Licensing Requirements

(1) Every wholesale distributor located in the Commonwealth of Massachusetts who engages in wholesale distribution of prescription drugs shall be licensed by the Board in accordance with the laws and regulations of the Commonwealth before engaging in such wholesale distribution. (2) Applications for a license to conduct a wholesale drug business in the Commonwealth shall be made upon application forms furnished by the Board. Each application shall be completely filled out and signed by each applicant under oath before a notary public. The Board shall not consider any applications within 15 days after the date of its filing with the Board. The Board shall not consider any application which has been improperly completed or which is not accompanied by the appropriate fee(s). (3) The Board may require a hearing upon the merits of any application for a license to conduct a wholesale drug business. Where such a hearing is required, the Board shall give the applicant seven days notice by certified mail, of the date, time, and place of the hearing. (4) Any person who is engaged in the wholesale drugbusiness at more thanone location shall obtain a license for each location. (5) Minimum Required Information for Licensure. The Board requiresthefollowinginforma-tion from each wholesale drug distributor as part of the initial licensing procedure and as part ofany renewal of such license: (a) The name, full business address, and telephone number of the applicant or licensee; (b) all trade or business names used by the applicant or licensee; (c) addresses, telephone numbers, and the names of contact persons for each facility used by the applicant or licensee for the storage, handling, and distribution of prescription drugs; (d) the type of ownership or operation (i.e., partnership, corporation, or sole proprietor-ship); and 1. if a person, the name of the person; 2. if a partnership, the name of each partner, and the name of the partnership; 3. if a corporation, the name and title of each corporate officer and director, the corpor-ate names, and the name of the state of incorporation, and the name of the parent company, if any; 4. if a sole proprietorship, the full name of the sole proprietor and the name of the business entity; 5. an indication as to whether the applicant or licensee will distribute controlled substances, legend drugs, and/or over-the-counter drugs, as well as a statement concerning the types of drugs to be distributed. 7.02: continued (6) Changes in any information in 247 CMR 7.02(5) shall be submitted to the Board in writing within 30 days after such change. (7) Minimum Qualifications. The Board shall consider the following factors at a minimum in issuing, renewing, or revoking a license to engage in the wholesale distribution of prescription drugs: (a) Any convictions of the applicant or licensee under any federal, state, or locallaws relat-ingto drug samples, wholesale or retail drug distribution, or distribution of controlled substances; (b) any felony convictions of the applicant or licensee under federal, state, or local laws; (c) the past experience of the applicant or licensee in the manufacture or distribution of prescription drugs, including controlled substances; (d) the furnishing by the applicant or licensee of false or fraudulent material in any application made in connection with drug manufacturing or distribution; (e) suspension, revocation, or other sanction(s) by federal, state, or local government of any license or registration currently or previously held by the applicant or licensee for the manufacture or distribution of any drugs, including controlled substances; (f) compliance with licensing or registration requirements under previously granted licenses or registrations, if any; (g) compliance with the requirements to maintain and/or make available to state licensing authorities or to federal, state, or local law enforcement officials those records required to be maintained by wholesale drug distributors; (h) failure to provide adequate control over the distribution, diversion, theft, and/or loss of drugs; (i) compliance with all requirements set forth in 247 CMR 7.00; and (j) any other factors or qualifications the Board considers relevant to and consistent with the public health and safety. (8) The Board reserves the right to denya license to an applicant if it determines that the granting of such a license would not be in the public interest. (9) Personnel. As a condition for receiving and retaining a wholesale drug distributor license, the licensee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety, and security will at all times be maintained as required by law.