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Chemical Handler's Manual

SECTION III – REGISTRATION REQUIREMENTS

Who Must Register

Information regarding general requirements of registration may be found at 21 U.S.C. §§ 822, 823, 824, 957, 958; and at 21 C.F.R. part 1309 and 21 C.F.R. §§ 1310.12 and 1310.13.

The following persons must annually obtain a DEA registration specific to the List I chemicals to be handled:

  1. Every person who manufactures or imports or proposes to manufacture* or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.
  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 paragraph (iv) of the definition of regulated transaction found at 21 C.F.R. § 1300.02(b).

(*See Section II, Definitions for a complete definition of manufacture.)

Only persons actually engaged in the activities are required to obtain a registration; 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.)

Persons who handle List II chemicals only are not required to register with the DEA; however, they are required to maintain records and file reports equivalent to the requirements explained elsewhere in this manual for List I chemical handlers.

Factors Used by the DEA in Approving List I Chemical Applications

Information regarding these factors may be found at 21 U.S.C. § 823(h).

  1. Maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;
  2. Compliance by the applicant with applicable Federal, State, and local law;
  3. Any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
  4. Any past experience of the applicant in the manufacture and distribution of chemicals; and
  5. Such other factors as are relevant to and consistent with the public health and safety.

Exceptions to Registration

There are waivers of registration requirements for certain activities, exemptions for law enforcement officials, an exemption for regulated sellers of scheduled listed chemical products (SLCP), and an exemption for mail-order distributors of SLCPs. These waivers and exemptions are explained in the succeeding paragraphs. There are also registration exemptions for handlers of certain chemical mixtures. A table of exempt chemical mixtures can be found in Appendix F. Appendix G provides four categories of chemical mixtures that are automatically exempt. Detailed information on chemical mixtures may be found in 21 C.F.R. §§ 1310.12 and 1310.13.

Waiver of Registration Requirement for Certain Activities

Information regarding these waivers may be found at 21 C.F.R. § 1309.24.

The following activities are deemed to be waived from the requirement of registration:

  1. Any agent or employee of a person who is registered to engage in any group of independent activities, if the agent or employee is acting in the usual course of his or her business or employment.
  2. Any person who manufactures or distributes an SLCP or other product containing a List I chemical that is described and included in paragraph (iv) of the definition of "regulated transaction" found at 21 C.F.R. § 1300.02(b), if that person is registered with the DEA to engage in the same activity with a controlled substance.
  3. Any person who imports or exports an SLCP or other product containing a List I chemical that is described and included in paragraph (iv) of the definition of "regulated transaction" found at 21 C.F.R. § 1300.02(b), if that person is registered with the DEA to engage in the same activity with a controlled substance.
  4. Any person who only distributes a prescription drug product containing a List I chemical that is regulated pursuant to paragraph (iv) of the definition of regulated transaction found at 21 C.F.R. § 1300.02(b).
  5. Any person whose activities with respect to List I chemicals are limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts) to another location operated by the same firm solely for internal end-use, or an EPA or State licensed waste treatment or disposal firm for waste disposal.
  6. Any person whose distribution of red phosphorus or white phosphorus is limited solely to residual quantities of chemical returned to the producer, in reusable rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2,500 gallons in a single container).
  7. Any person whose activities with respect to List I chemicals are limited solely to the distribution of Lugol's Solution (consisting of 5 percent iodine and 10 percent potassium iodide in an aqueous solution) in original manufacturer's packaging of one fluid ounce (30 ml) or less.
  8. Any manufacturer of a List I chemical, if that chemical is produced solely for internal consumption by the manufacturer and there is no subsequent distribution or exportation of the List I chemical.

If any person exempted under paragraphs 2, 3, 4, 5, or 6 above 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.

The DEA may, upon finding that continuation of the waiver would not be in the public interest, suspend or revoke a waiver granted under paragraphs 2, 3, 4, 5, or 6 above pursuant to the procedures set forth in 21 C.F.R. §§ 1309.43 - 1309.46 and §§ 1309.51 - 1309.55. In considering the revocation or suspension of a person's waiver granted pursuant to paragraph 2 or 3 above, the DEA shall also consider whether action to revoke or suspend the person's controlled substance registration pursuant to 21 U.S.C. § 824 is warranted.

Any person exempted from the registration requirement listed above must comply with the security requirements set forth in 21 C.F.R. §§ 1309.71 - 1309.73 and the recordkeeping and reporting requirements set forth under 21 C.F.R. parts 1310, 1313, 1314, and 1315.

Exemption of Law Enforcement Personnel

Information regarding this waiver may be found at 21 C.F.R. § 1309.26.

