Source: https://www.federalregister.gov/documents/2008/01/18/E8-774/registration-requirements-for-importers-and-manufacturers-of-prescription-drug-products-containing
Timestamp: 2018-09-22 20:57:07
Document Index: 41528653

Matched Legal Cases: ['ART 1309', 'arts 1300', '§\u20091309', '§\u20091309', '§\u20091300', '§\u20091300', '§\u20091309', 'art 1310', '§\u20091309', '§\u20091301', '§\u20091309', '§\u20091300', '§\u20091300', '§\u20093', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091300', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091300', '§\u20091300', '§\u20091300', '§\u20091309', '§\u20091309', '§\u20091309', '§\u20091309', 'arts 1310', '§\u20091309']

Federal Register :: Registration Requirements for Importers and Manufacturers of Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine
A Proposed Rule by the Drug Enforcement Administration on 01/18/2008
Written comments must be postmarked, and electronic comments must be sent, on or before March 18, 2008.
73 FR 3432
3432-3441 (10 pages)
21 CFR 1309
Docket No. DEA-294P
1117-AB09
E8-774
PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
https://www.federalregister.gov/d/E8-774 https://www.federalregister.gov/d/E8-774
The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which was enacted on March 9, 2006, requires DEA to establish an assessment of annual need for the importation and manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine. Because of the new CMEA mandates for importation, import quotas, and production quotas for these chemicals, DEA must revise its registration provisions. The changes made by the CMEA render current DEA regulations inadequate for two reasons. First, although DEA registers bulk manufacturers of the three chemicals in the United States and importers of the bulk chemicals, some of those chemicals are distributed to non-registered companies that process them into prescription drugs. Under the Controlled Substances Act, section 826, production quotas are available only to registered manufacturers. DEA cannot meet the CMEA mandate to establish annual need and import quotas, and then issue individual quotas for each of the chemicals unless all manufacturers manufacturing or procuring the chemicals and manufacturing drug products that contain the chemicals are registered as manufacturers, even if the distribution of the final drug products is not regulated. DEA also must know the quantity of prescription drug products containing the three chemicals being imported. Without this information, DEA would not be able to determine an assessment of annual need for these chemicals. Any person importing prescription drug products containing any of the three chemicals must register although the distribution of these products would not be subject to DEA regulation.
Accordingly, DEA is proposing to amend its registration regulations to ensure that every location that manufactures or imports one of these chemicals or drug products that contain ephedrine, pseudoephedrine, or phenylpropanolamine is a DEA registered manufacturer or importer. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the manufacturing that Congress Start Printed Page 3433mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.
To ensure proper handling of comments, please reference “Docket No. DEA-204” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here.
Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington DC 20537 at (202) 307-7297.
DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, and industrial purposes and to deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA as amended also requires DEA to regulate the manufacture, distribution, import, and export of chemicals that may be used to manufacture controlled substances illegally. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances.
CMEA amended the CSA to include ephedrine, pseudoephedrine, and phenylpropanolamine in 21 U.S.C. 826 (Production quotas for controlled substances) and section 952(a) (Importation of controlled substances). Congress essentially imposed the same requirements for importation of ephedrine, pseudoephedrine, and phenylpropanolamine as are imposed on narcotic raw materials—crude opium, poppy straw, concentrate of poppy straw, and coca leaves. That is, imports of ephedrine, pseudoephedrine, and phenylpropanolamine are prohibited except for such amounts as the Attorney General (DEA by delegation) finds to be necessary to provide for medical, scientific, or other legitimate purposes. Congress also imposed the same requirements on the manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine as are established for Schedule I and II controlled substances. That is, Congress mandated the establishment of a total need for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each 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. These requirements apply equally to products containing these three List I chemicals as they do to the List I chemicals themselves.
