10.19.03.03

.03 Registration; Registration Certificate.

A. Requirement. A person shall register with the Department and obtain and maintain a registration certificate before the person:

(1) Manufactures, distributes, or dispenses controlled dangerous substances;

(2) Conducts research or instructional activities with controlled dangerous substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland;

(3) Conducts research or instructional activities with a controlled dangerous substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland; or

(4) Conducts a chemical analysis with controlled dangerous substances listed in any schedule.

B. Application.

(1) A person required to obtain and maintain a registration certificate as set forth under this chapter shall:

(a) Obtain, complete, and submit an application for a registration certificate on a form provided by the Department; and

(b) Pay the appropriate fee as set in §C of this regulation, unless the applicant is eligible for a fee exemption.

(2) The application and any accompanying document or statement required for registration by the Secretary shall be signed by the:

(a) Applicant, if an individual;

(b) General partner, if the applicant is a partnership; or

(c) Officer responsible for the applicant, if the applicant is a corporation or other entity.

(3) If the information requested on the application is not applicable to the applicant, the applicant shall indicate this on the form.

(4) The Secretary may require additional documentation pertinent to the registration to:

(a) Clarify application information; or

(b) Determine if the applicant meets the requirements of this chapter.

(5) A person shall submit an application and fee for each separate place of business, professional practice, or location for which registration is required.

(6) The registration certificate shall be readily available to any agent or representative of the Secretary within the registered location.

C. Fees.

(1) A person required to obtain and maintain a registration certificate as set forth under this chapter shall pay the appropriate fees as set in this regulation. Fees include the following:

(a) Registration every 3 years — $120;

(b) Amend an unexpired registration certificate — $50; and

(c) Replace a lost registration certificate — $30.

(2) Persons Exempt from Fee.

(a) The following persons are exempt from payment of a fee for registration or renewal of registration:

(i) A hospital, clinic, institution, facility, or unit operated by the State or by the United States;

(ii) An agency, excluding State employees, for which the State is responsible for payment of the fee, provided that the exemption is approved by the Secretary; and

(iii) A person included in 21 CFR §§1301.21—1301.24.

(b) A person exempt from payment of a registration fee is required to obtain and maintain a registration certificate.

(3) Payment of Prorated Fees.

(a) A registrant applying for a registration certificate shall pay a prorated registration fee when a registration certificate is issued for less than 36 months.

(b) The prorated fee shall be based on the total number of full plus partial months for which the registration certificate is issued.

(4) Refunds and Credits. The Secretary may not issue a refund or credit or return any registration fees to a registrant, including if a registrant:

(a) Withdraws a registration application; or

(b) Voluntarily or involuntarily ceases to manufacture, distribute, or dispense a controlled dangerous substance before a registration certificate expires.

(5) Failure to Pay Fees. The Secretary may not issue a new or a renewed registration certificate until all required fees are paid.

D. Issuance. The Secretary may issue a registration certificate that:

(1) Is valid for not more than 3 years; and

(2) Shall be renewed before its expiration date if the registrant intends to operate as described in §A of this regulation.

E. Expiration and Renewal.

(1) A registration certificate expires on the date shown on the certificate.

(2) The Secretary shall mail a renewal application or a notice to renew to a registrant not less than 30 days before the expiration date shown on the certificate.

F. Assignment, Transfer, or Termination.

(1) A registration certificate is not transferable.

(2) A registration certificate becomes void when the registrant:

(a) Dies;

(b) Discontinues business or professional practice in the State; or

(c) Changes ownership, including when:

(i) Partners are added or deleted from the partnership;

(ii) There is a change in the president or chief executive officer of the corporation; or

(iii) There is a change in the ownership of 10 percent or more of the outstanding shares in the corporation.

(3) A registrant who discontinues business or professional practice in the State shall:

(a) Notify the Secretary in writing;

(b) Surrender the registrant's current registration certificate; and

(c) Legally transfer or dispose of any controlled dangerous substances relative to the registrant's operation.

(4) Change of Ownership.

(a) A registrant who changes ownership of the business or professional practice as stated in §C(2)(c) of this regulation, shall:

(i) Notify the Secretary in writing;

(ii) Submit a registration application to change the current registration and a $144 3-year registration fee at least 30 days before the change in the ownership of the registrantís business or professional practice occurs; and

(iii) Surrender the registrant's current registration certificate after the ownership change is finalized.

(b) After a change in ownership, the Secretary may inspect the business or professional practice of the new owners as provided in §G of this regulation.

(5) Change of Location. A registrant shall submit an application to amend a current registration certificate along with a $50 fee at least 30 days before there is a change in the location of the registrant's place of business or professional practice from the location which is stated on the registration certificate to a new location within the State.

G. Inspection. After an application for registration has been filed, the Secretary may:

(1) Inspect the place of business or professional practice described in the application; and

(2) Investigate the applicant to determine whether the applicant meets the requirements of this chapter.