Md. Code Regs. 10.34.22.03

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.34.22.03 - Minimum Application Requirements for Applicants Holding Product

A. The Board shall require the following minimum information from a wholesale distributor as part of an application for a permit and as part of a renewal of a permit:

(1) The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship;

(2) The full name or names of the owner and the operator of the wholesale distributor applying for or renewing a permit, including:

(a) For an individual, the:

(i) Full name of the individual;

(ii) Telephone number of the individual;

(iii) Business address of the individual; and

(iv) Date of birth of the individual;

(b) For a partnership, the:

(i) Full name of each partner;

(ii) Telephone number of the partnership;

(iii) Address of each partner;

(iv) Date of birth of each partner;

(v) Business address of the partnership; and

(vi) Federal employer identification number of the partnership;

(c) For a publicly traded corporation, the:

(i) Full name and title of each corporate officer and director;

(ii) Telephone number of the publicly traded corporation;

(iii) Business address of the corporation;

(iv) Federal employer identification number of the corporation;

(v) Name of parent company or companies if applicable;

(vi) Corporate names;

(vii) Name of the state of incorporation; and

(viii) Name and address of the resident agent of the corporation;

(d) For a nonpublicly traded corporation, the:

(i) Full name and title of each corporate officer and director;

(ii) The telephone number of the nonpublicly traded corporation;

(iii) Business address of the corporation;

(iv) Federal employer identification number of the corporation;

(v) Name of parent company or companies if applicable;

(vi) Corporate names;

(vii) Full name and business address of shareholders of more than 10 percent of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange;

(viii) Name of the state of incorporation; and

(ix) Name and address of the resident agent of the corporation;

(e) For a sole proprietorship, the:

(i) Full name of the sole proprietor;

(ii) The telephone number of the sole proprietor;

(iii) Full name of the business entity;

(iv) Business address; and

(v) Date of birth of the sole proprietor;

(f) For a limited liability company, the:

(i) Full name and business address of the limited liability company;

(ii) Telephone number of the limited liability company;

(iii) Full name of each member;

(iv) Full name of each manager;

(v) Federal employer identification number of the limited liability company;

(vi) Name of the state in which the limited liability company was organized; and

(vii) Name and address of the resident agent of the company;

(3) Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs;

(4) All trade or business names used by the permit holder which may not be identical to the name used by another unrelated applicant in the State;

(5) A list of federal and state licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by federal authority or another state that authorizes the wholesale distributor to purchase, possess, and distribute prescription drugs or devices;

(6) A list of disciplinary actions by federal or state agencies against the wholesale distributor as well as any such actions against principals, owners, directors, or officers;

(7) For the designated representative and the immediate supervisor of the designated representative at the applicant's place of business the following information:

(a) Names;

(b) Places of residence for the past 7 years;

(c) Dates and places of birth;

(d) The name and address of each business where the individual was employed during the past 7 years, and the individual's job title or office held at each business;

(e) A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding;

(f) A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event;

(g) A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years, with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party;

(h) A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of the guilt was withheld or whether the individual pled guilty or nolo contendere;

(i) If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and

(j) A photograph of the individual taken in the previous 180 days;

(8) A full description of the facility and warehouse including:

(a) Square footage;

(b) Security and alarm system descriptions;

(c) Terms of lease or ownership;

(d) Address; and

(e) Description of temperature and humidity controls;

(9) Written evidence that the wholesale distributor has obtained general and product liability insurance;

(10) A description of the wholesale distributor's import and export activities; and

(11) Other relevant information that the Board may require.

B. Criminal Background Check Requirements for an Applicant Located in this State. The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to the Central Repository and the Federal Bureau of Investigation:

(1) Electronically or digitally captured fingerprints at approved electronic fingerprint locations approved by the Director of the Central Repository ;

(2) The fee authorized under the Criminal Procedure Article, § 10-221(b)(7), Annotated Code of Maryland, for access to State criminal history records; and

(3) The processing fee required by the Federal Bureau of Investigation for a national criminal history records check.

B-1.Criminal Background Check Requirements for an Applicant Located Outside this State.

(1)The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to a criminal history records check by the applicant's state of residence, in accordance with the laws of the applicant's state of residence.

(2) The criminal history records check shall consist of:

(a) A state criminal history records check for the applicant's state of residence; and

(b) A national criminal history records check.

(3) The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant's state of residence to forward the results of the criminal history records check to the Board and the applicant.

(4) If the appropriate entity in the applicant's state of residence is unable to forward the results of the criminal history records check, then the designated representative and the immediate supervisor of the designated representative of an applicant shall ensure that the results of the criminal history records check are forwarded to the Board in a manner approved by the Board.

C. The information required under §A of this regulation shall be provided under oath.

D. The Board may not issue an initial or renewal wholesale distributor permit to an applicant unless the Board or its designee:

(1) If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant's place of business, including any facility of the applicant;

(2) Finds that the place of business and facility, if any, meets the Board's requirements;

(3) Determines that the designated representative of the applicant meets the following qualifications:

(a) Is 21 years old or older;

(b) Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;

(c) Is employed by the applicant full time in a managerial level position;

(d) Is actively involved in, and aware of, the daily operation of the wholesale distributor;

(e) Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours;

(f) Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in § 1504 of the Internal Revenue Code;

(g) Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and

(h) Does not have any convictions for a felony under federal, State, or local laws; and

(4) Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications:

(a) Is 21 years old or older;

(b) Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;

(c) Is employed by the applicant full time in a managerial level position;

(d) Is actively involved in, and aware of, the daily operation of the wholesale distributor;

(e) Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution, or distribution of controlled substances; and

(f) Does not have any convictions for a felony under federal, state, or local laws.

E Surety Bond.

(1)

(2) The surety bond, or other security, shall be in the amount of:

(a) $100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or

(b) $50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000.

(3) An applicant shall submit the following documentation to verify the applicant's annual gross receipts in the State are less than $10,000,000 for the previous tax year:

(a) A federal tax return; or

(b) An annual sales report specifying the sales of prescription drugs and devices in the State audited by a certified public accountant.

(4) A surety bond is not required for a pharmacy warehouse that is not engaged in wholesale distribution.

(5) An applicant shall obtain a surety bond for each facility.

(6) A single surety bond may cover all facilities operated by the applicant within this State.

F. If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility.

G. The Board shall notify the applicant of the Board's acceptance or rejection of the application within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks.

H. The applicant shall pay to the Board an application fee set forth in COMAR 10.34.09.02.

I. The wholesale distributor shall provide changes in information provided pursuant to Regulation .03 of this chapter to the Board within 30 days of the effective date of the change.

J. Information and qualification requirements for obtaining a permit under this regulation, beyond that required by federal law, does not apply to a manufacturer who distributes its own prescription:

(1) Drugs approved by the U.S. Food and Drug Administration; or

(2) Devices that are approved or authorized by the U.S. Food and Drug Administration.

Md. Code Regs. 10.34.22.03

Regulations .03 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulation .03E amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529)
Regulations .03 adopted effective April 7, 2008 (35:7 Md. R. 748)
Regulations .03, adopted effective 41:10 Md. R. 561, eff.7/1/2014