In-state facilities dealing with prescription drugs; out-of-state facilities in mail order pharmacy service; permits; registered agents; required pharmacist-in-charge; display of permit; penalty; refusal of permit if not in public interest.

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(A) All facilities located within this State engaging in the manufacture, production, sale, distribution, possession, or dispensing of prescription drugs or devices and all facilities located outside of this State whose primary business is mail order pharmacy service engaging in the sale, distribution, or dispensing of prescription drugs or devices in this State must be permitted by the Board of Pharmacy, and annually shall renew the permit by June first. Where operations are conducted at more than one location, each location must be permitted by the Board of Pharmacy.

This subsection does not apply to a college or university athletic department that dispenses prescription drugs or devices.

(B) Each permittee located outside of this State who ships, mails, distributes, or delivers prescription drugs or devices in this State and every pharmacy located outside of this State who ships, mails, distributes, or delivers prescription drugs or devices in this State shall designate a registered agent in this State for service of process. Any such permittee or pharmacy who does not so designate a registered agent is deemed to have designated the Secretary of State of this State to be its true and lawful attorney, upon whom may be served all legal process in any action or proceeding against such permittee growing out of or arising from such delivery. A copy of any such service of process shall be mailed to such permittee or pharmacy by the board by certified mail, return receipt requested, postage prepaid, at the address such permittee has designated on its application for licensure in this State. If any such person is not permitted in this State, service on the Secretary of State only is sufficient service.

(C) The board shall determine and promulgate the permit classifications of all permits by regulation under this chapter and establish minimum standards for such permits.

(D) Each pharmacy shall have a pharmacist-in-charge; however, a college or university athletic department pharmacy is not required to have a pharmacist-in-charge. Whenever an applicable rule requires or prohibits action by a pharmacy, responsibility is that of the permit holder and the pharmacist-in-charge of the pharmacy, whether the ownership is a sole proprietor, partnership, association, corporation, or otherwise.

(E) The board may enter into agreements with other states or with third parties for the purpose of exchanging information concerning the permitting and inspection of entities located in this jurisdiction and those located outside this State.

(F) Permits issued under this section must be displayed in a conspicuous place in the permitted facility for which it was issued in such a manner that will enable an interested person to determine the name of the permittee, permit number, and permit expiration date. The permits are not transferable.

(G) This section must not be construed as precluding any person from owning or being a permit holder if all of the dispensing, compounding, and retailing of prescription drugs in it are under the supervision and direction of a licensed pharmacist.

(H) The Board of Pharmacy may deny or refuse to renew a permit if it determines that the granting or renewing of such permit would not be in the public interest. If an application is refused, the board shall notify the applicant in writing of its decision and the reasons for its decision.

(I) A permit is required for the sale, distribution, possession, or dispensing of drugs bearing the legend "Caution: Federal law prohibits dispensing without a prescription" including, but not limited to, pharmacies (institutional or community, public or private), nursing homes, hospitals, convalescent homes, extended care facilities, family planning clinics, public or private health clinics, infirmaries, wholesalers, correctional institutions, industrial health clinics, mail order vendors, and manufacturers within or outside this State.

(J) The board shall assess a civil penalty in the amount of fifty dollars for failure to display a permit as required by this section.

(K) The Department of Health and Environmental Control is exempt from the provisions of this section that require facilities distributing or dispensing prescription drugs to be permitted by the Board of Pharmacy and from the provisions of this section that require each pharmacy to have a pharmacist-in-charge; however, each health district in this State must have a permit to distribute or dispense prescription drugs.

HISTORY: 1998 Act No. 366, Section 1; 2000 Act No. 340, Section 8; 2002 Act No. 356, Section 1, Part II.H(1),(2); 2007 Act No. 49, Section 3.A.


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