an individual procurement quota before procuring any of these chemicals for dosage form manufacturing, packaging, repackaging, labeling and relabeling activities.