CHAPTER Ph 900 MAIL-ORDER PHARMACY

Statutory Authority: RSA 318:37, II  (below - in italics)

(a) No person shall conduct or operate a mail-order pharmacy located outside of this state by shipping, mailing, or delivering prescription drugs into this state unless such pharmacy is registered in New Hampshire and a permit has been issued by the New Hampshire pharmacy board.

(b) To obtain a permit, a mail-order pharmacy shall comply with each of the following:

(1) Maintain a license in good standing from the state in which the mail-order pharmacy is located;
(2) Submit to the New Hampshire pharmacy board an application for registration as provided by the New Hampshire pharmacy board;
(3) Pay all appropriate registration fees;
(4) Submit to the New Hampshire pharmacy board a copy of the state pharmacy license from the state in which the mail-order pharmacy is located;
(5) Submit to the New Hampshire pharmacy board a copy of the state and federal controlled substance registrations from the state in which it is located, if controlled substances are to be shipped into this state.

(c) When requested to do so by the New Hampshire pharmacy board, each mail-order pharmacy shall supply the New Hampshire pharmacy board with any inspection reports, warning notices, disciplinary actions, notice of deficiency reports, or any other related reports from the state in which it is located concerning the operation of a mail-order pharmacy for review of compliance with state and federal drug laws.

(d) Except in emergencies that constitute an immediate threat to the public health and require expedited action by the board, the New Hampshire pharmacy board shall file a complaint with the licensing board of the state in which the mail-order pharmacy is located when known or suspected violations of the laws of the state in which the pharmacy is located are uncovered. If the licensing board in the state in which the mail-order pharmacy is located initiates disciplinary action, the New Hampshire pharmacy board may request the appropriate documents involved in the action for consideration of discipline against the pharmacy registration of the mail-order pharmacy. If no action is taken against the mail-order pharmacy by the licensing board of the state in which it is located, the New Hampshire pharmacy board may request copies of any investigation reports available from that state.

(e) The New Hampshire pharmacy board shall extend reciprocal cooperation to any state that licenses and regulates mail-order pharmacies for the purpose of investigating complaints against pharmacies located in New Hampshire or the sharing of information and investigative reports, as long as the other state shall extend the same reciprocal cooperation to the New Hampshire pharmacy board.  

PART Ph 901 PURPOSE AND SCOPE

Ph 901.01 Purpose and Scope. The provisions of this chapter shall apply to, and impose duties upon, all mail-order pharmacies holding registrations issued by the board.
 

PART Ph 902 DEFINITIONS

Ph 902.01 Definitions. Except where the context makes another meaning manifest, the following definitions shall apply:

(a) "Mail-order pharmacy" means any pharmacy as defined in RSA 318:1,VII-a located outside of New Hampshire that sells, ships, mails, or delivers, in any manner, prescription drugs or devices at retail into New Hampshire.

PART Ph 903 REGISTRATION

Ph 903.01 Application.

(a) No person shall conduct or operate a mail-order pharmacy located outside of this state by shipping, mailing, or delivering prescription drugs into this state unless such pharmacy is registered in New Hampshire and a permit has been issued by the New Hampshire board of pharmacy.

(b) Application form MO-1 for registration of mail-order pharmacies may be obtained from and shall be filed at the office of the board, identified in Ph 103.03.

(c) Applicants for registration shall submit an application that contains the following:

(1) Name, address, telephone number and Internet address, if applicable, of the pharmacy;

(2) The names, addresses and titles, of all principal corporate officers, if incorporated, and if unincorporated, partners, or owner of the pharmacy;

(3) The name of the pharmacist-in-charge of the location listed in (1) above;

(4) The name and address of a resident agent in New Hampshire for service of process;

(5) A copy of the current license, permit, or registration certificate issued by the regulatory or licensing agency of the state in which the pharmacy is located;

(6) Signature of the pharmacist-in-charge and date; and

(7) The prescribed fee which shall be $300.

(d) Any person or mail-order pharmacy who provides services, as defined in Ph 902.01 (a), to New Hampshire residents from more than one out-of-state pharmacy shall register each pharmacy separately.

PART Ph 904 REGISTRATIONS - CHANGES IN SUPPORTING DATA

Ph 904.01 Reporting Changes.

(a) The mail-order pharmacy to which a registration has been issued shall, within 30 days of any change, notify the board.

(b) The notice shall contain:

(1) Current New Hampshire registration number of the pharmacy;

(2) Name of the pharmacy;

(3) Address of the pharmacy, old and new, if applicable;

(4) Name of the pharmacist-in-charge, old and new, if applicable; and

(5) Name(s), addresses and titles, of new corporate officers, or partners, or owners.

