DEA Finalizes Interim Rule that Established Import Quotas, Etc. for Three List I Chemicals (Including Ephedrine)

The final rule's one change from the interim final rule extends the authority to sign certifications of procurement quotas to persons granted power of attorney to do so by the registrant. (See below for details.)

Highlights of DEA Quota Procedures

The following are highlights of the amendments to 21 CFR Parts 1315 and 1300 that were implemented by the interim final rule, and that are now made final by this rule:

DEA issuance of import and procurement quotas. To track and control the quantity of each of the subject List I chemicals and drug products containing such chemicals, the DEA must limit imports to a quantity consistent with the national needs. In order to determine the estimated needs for and to ensure an adequate and uninterrupted supply of the subject List I chemicals, DEA will issue import (and procurement) quotas.

Registered importers must apply for import quotas. Any person who is registered to import the subject List I chemicals or whose requirement of registration is waived pursuant to 21 CFR 1309.24(c) and who desires to import the subject List I chemicals or drug products containing these chemicals during the next calendar year, must apply on DEA Form 488 for an import quota for the chemical.

Applications must include distribution/sales data, etc. Among other requirements, the application must include, for the current and preceding two calendar years, expressed in terms of base: (i) distribution/sales - name, address, and registration number (if applicable) of each customer and the amount sold; (ii) inventory as of December 31 (each form - bulk, in-process, finished dosage form); and (iii) acquisition -imports.

Quota quantities to reflect manufacturing needs, past imports, etc. On or before July 1 of the year preceding the calendar year during which the quota shall be effective, the DEA shall issue to each qualified applicant an import quota authorizing them to import (1) all quantities of the chemical necessary to manufacture products that registered manufacturers are authorized to manufacture pursuant to 21 CFR 1315.23 and (2) such other quantities of the chemical that the applicant has applied to import and that are consistent with their past imports, the estimated medical, scientific, and industrial needs of the U.S., the establishment and maintenance of reserve stocks, and the total quantity of the chemical that will be produced.

Importers can request quota changes. Any person to whom an import quota has been issued may at any time request an increase in the quota quantity by applying to the DEA with a statement showing the need for the adjustment. The DEA may increase the import quota of the person if and to the extent it determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical. The DEA shall specify a period of time for which the approval is in effect or shall provide that the approval is in effect until it notifies the applicant in writing that the approval is terminated.

The DEA is required to approve or deny the application within 60 days of receiving it, and if it does not do so, the application is deemed to be approved. Such an approval remains in effect until the DEA notifies the applicant in writing that it is terminated.

Procurement quota holders must certify that quantity ordered is within quota. Any person to whom a procurement quota² has been issued must certify in writing to the other registrant, at or before the time of placing an order with another manufacturer or importer requiring the distribution of a quantity of the chemical, that the quantity of the subject List I chemicals ordered does not exceed the person's unused and available procurement quota for the current calendar year.

(In addition, this rule makes final the interim rule's amendment to 21 CFR 3100.02 that added a reference to new 21 CFR Part 1315 in the definition for "regulated transaction.")

Final Rule Allows Those with Power of Attorney to Sign Certifications

In the final rule, DEA is revising the provision in 21 CFR 1315.32(h) regarding who may sign the required certification that an order is within the ordering company's quota.

According to DEA, this revision provides a benefit to registrants, permitting the signature of a certification for procurement quota to be by an individual authorized to sign the registration, or a person granted power of attorney to sign the certification.

To accomplish this, DEA is also adding a new 21 CFR 1315.33 to establish a process for granting and revoking power of attorney status; this section parallels the provisions of 21 CFR 1305.05.

¹In addition, the interim final rule made DEA's regulations consistent with the Combat Methamphetamine Epidemic Act of 2005 (CMEA), signed by the President on March 9, 2006, which mandated that DEA establish total annual requirements, and individual import, manufacturing, and procurement quotas for ephedrine, pseudoephedrine, and phenylpropanolamine.

²Any person who is registered to manufacture the subject List I chemicals or whose requirement of registration is waived pursuant to 21 CFR 1309.24 and who desires to use the subject List I chemicals during the next calendar year for purposes of manufacturing (including repackaging or relabeling), must apply for a procurement quota for the chemical. (See interim final rule for details about procurement quotas.)

(See ITT's Online Archives or 08/08/07 news, 07080820, for BP summary of the interim final rule.)

DEA contact - Christine Sannerud (202) 307-7183

DEA final rule (D/N DEA-293F, FR Pub 12/03/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-28651.pdf

DEA interim final rule (D/N DEA-293, FR Pub 07/10/07) available at http://edocket.access.gpo.gov/2007/pdf/E7-13377.pdf