Controlled substances are subject to a closed system of controls that ensures that no person may manufacture, distribute, import, export, or dispense unless that person is a DEA registrant, or exempted from the requirement of registration. Production of Schedule I and II controlled substances is limited to the quantity that DEA has determined is required to meet the legitimate medical, scientific, research, and industrial needs of the United States; for Start Printed Page 3434lawful export requirements; and for establishment and maintenance of reserve stocks (21 U.S.C. 826(a)). After DEA establishes the total annual need, DEA issues individual manufacturing and procurement quotas to manufacturers; under section 826, quotas may be issued only to registered manufacturers. Manufacturers may not produce or purchase more of a substance than is available under their individual quotas. Under the CSA, “manufacture” is defined to include all of the following:
DEA, in 1995, first imposed registration requirements on firms that manufacture, distribute, import, and export List I chemicals. Although section 822 of the CSA states that any person who manufactures or distributes a controlled substance or List I chemical must register with DEA, DEA limited chemical registration for manufacturers to firms that manufacture to distribute List I chemicals. Some manufacturers were not required to register under the “manufacture for distribution” policy. Those that manufactured and chemically consumed and transformed all of the chemical in their own processes; those that purchased List I chemicals in bulk and manufactured prescription drug products that contain a List I chemical; and those that repackaged or relabeled prescription drug products that contain a List I chemical were not required to obtain a DEA chemical registration. Firms that manufacture a List I chemical in bulk and distribute to wholesalers or to other manufacturers were already required to register and file reports with DEA. Firms that manufacture scheduled listed chemical products (nonprescription/OTC drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine) also distribute those products, were already required to obtain a DEA chemical registration.
As a consequence of the “manufacture for distribution” policy, firms that manufactured prescription drugs containing ephedrine, pseudoephedrine, and phenylpropanolamine were not required to register because distributions of the prescription drug products were not regulated. DEA, in § 1309.22, listed only four activities involving List I chemicals that required registration: Retail distributing, non-retail distributing, importing, and exporting. On the application for registration form, firms were required to indicate whether they were seeking to be registered as manufacturers or distributors (e.g., wholesalers), but the regulation did not distinguish between those who manufacture to distribute and those who simply distribute. In addition, in § 1309.24, DEA waived the chemical distribution registration requirement for firms that manufacture or distribute drug products lawfully marketed under the FFD&CA containing the three chemicals for any firm that is registered to manufacture, distribute, or dispense a controlled substance. Note that this waiver (from the requirement to obtain a separate DEA chemical registration) was only provided for drug products containing a listed chemical which is in final packaged/labeled form which is lawfully marketed under the FFD&CA. Drug products not in final packaged/labeled form were not provided this waiver. For example, an importer of bulk tablets containing a listed chemical, intended for a drug product marketed in the United States, would still have to obtain a chemical importer registration, and would not be able to use their controlled substance registration for such activity.
Because of the new CMEA mandates for importation, import quotas, and production quotas for these chemicals, DEA is proposing to revise its registration provisions. The changes made by the CMEA render current DEA regulations inadequate for two reasons. First, although DEA registers bulk manufacturers of the three chemicals in the United States and importers of the bulk chemicals, some of those chemicals are distributed to non-registered companies that process them into prescription drugs. Under the CSA section 826, production quotas are available only to registered manufacturers. DEA cannot meet the CMEA mandate to establish an annual need and import quotas, and then issue individual quotas for each of the chemicals unless all manufacturers manufacturing or procuring the chemicals and manufacturing drug products that contain the chemicals are registered as manufacturers, even if the distribution of the final drug products is not regulated. DEA also must know the quantity of prescription drug products containing the three chemicals being Start Printed Page 3435imported; without this information, DEA would not be able to determine an assessment of annual need for the chemicals. Any person importing prescription drug products containing any of the three chemicals must register although the distribution of these products would not be subject to DEA regulation.
The second inadequacy is that the existing language allows a controlled substance distributor or dispenser to avoid registration as a chemical manufacturer if they manufacture scheduled listed chemical products or other products containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D). (DEA notes that there may be a limited number of drug products containing List I chemicals other than ephedrine, pseudoephedrine, and phenylpropanolamine which meet this description.) This provision must also be changed so that controlled substance registrants will not need to obtain a chemical registration only if they engage in the same activity for both drug products containing List I chemicals and controlled substances as is already the case for bulk manufacture, imports, and exports. In this way, any registrant that must obtain a quota to manufacture or procure one or more of the chemicals will be a registered manufacturer, as required by the CSA.
