Controlled substances and listed chemicals
- Document symbol
- G/LIC/N/3/USA/21
- Original language
- English
- Published on
- 16/10/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The system of import permits, declarations, notices, and quotas is designed to restrict the importation of controlled substances and listed chemicals to that quantity necessary to meet the medical, scientific, or other legitimate needs of the United States, and to monitor the handlers of such substances. The system also establishes a method by which the United States can meet its international treaty obligations under the 1961 UN Single Convention on Narcotic Drugs, the 1971 UN Convention on Psychotropic Substances, and the 1988 UN Convention Against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
The Drug Enforcement Administration (DEA) serves as the United States competent authority for the regulatory provisions associated with the above three international conventions and is responsible for collecting data and preparing standard yearly statistical reports regarding the manufacture, import/export, and consumption of drugs and chemicals regulated by the conventions.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
In order to import any controlled substance, or List I chemical (including any drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine), the importer must apply to the DEA for registration as an importer. The registration application must be approved by the DEA and is issued annually. Prior to each importation of a controlled substance, List I chemical, or List II chemical, the importer must:
(a) Apply for and receive a permit to import any Schedule I or Schedule II controlled substance, or any narcotic controlled substance in Schedules III, IV, or V or any non-narcotic controlled substance in Schedule III which the Administrator has specifically designated by regulation in Title 21, Code of Federal Regulations, Section 1312.30 or any non-narcotic controlled substance in Schedule IV or V which is also listed in Schedule I or II of the Convention on Psychotropic Substances; or
(b) Submit an import declaration not later than 15 days in advance for any non-narcotic controlled substances in Schedules III, IV, or V, excluding those described in paragraph (a) above. (The list of basic classes of controlled substances covered under the authority of the Controlled Substances Act is listed in Title 21, Code of Federal Regulations, Part 1308); or
(c) Submit an import declaration not later than 15 days in advance for any listed chemical that meets or exceeds the threshold quantities set by regulation or is a listed chemical for which no threshold has been established. Substances defined as listed chemicals under the authority of the Controlled Substances Act, and their thresholds, are contained in Title 21, Code of Federal Regulations, Part 1310. Advanced notice may be waived under certain circumstances as outlined in Title 21, Code of Federal Regulations, Section 1313.12(c).
Crude opium, poppy straw, concentrate of poppy straw or coca leaves may be imported in such amounts as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes. Title 21 United States Code, Section 952(a)(1). Controlled substances in Schedule I or II, and narcotic substances in Schedule III, IV or V, may be imported if the Attorney General finds it to be necessary to provide for the medical, scientific, or other legitimate needs of the United States (a) during an emergency in which domestic supplies are found by the Attorney General to be inadequate; (b) in any case in which the Attorney General finds that competition among domestic manufacturers is inadequate and will not be rendered adequate by the registration of additional manufacturers; or (c) in any case in which the Attorney General finds that such controlled substance is in limited quantities exclusively for scientific, analytical, or research uses. Title 21 United States Code, Section 952 (a)(2).
Q3. The system applies to goods originating in and coming from which countries?
In general, the import permit or declaration requirement applies to controlled substances and listed chemicals, regardless of the country of origin. However, Title 21, Code of Federal Regulations, Section 1312.13 poses additional limitations on the imports of narcotic raw materials. In effect, the importation of approved narcotic raw materials (opium, poppy straw and concentrate of poppy straw) into the United States shall have as its source:
(a) Turkey, (b) India, (c) Spain, (d) France, (e) Poland, (f) Hungary, and (g) Australia.
and, at least 80% of the narcotic raw material imported into the United States shall have as its source Turkey and India. Except under conditions of insufficient supplies of narcotic raw materials, not more than 20% of the narcotic materials imported annually shall originate in Spain, France, Poland, Hungary, and Australia.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The system is designed to restrict the quantity of imports of controlled substances and listed chemicals (not monetary value) and to maintain a monitoring system. Previous systems were used prior to the import requirements of the Controlled Substances Act (effective 1 May 1971). However, the current system is mandated by United States law and, as far as controlled substances are concerned, is based upon two international treaties (The Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971).
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
In March 2006, the United States Congress amended the Controlled Substances Act with passage of the Combat Methamphetamine Epidemic Act of 2005 (CMEA). The CMEA required the establishment of an assessment of annual need for the listed chemicals ephedrine, pseudoephedrine, and phenylpropanolamine and a quota system to provide for those legitimate needs. Further, the CMEA amended Title 21, United States Code, Section 952 by adding those three specific List I chemicals (ephedrine, pseudoephedrine, and phenylpropanolamine) to existing language concerning importation of controlled substances. Each year, DEA's published assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine set upper limits on the quantity of these listed chemicals and products containing these chemicals that can be produced in or imported to the United States for that calendar year. Each annual assessment is published as a Final Notice in the Federal Register. Also pursuant to the CMEA, DEA set in place a process for registered (licensed) firms to obtain individual import and production quota amounts.