The requirement of registration is waived for the following persons:

  1. Any officer or employee of the Administration, any officer of the U.S. Customs Service, any officer or employee of the United States Food and Drug Administration, any other Federal officer who is lawfully engaged in the enforcement of any Federal law relating to listed chemicals, controlled substances, drugs or customs, and is duly authorized to possess and distribute List I chemicals in the course of official duties; and
  2. Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to listed chemicals and controlled substances and is duly authorized to possess and distribute List I chemicals in the course of his official duties.

Any official exempted by this section may, when acting in the course of official duties, possess any List I chemical and distribute any such chemical to any other official who is also exempted by this section and acting in the course of official duties.

Registration Exemption for Regulated Sellers of Scheduled Listed Chemical Products (SLCP)

This exemption may be found at 21 U.S.C. § 823(h).

Registration is not required for regulated sellers of SLCPs. A regulated seller is a retail distributor (including a pharmacy or a mobile retail vendor).

Although exempt from registration, regulated sellers must self-certify with the DEA pursuant to Federal law (see Section IX, Retail Sales of Scheduled Listed Chemical Products). This self-certification must be renewed annually.

Registration Exemption for Mail-Order Distributors of Scheduled Listed Chemical Products (SLCP)

This exemption may be found at 21 U.S.C. § 823(h).

Mail-order distributors of SLCPs to non-regulated parties (a consumer or end-user who does not re-distribute) are exempt from registration.

Although exempt from registration, mail-order distributors must self-certify with the DEA pursuant to Federal law (see Section IX, Retail Sales of Scheduled Listed Chemical Products). This self-certification must be renewed annually.

Separate Registration for Independent Activities

Information regarding this subject may be found at 21 C.F.R. § 1309.22.

The following groups of activities are independent of each other:

  1. Manufacturing List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine;
  2. Distributing List I chemicals and SLCPs;
  3. Importing List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine; and
  4. Exporting List I chemicals and SLCPs.

Except as provided in paragraphs 1 and 2 below, 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 CSA or 21 C.F.R. §§ 1309.24 - 1309.26.

  1. A person registered to manufacture any List I chemical shall be authorized to distribute that List I chemical after manufacture, but no other chemical that the person is not registered to manufacture.
  2. A person registered to import any List I chemical shall be authorized to distribute that List I chemical after importation, but no other chemical that the person is not registered to import.

Separate Registration for Separate Locations

Information regarding this subject may be found at 21 C.F.R. § 1309.23.

A separate registration is required for each principal place of business at one general physical location where List I chemicals are manufactured, distributed, imported, or exported by a person.

The following locations are exempt from registration:

  1. A warehouse where List I chemicals are stored by or on behalf of a registered person, unless such chemicals are distributed directly from such warehouse to locations other than the registered location from which the chemicals were originally delivered; and
  2. An office used by agents of a registrant where sales of List I chemicals are solicited, made, or supervised but which neither contains such chemicals (other than chemicals for display purposes) nor serves as a distribution point for filling sales orders.

Application Process

Information regarding this subject may be found at 21 C.F.R. §§ 1309.31, 1309.32 and 1309.42.

Any person wishing to manufacture, distribute, import, or export listed chemicals shall obtain a DEA registration annually by filling out the DEA Form 510 which  may be completed online at https://www.deadiversion.usdoj.gov/webforms/jsp/regapps/common/newAppLogin.jsp.  The application fee is indicated when a business activity is selected.

 

New Applications webpage

 

A paper copy of the DEA Form 510 may be obtained by downloading the PDF version available online at http://www.deadiversion.usdoj.gov/drugreg/reg_apps/510/510_form.pdf. The completed paper application should be mailed to the address listed below for processing, along with proper payment.

Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, VA 22152-2639

DEA Form 501

On-Site Inspection

Once the DEA receives a completed DEA Form 510 application, DEA personnel from the local DEA field office will contact the applicant to schedule an on-site inspection of the premises. An on-site inspection will be conducted for every new application, regardless of whether the company currently holds a DEA registration or has been inspected previously by the DEA.

The on-site inspection serves several purposes. The DEA personnel need to examine the physical layout of the facility (both inside and out) and assess the procedures and security measures for receiving, storing, and distributing listed chemicals. The DEA personnel will also review with responsible members of the firm pertinent Federal law and regulations concerning regulated chemicals to ensure that the applicant has full understanding and knowledge of Federal requirements.