As noted above, the CSA defines the term “manufacture” to include the physical manufacture of a chemical or product, as well as the packaging, labeling, repackaging, and relabeling of that product (21 U.S.C. 802(15)).
All bulk manufacturers of List I chemicals must register unless all of the chemical produced is consumed internally and is not available for use in products No change.
Manufacturers of scheduled listed chemical products register if distribute Manufacturers of prescription products ** containing List I chemicals do not register. All manufacturers of drug products containing List I chemicals * would register.
Distributors of List I chemicals and scheduled listed chemical products register Distributors of prescription products ** containing List I chemicals do not register. No change.
Importers of List I chemicals and scheduled listed chemical products register Importers of prescription products ** containing List I chemicals do not register. Importers of List I chemicals and all drug products containing List I chemicals * would register.
Start Printed Page 3436
Exporters of List I chemicals and scheduled listed chemical products register Exporters of prescription products ** containing List I chemicals do not register. No change.
Manufacturers of both controlled substances and drug products containing List I chemicals may register as only controlled substance manufacturers No change.
Manufacturers of drug products containing any List I chemical * who distribute or dispense controlled substances may register for only their controlled substance activity. A separate registration for the chemical activity is permissible Manufacturers of drug products containing any List I chemical * would register as manufacturers. If they distribute or dispense controlled substances they would register separately for those activities.
Distributors of both controlled substances and drug products containing List I chemicals may register as only controlled substance distributors No change.
Importers of both controlled substances and drug products containing List I chemicals register as controlled substance importers No change.
Exporters of both controlled substances and drug products containing List I chemicals register as controlled substance exporters No change.
Manufacturers, distributors, importers, and exporters of bulk List I chemicals register, regardless of whether they handle controlled substances No change.
* “Drug products containing List I chemicals” refers to scheduled listed chemical products or other products containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D). Such drug products must be in packaged/labeled form as required under the FFD&CA for lawful marketing.
** “Prescription products,” for purposes of this chart, refers to “any transaction in a List I chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act * * *” (21 U.S.C. 802(39)(a)(iv)). To comply with the marketing and distribution requirements of the Federal Food, Drug, and Cosmetic Act for prescription drugs, such drugs must be packaged and labeled in accordance with the Federal Food, Drug and Cosmetic Act as prescription drugs.
As a result of the change, any person manufacturing or importing a prescription drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine would become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons who would be newly subject to the registration requirement to complete and submit an application for registration and for DEA to issue registrations for those activities immediately. Therefore, to allow continued legitimate commerce, DEA is proposing to establish in § 1309.25 a temporary exemption from the registration requirement for persons desiring to engage in manufacturing or importing prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine, provided that DEA receives a properly completed application for registration on or before 30 days from the date of publication of a Final Rule in the Federal Register. The temporary exemption for such persons will remain in effect until DEA takes final action on their application for registration.
Records and Reports. The CSA (21 U.S.C. 830) requires certain records to be kept and reports to be made involving listed chemicals. Regulations describing recordkeeping and reporting Start Printed Page 3437requirements are set forth in 21 CFR part 1310. A record must be made and maintained for two years after the date of a regulated transaction involving a List I chemical. Each regulated bulk manufacturer of a regulated mixture must submit manufacturing, inventory, and use data on an annual basis (21 CFR 1310.05(d)). Bulk manufacturers producing the chemicals solely for internal consumption are not required to submit this information; internal consumption does not include using the chemical to produce drug products. Existing standard industry reports containing the required information are acceptable, provided the information is readily retrievable from the report.
DEA is proposing to amend §§ 1309.11 and 1309.12 to replace “manufacture for distribution” with “manufacture.” In addition, in both sections, DEA is proposing to remove references to retail distributors. In amendments to 21 U.S.C. 823(h) the CMEA expressly stated that distributors of scheduled listed chemical products at retail are not required to register under the Controlled Substances Act. To avoid confusion, DEA decided to address all registration revisions related to CMEA implementation in this rulemaking.