The system of registration of importers and the system of quotas (for Schedule I and II drugs) are statutory requirements established in the Comprehensive Drug Abuse Prevention and Control Act of 1970, Part C (Sections 301, 302, 303, 306) and the import requirements established in the Controlled Substances Import and Export Act (Sections 1002, 1007 and 1008) (21 United States Code, Sections 822, 823, 826, 952, 953, 957 and 958) and implementing regulations. The Controlled Substances Act established criteria by which drugs are controlled in one of five schedules subject to import requirements. The system required by statute cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Annual notice of aggregate production quotas and assessments of annual needs designed to account for all Schedule I and II controlled substances and the listed chemicals ephedrine, pseudoephedrine, and phenylpropanolamine are published in the Federal Register before 1 December of the year prior to that to which the quota applies. No quota is established for Schedules III, IV or V controlled substances or other listed chemicals. Additional notice of regulations is published in Title 21, Code of Federal Regulations, Parts 1300 to 1399.
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Assessments, estimates, and quotas for legitimate need are determined on an annual basis, but determinations regarding importations are made at the time of individual applications.
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Import permits are issued pursuant to applications by registered importers who have demonstrated the medical, scientific, or other legitimate need for the imported substance. Declarations and notices are submitted as advanced notification of import only for monitoring purposes by the DEA.
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Not applicable; individual determinations are made.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Applications to import permits are reviewed upon receipt by the DEA.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Applications to import permits are reviewed upon receipt by the DEA.
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
The DEA considers and reviews for possible approval, all applications for importation of controlled substances. Copies of import permits are provided to United States Customs and Border Protection for monitoring and certification purposes.
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
The DEA utilizes the International Import and Export Authorization System (I2ES), an online platform developed by the International Narcotic Control Board with the support of the United Nations Office on Drugs and Crime, to issue electronic import and export authorizations for narcotic drugs and psychotropic substances in compliance with the international drug control treaties. I2ES equips Governments with a paperless system that supports the issuance and exchange of electronic import and export authorizations for controlled substances to expedite communication among Governments and reduce the dependency on postal services because import and export authorizations are available online.
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
The DEA utilizes the International Import and Export Authorization System (I2ES), an online platform developed by the International Narcotic Control Board with the support of the United Nations Office on Drugs and Crime, to issue electronic import and export authorizations for narcotic drugs and psychotropic substances in compliance with the international drug control treaties. I2ES equips Governments with a paperless system that supports the issuance and exchange of electronic import and export authorizations for controlled substances to expedite communication among Governments and reduce the dependency on postal services because import and export authorizations are available online.
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Controlled substances on permits may only be imported for legitimate needs of the United States.
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Schedules III, IV, and V non-narcotic controlled substances are subject to import declarations, and importers are subject to registration with the DEA.
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Importation may be made only by approved, registered importers. An import declaration must be filed 15 days in advance of the proposed date of import. In special circumstances, the 15 days may be waived administratively.
Q7.b. Can a licence be granted immediately on request?
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Yes. The DEA.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
A registered importer can be refused an importation if the importer cannot demonstrate the legitimate need in the United States, in line with the above criteria.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Imports of controlled substances and List I chemicals are only approved for the DEA registered importers who must be inspected for adequate records, security, state approval, etc., prior to registration with the DEA. Importers of List II chemicals are not subject to DEA registration requirements but are considered “regulated persons” subject to recordkeeping and reporting requirements.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The information required for an import permit is set forth in Title 21, Code of Federal Regulations, Section 1312.12 and includes: (a) name, address, and business of consignor; (b) foreign port and country of initial export; (c) United States port of entry; (d) the latest date shipment will leave a foreign port; (e) stock on hand of the controlled substance desired to be imported; (f) name of carrier or vessel ; (g) tentative total allotment to the importer of such controlled substances for the current calendar year; and (h) the total number of kilograms of said allotment for which permits have previously been issued and the total quantity of controlled substance actually imported during the current year to date.
Q11. What documents are required upon actual importation?
Import permit.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No fee is levied per import permit. Registration fees are as follows:
| Registrant Class | Annual Fee (As of 1 October 2020) |
|---|---|
| Importers/Exporters (Controlled Substances) | $1,850 |
| Importers/Exporters (Chemical) | $1,850 |
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
Registration with the DEA as an importer is annual. Controlled Substance import permits are not valid after the date specified in permit, and in no event shall the date be later than six months after the date the permit is issued.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
Importation of a controlled substance or listed chemical which is made without a valid permit, notice, or declaration is subject to seizure and civil or criminal penalties.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
No.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.