(c) A new registration shall be required for a change of ownership of an established pharmacy to a successor business entity which results in a change in the controlling interest in the pharmacy.

PART Ph 905 REVOCATION AND DENIAL

Ph 905.01 Effect of Revocation and Denial.

(a) The board shall refuse to issue a registration or shall revoke a registration whenever the board finds that a mail-order pharmacy has:

(1) Made false representations or withheld material information in connection with obtaining its registration;

(2) Been found guilty of or plead guilty or nolo contendere to any felony in connection with the practice of pharmacy or the distribution of drugs;

(3) Made false representations in connection with the practice of pharmacy that endanger or are likely to endanger the health or safety of the public, or that defraud any person;

(4) Failed to comply with RSA 318:37, II and/or the provisions of Ph 900 of the New Hampshire Code of Administrative Rules; or

(5) Been the subject of a negligence complaint resulting from the dispensing of prescription drugs or devices to a resident of New Hampshire and based on an investigation of such complaint been found to be negligent:

a. By the board of pharmacy of the state in which the pharmacy is located; or

b. By the New Hampshire board of pharmacy if the board of pharmacy of the state where the pharmacy is located failed to initiate an investigation of such complaint within 45 days after referral of the complaint from the New Hampshire board of pharmacy.

(b) A mail-order pharmacy shall notify the board within 5 days of receipt of any order or decision by a board of pharmacy imposing disciplinary action on the pharmacy. Notwithstanding the provisions of paragraph (a) above, if the license, permit or registration in the state where the pharmacy is located is suspended or revoked, then the pharmacy's registration in New Hampshire, after notice and hearing, shall be immediately revoked for the same period of time.

PART Ph 906 RENEWAL OF REGISTRATIONS

Ph 906.01 Renewal Registrations Required. All mail-order registrations shall expire annually on March 31.

Ph 906.02 Renewal Application Where Obtained and Filed. Applications for the renewal of a registration for a mail-order pharmacy may be obtained from, and shall be filed at the office of the board, identified in Ph 103.03.

Ph 906.03 Renewal Application Contents and When Filed. Renewal applications shall be filed with the board in accordance with the following:

(a) Applications for renewal of a registration for a mail-order pharmacy shall be made on form MO-2.

(b) Each applicant shall provide the following on form MO-2:

(1) Name, address, telephone number and Internet address, if applicable, of the pharmacy;

(2) The name of the pharmacist-in-charge;

(3) Any ownership changes that have not been reported according to the provisions of Ph 903.01; and

(4) Signature of the pharmacist-in-charge and date.

(c) A copy of the current license, permit, or registration certificate issued by the regulatory or licensing agency of the state in which the pharmacy is located shall be submitted with the renewal application.

(d) The application and the prescribed fee of $250 shall be filed with the board no later than March 31.
 

PART Ph 907 CONDITIONS OF REGISTRATION

Ph 907.01 Compliance. As conditions of registration, the mail-order pharmacy shall comply with the following:

(a) Maintain at all times a valid unexpired permit, license, or registration to conduct the pharmacy in compliance with the laws of the state in which it is a resident;

(b) Maintain in readily retrievable form, records of legend drugs and/or devices dispensed to New Hampshire patients;

(c) Supply upon request, any and all information needed by the board to carry out its responsibilities under the statutes and rules pertaining to mail-order pharmacies;

(d) Provide for a toll-free telephone communication consultation between New Hampshire patients and a pharmacist at the mail-order pharmacy who has access to the patient's records, and ensure that said telephone number(s) will be placed upon the label affixed to each prescription container; and

(e) Provide the board, upon request, with a copy of the policies and procedures governing:

(1) Normal delivery protocols and times;

(2) Any special packaging or procedures used in delivering temperature-sensitive drug products;

(3) The procedure to be followed if the patient's medication is not available at the mail-order pharmacy, or if delivery will be delayed beyond the normal delivery time;

(4) The procedure to be followed upon receipt of a prescription for an acute illness, which shall include a procedure for delivery of the medication to the patient from the mail-order pharmacy at the earliest possible time, such as courier delivery, or an alternative that assures the patient the opportunity to obtain the medication at the earliest possible time; and

(5) The procedure to be followed when the mail-order pharmacy is advised that the patient's medication has not been received within the normal delivery time and that the patient is out of medication and requires interim dosage until mail prescription drugs become available.