Section 1309.21 is proposed to be revised to state that every person who manufactures or proposes to manufacture a List I chemical or a drug product containing a List I chemical must register. The change would require manufacturers of prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine to register even though they are not required to register to distribute or export the products. DEA is also proposing to add a table to the section, similar to the table in § 1301.13 on controlled substance registration requirements, to summarize the requirements for each business activity. As discussed above, this revision would not alter the registration requirements for bulk manufacturers of List I chemicals and for manufacturers of scheduled listed chemical products.
In § 1309.24 paragraph (b) is proposed to be revised to clarify that a person who manufactures or distributes a scheduled listed chemical product or other product containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D) is exempted from registration only if registered to conduct the same activity with controlled substances. Paragraph (c) is proposed to be revised to clarify that a person who imports or exports a scheduled listed chemical product or other product containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D) is exempted from registration only if registered to conduct the same activity with controlled substances. Paragraph (e) waiving registration for retail distributors is proposed to be removed because CMEA statutorily does not require them to register. The remaining paragraphs (f) through (l) would be redesignated (e) through (k). DEA notes that the waiver of the requirement of registration continues for bulk manufacturers who manufacture and consume all of the List I chemical internally.
This rule proposes to codify provisions necessary for implementation of the Combat Methamphetamine Epidemic Act. As discussed further below, DEA has examined the potential impacts of this rule. DEA has no basis for estimating the number of firms that may be small, but given the definition of small entities, it is likely that a substantial number of the new registrants will be small. The cost of compliance, however, would not impose a significant economic burden. The only cost is the $2,293 registration fee for manufacturers, and the $1,147 registration fee for importers, respectively. The recordkeeping and reporting requirements can be met using existing business and manufacturing records. The security provisions are general and require the registrant to provide effective controls and procedures to guard against theft and and diversion of List I chemicals. Any Start Printed Page 3438manufacturer approved by the FDA and complying with good manufacturing practices or currently registered to handle controlled substances will have internal controls that meet this requirement. The smallest pharmaceutical firms (with 1 to 4 employees) had an average value of shipments of $824,000 in 2002 ($886,000 in 2007 dollars, based on GDP). Even for these firms, which are unlikely to be producing the covered drug products, the $2,293 registration fee would represent less than 0.3 percent of sales and, therefore, is not a significant burden. Therefore, this rule will not have a significant economic impact on a substantial number of small entities.
The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 section 1(b). It has been determined that this is “a significant regulatory action.” Therefore, this action has been reviewed by the Office of Management and Budget. As discussed above, this action is necessary to implement statutory provisions. DEA has, nonetheless, reviewed the potential costs.
This Notice of Proposed Rulemaking would require that certain persons who were not previously registered with DEA obtain a registration to handle the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Specifically, persons manufacturing prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine were not previously required to register, but now would be required to obtain a registration so that they may be eligible to apply for individual quotas for these List I chemicals. Additionally, importers of prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine who were not previously registered as List I chemical importers would be required to register so that they may be eligible to apply for import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. DEA estimates that approximately 200 firms may have to obtain a new DEA registration. DEA assumes that these firms complete the registration application electronically, with each application taking 15 minutes to complete. The receipt of these additional applications increases the hour burden by 50 hours annually. Therefore, DEA is proposing to revise an existing approved information collection, “Application for Registration under Domestic Chemical Diversion Control Act of 1993 and Renewal Application for Registration Under Domestic Chemical Diversion Control Act of 1993” (OMB # 1117-0031), to reflect the increase in population associated with this rule.
Further, DEA is proposing to amend the forms associated with the existing approved information collection “Application for Registration (DEA Form 225) and Application for Registration Renewal (DEA Form 225a)” (OMB # 1117-0012) to include a listing of all List I chemicals on the application forms. Currently, controlled substances registrant applicants, who use these forms to apply for DEA registration, are not required to identify the List I chemicals they handle. Without this identification, it is not possible for these persons to apply for individual quotas for these chemicals. The addition of the List I chemicals will allow persons to identify which chemicals they handle. New applicants would be required to identify the List I chemicals they handle upon their initial application; persons renewing their registration will identify the chemicals at the time of their renewal. This information must merely be verified for each succeeding renewal. Thus, the addition of this list will not have a measurable effect on the time needed to complete the application. Therefore, DEA is not proposing to revise the collection itself, but rather is proposing to make changes only to the application forms themselves.
