(1) Any prescription drug outlet located outside this state that ships, mails, or delivers, in any manner, drugs or devices into this state is a nonresident prescription drug outlet and shall register with the board and disclose to the board the following:
(a) The location, names, and titles of all principal entity officers and all pharmacists who are dispensing drugs or devices to the residents of this state. The nonresident prescription drug outlet shall submit a report containing this information to the board on an annual basis and within thirty days after any change of office, officer, or pharmacist.
(b) A verification that it complies with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. The nonresident prescription drug outlet shall maintain at all times a valid, unexpired license, permit, or registration to conduct the prescription drug outlet in compliance with the laws of the state in which it is a resident. As a prerequisite to registering with the board, the nonresident prescription drug outlet shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located.
(2) The registration requirements of this section apply only to a nonresident prescription drug outlet that only ships, mails, or delivers, in any manner, drugs and devices into this state pursuant to a prescription order.
(3) A nonresident prescription drug outlet doing business in this state that has not obtained a registration shall not conduct the business of selling or distributing drugs in this state without first registering as a nonresident prescription drug outlet. A nonresident prescription drug outlet shall make application for a nonresident prescription drug outlet registration on a form furnished by the board. The board may require the information it deems necessary to carry out the purpose of this section.
(4) (a) The board may deny, revoke, or suspend a nonresident prescription drug outlet registration for failure to comply with this section or with any rule promulgated by the board.
(b) The board may deny, revoke, or suspend a nonresident prescription drug outlet registration if the nonresident prescription drug outlet's license or registration has been revoked or not renewed for noncompliance with the laws of the state in which it is a resident.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1480, � 1, effective October 1.
Editor's note: This section is similar to former � 12-42.5-130 as it existed prior to 2019.
12-280-133.5. Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules. (1) A nonresident 503B outsourcing facility shall not conduct the business of distributing compounded prescription drugs in this state without first registering with the board as a nonresident 503B outsourcing facility. A nonresident 503B outsourcing facility shall apply for a nonresident 503B outsourcing facility registration on a form furnished by the board and shall submit the following to the board with the application:
(a) Proof that the facility is actively registered with the FDA as a 503B outsourcing facility and is actively licensed, permitted, or registered in the state in which it is a resident;
(b) The location, names, and titles of all principal entity officers and the name of the pharmacist in charge of the operations of the facility;
(c) Verification that the facility complies with all lawful directions and requests for information from the FDA and from the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, as well as with all requests for information made by the board pursuant to this section;
(d) A copy of the most recent inspection report resulting from an inspection conducted by the FDA; and
(e) Any other information the board deems necessary to carry out the purpose of this section.
(2) A nonresident 503B outsourcing facility shall:
(a) Maintain at all times a valid, unexpired license, permit, or registration to operate the 503B outsourcing facility in compliance with the laws of the state in which it is a resident; and
(b) Comply with the requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 301 et seq., as amended, or the DQSA or with FDA regulations implementing either act.
(3) The board may deny, revoke, or suspend a nonresident 503B outsourcing facility registration if:
(a) The facility fails to comply with this section or with any rule promulgated by the board;
(b) The FDA has revoked or refused to renew the nonresident 503B outsourcing facility's FDA registration for failing to comply with the requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 301 et seq., as amended, the DQSA, or FDA regulations implementing either act or the facility's FDA registration has expired or is no longer active; or
(c) The state in which the nonresident 503B outsourcing facility resides has revoked or refused to renew the facility's license, permit, or registration for failing to comply with the laws of that state or the facility's license, permit, or registration in another state has expired or is no longer active.
(4) The board may adopt rules as necessary to implement this section.
Source: L. 2021: Entire section added, (SB 21-094), ch. 314, p. 1935, � 18, effective September 1.
12-280-133.7. Third-party logistics providers - registration - denial, revocation, or suspension - rules. (1) A third-party logistics provider shall not conduct business in this state without first registering with the board as a third-party logistics provider. A third-party logistics provider shall apply for a registration on a form furnished by the board and shall submit the information required pursuant to rules adopted by the board. The board shall specify, by rule, the information a third-party logistics provider must submit with its application for a registration.
(2) A third-party logistics provider shall comply with all lawful directions and requests for information from the FDA, the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, and the board.
(3) The board may deny, revoke, or suspend a third-party logistics provider registration if:
(a) The third-party logistics provider fails to comply with this section or with any rule promulgated by the board;
(b) The FDA has revoked or refused to renew the third-party logistics provider's FDA registration for failing to comply with the requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 301 et seq., as amended, or the DQSA or with FDA regulations implementing either act; or
(c) The state in which the third-party logistics provider resides has revoked or refused to renew the provider's license, permit, or registration for failing to comply with the laws of that state.
(4) The board may adopt rules as necessary to implement this section.
Source: L. 2021: Entire section added, (SB 21-094), ch. 314, p. 1937, � 18, effective September 1.