Although the exact procedure may vary, in general, the pre-registration inspection will consist of the following:

  1. Review of the completed DEA Form 510 application to verify the information is complete and accurate.
  2. Obtain a description of the company's planned activity with the List I chemical(s).
  3. Obtain information on the principals of the firm as well as those responsible for handling List I chemicals to include, but not limited to, date of birth, home address, and home phone number.
  4. Review of State and Federal licenses and certificates.
  5. Obtain supplier list and customer list.
  6. Review of the firm's business practices and procedures including procedures for identifying suspicious orders of List I and List II chemicals.
  7. Inspection of the firm's physical security and its procedures for employee screening/background checks.

Certificate of Registration

Once the DEA has approved the application, the DEA will mail a Certificate of Registration (DEA Form 223) to the registered address. The registrant shall maintain the Certificate of Registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent, or employee of the DEA or any Federal, State, or local agency engaged in enforcement of laws relating to List I chemicals or controlled substances.

If a registrant needs a duplicate DEA Certificate of Registration, he/she may:

Renewal of Chemical Registration

Information regarding this subject may be found at 21 C.F.R. § 1309.32.

A chemical registration must be renewed every year utilizing DEA Form 510a, Renewal Application for DEA Registration. To renew a registration, the most current information from the chemical handler's existing registration must be utilized. A registrant can renew online no more than 60 days prior to the current expiration date. The DEA Form 510a  may be completed online and can be found at https://www.deadiversion.usdoj.gov/webforms/jsp/regapps/common/renewalAppLogin.jsp. The cost of the application fee is provided on the online form.

 

Renewal Applications webpage

 

If the registrant has not renewed online approximately 45 days before the registration expiration date, a renewal application is sent to the registrant at the mailing address listed on the current registration. If the renewal form (DEA Form 510a) is not received by the 30th day before the expiration date of the current registration, the chemical handler should request a renewal form by using one of these options:

Note: Once the expiration date has passed and no renewal application has been received by the DEA, the chemical handler has no authority to handle List I chemicals.

Modification of Registration

Information regarding this subject may be found at 21 C.F.R. § 1309.61.

Any registrant may apply to modify his/her registration to authorize the handling of additional List I chemicals or to change his/her name or address by submitting a request online at https://www.deadiversion.usdoj.gov/webforms/jsp/regapps/common/updateLogin.jsp.

A registrant may also submit a request for modification by submitting a letter to:

Drug Enforcement Administration
Attn: Registration Section/ODR
P.O. Box 2639
Springfield, VA 22152-2639

The letter shall contain the registrant's name, address, and registration number as printed on the Certificate of Registration (DEA Form 223). The request for modification shall be handled in the same manner as an application for registration. There is no fee to modify a registration. If the modification is approved, the DEA will issue a new Certificate of Registration. The registrant should maintain the new certificate with the old certificate until expiration.

Transfer of Registration

No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the DEA Administrator may specifically designate and then only pursuant to the DEA Administrator's written consent, per 21 C.F.R. § 1309.63.

Termination of Registration

Information regarding this subject may be found at 21 C.F.R. § 1309.62.

The registration of any person shall terminate, without any further action by the DEA, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. If a registration is surrendered, termination shall occur upon receipt by any DEA employee of a duly executed DEA Form 104c or any signed writing indicating the desire to surrender a registration. Any registrant who ceases legal existence or discontinues business or professional practice or wishes to surrender a registration shall promptly notify the local Special Agent in Charge in his/her area (see Appendix P) and seek authority and instructions to dispose of any List I chemicals obtained under the authority of that registration.

Suspension or Revocation of Registration

Information regarding this subject may be found at 21 U.S.C. §§ 823(h) and 824(a).

The DEA has the authority to suspend or revoke a DEA registration upon a finding that the registrant:

  1. Has materially falsified any application filed pursuant to or required by the Controlled Substances Act (CSA) or the Controlled Substances Import and Export Act (CSIEA);
  2. Has been convicted of a felony under the CSA or CSIEA or any other law of the U.S., or of any State, relating to a controlled substance or a List I chemical;
  3. Has had a State license or registration suspended, revoked, or denied by a competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances or List I chemicals or has had the suspension, revocation, or denial of a registration recommended by competent State authority;
  4. Has committed such acts as would render his registration inconsistent with the public interest as determined under the CSA. In determining the public interest, the following factors will be considered:
    1. Maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;
    2. Compliance by the applicant with applicable Federal, State, and local law;
    3. Any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
    4. Any past experience of the applicant in the manufacture and distribution of chemicals; and
    5. Such other factors as are relevant to and consistent with the public health and safety.
  5. Has been excluded (or directed to be excluded) from participation in a program pursuant to Title 42 U.S.C. § 1320a-7(a).

 

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