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, Start Printed Page 3439including the validity of the methodology and assumptions used;
Form Number: DEA Forms 510 and 510a.
Other: Not-for-profit, government agencies.
Abstract: The Domestic Chemical Diversion Control Act requires that manufacturers, distributors, importers, and exporters of List I chemicals which may be diverted in the United States for the production of illicit drugs must register with DEA. Registration provides a system to aid in the tracking of the distribution of List I chemicals.
This regulation meets the applicable standards set forth in §§ 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Administrative practice and procedure; Drug traffic control; Exports; Imports; Security measures
§ 1309.11
§ 1309.12
Time and method of payment; refund.
(b) Payments should be made in the form of a credit card; a personal, certified, or cashier's check; or a money order made payable to “Drug Enforcement Administration.” Payments made in the form of stamps, foreign currency, or third party endorsed checks will not be accepted. These application fees are not refundable.
§ 1309.21
(a) Unless exempted by law or under §§ 1309.24 through 1309.26, the following persons must annually obtain a registration specific to the List I chemicals to be handled:
(2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under § 1300.02(b)(28)(i)(D) of this chapter.
(b) Only persons actually engaged in the activities are required to obtain a Start Printed Page 3440registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)
Manufacturing List I, Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine New—510 Renewal—510a $2,293 2,293 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Distributing List I, Scheduled listed chemical products New—510 Renewal—510a 1,147 1,147 1
Importing List I, Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine New—510 Renewal—510a 1,147 1,147 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Exporting List I, Scheduled listed chemical products New—510 Renewal—510a 1,147 1,147 1
§ 1309.22
Separate registration for independent activities.
(b) Except as provided in paragraphs (c) and (d) of this section, every person who engages in more than one group of independent activities must obtain a separate registration for each group of activities, unless otherwise exempted by the Act or §§ 1309.24 through 1309.26.
6. In § 1309.23 paragraph (a) is revised to read as follows:
§ 1309.23
Separate registration for separate locations.
§ 1309.24
Waiver of registration requirement for certain activities.
(b) The requirement of registration is waived for any person who manufactures or distributes a scheduled listed chemical product or other product containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D), if that person is registered with the Administration to engage in the same activity with a controlled substance.
(c) The requirement of registration is waived for any person who imports or exports a scheduled listed chemical product or other product containing a List I chemical that is described and included in the definition of “regulated transaction” in § 1300.02(b)(28)(i)(D), if that person is registered with the Administration to engage in the same activity with a controlled substance.
(d) The requirement of registration is waived for any person who only distributes a prescription drug product containing a List I chemical that is regulated pursuant to § 1300.02(b)(28)(i)(D) of this chapter.
(i) If any person exempted under paragraph (b), (c), (d), (e), or (f) of this section also engages in the distribution, importation, or exportation of a List I chemical, other than as described in such paragraph, the person shall obtain a registration for the activities, as required by § 1309.21 of this part. Start Printed Page 3441
(j) The Administrator may, upon finding that continuation of the waiver would not be in the public interest, suspend or revoke a waiver granted under paragraph (b), (c), (d), (e), or (f) of this section pursuant to the procedures set forth in §§ 1309.43 through 1309.46 and §§ 1309.51 through 1309.55 of this part. In considering the revocation or suspension of a person's waiver granted pursuant to paragraph (b) or (c) of this section, the Administrator shall also consider whether action to revoke or suspend the person's controlled substance registration pursuant to 21 U.S.C. 824 is warranted.
(k) Any person exempted from the registration requirement under this section must comply with the security requirements set forth in §§ 1309.71 through 1309.73 of this part and the recordkeeping and reporting requirements set forth under parts 1310 and 1313 of this chapter.
§ 1309.25
Temporary exemption from registration for chemical registration applicants.