ASSEMBLY, No. 1624
STATE OF NEW JERSEY
INTRODUCED MARCH 4, 1996
By Assemblymen IMPREVEDUTO and COHEN
An Act concerning the registration of certain out-of-State mail-order pharmacies and nonresident pharmacists and supplementing chapter 14 of Title 45 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. As used in this act:
"Nonresident affiliate pharmacist" means a person registered as a pharmacist in the District of Columbia or any state or territory of the United States who is employed by a nonresident pharmacy and whose duties include filling prescriptions received by the nonresident pharmacy from residents of New Jersey.
"Nonresident pharmacy" means a pharmacy located in the United States whose primary business is mail-order prescription service and which solicits prescription business in New Jersey or ships, mails or delivers prescription drugs or devices to residents of New Jersey.
2. A nonresident affiliate pharmacist shall not fill a prescription for a New Jersey resident whose mailing address is located in New Jersey unless registered pursuant to the provisions of this act.
3. a. The Board of Pharmacy of the State of New Jersey shall issue a certificate as a registered nonresident affiliate pharmacist to a nonresident affiliate pharmacist who submits a written application to the board on forms provided by it; pays a fee as prescribed by the board; and successfully completes a board approved examination testing an applicant's knowledge of the laws and regulations of New Jersey governing the practice of pharmacy. A certificate as a registered nonresident affiliate pharmacist shall authorize the holder to practice pharmacy in this State.
b. The board may authorize an applicant to take the examination required for registration pursuant to subsection a. of this section in the district, state or territory in which the applicant is employed as a nonresident affiliate pharmacist under the auspices of the licensing authority in that jurisdiction. The licensing authority shall return the completed unmarked examination to the Board of Pharmacy of the State of New Jersey for grading of the examination.
4. A registered nonresident affiliate pharmacist shall, biennially, on a date that the board prescribes, pay a registration renewal fee. The board shall fix the biennial registration renewal fee for a registered nonresident affiliate pharmacist at one-half the biennial registration renewal fee charged to a pharmacist registered to practice pharmacy in the State of New Jersey.
5. A renewal certificate of registration shall not be issued by the board to a registered nonresident affiliate pharmacist until the applicant submits satisfactory proof to the board that he has completed the continuing pharmaceutical education requirements specified in P.L.1972, c.61 (C.45:14-11.2 et seq.).
6. A nonresident pharmacy shall not solicit prescription business or ship, mail or deliver prescription drugs or devices to a New Jersey resident whose mailing address is located in New Jersey unless the pharmacy is registered with the board and the board has issued a permit to the nonresident pharmacy.
The fee for a permit that is established, prescribed or charged pursuant to this section shall be established, prescribed or charged to the extent as shall be necessary to defray all proper expenses incurred by the board in administering the provisions of this section.
7. Upon application made on a form prescribed and furnished by the board, and upon payment of the required fee, the board shall issue a permit to a nonresident pharmacy which is deemed qualified. A permit may be issued and shall remain in effect only during the period in which the nonresident pharmacy satisfies the following requirements:
a. Is licensed and in good standing in the state, territory or district in which it is located;
b. Designates a resident agent in New Jersey;
c. Maintains, in readily retrievable form, records of legend drugs or devices dispensed to patients whose mailing address is in New Jersey;
d. Supplies, upon request, all information needed by the Board of Pharmacy of the State of New Jersey to carry out the board's responsibilities under the statutes and regulations pertaining to nonresident pharmacies;
e. Maintains pharmacy hours that permit the timely dispensing of drugs to patients in New Jersey and provides reasonable access for these patients to consult with a pharmacist concerning patients' medications;
f. Provides toll-free telephone consultations between patients in New Jersey and a pharmacist at the nonresident pharmacy who has access to the patients' records, and ensures that the telephone number of the nonresident pharmacy is placed upon the label affixed to each legend drug container;
g. Complies with the statutory and regulatory requirements of the State of New Jersey for controlled substances;
h. Complies with the statutory and regulatory requirements of the State of New Jersey regarding generic substitution;
i. Complies with the statutory and regulatory labeling requirements of the State of New Jersey;
j. Complies with the statutory and regulatory requirements of the State of New Jersey for dispensing prescriptions in accordance with the quantities indicated by the prescriber;
k. Develops and provides the Board of Pharmacy of the State of New Jersey with a policy and procedure manual that sets forth;
(1) Normal delivery protocols and times;
(2) A policy on the procedure to be followed if a patient's medication is not available at the nonresident pharmacy, or if delivery will be delayed beyond the normal delivery time;
(3) A policy on the procedure to be followed upon receipt of a prescription for an acute illness, which policy shall include a procedure for delivery of the medication to the patient from the nonresident pharmacy at the earliest possible time or an alternative that assures the patient the opportunity to obtain the medication at the earliest possible time; and
(4) A policy on the procedure to be followed when advised that the patient's medication has not been received within the normal delivery time and the patient is out of medication and requires interim dosage until mailed legend drugs become available;
l. Retains a current copy of: chapter 14 of Title 45 of the Revised Statutes; regulations of the Board of Pharmacy of the State of New Jersey contained in Title 13 of the New Jersey Administrative Code; the list of interchangeable drug products prepared by the New Jersey Drug Utilization Review Council; and the regulations adopted pursuant to the "New Jersey Controlled Dangerous Substances Act," P.L.1970, c.226 (C.24:21-1 et seq.); and
m. Ensures that prescriptions received from New Jersey patients whose mailing address is in New Jersey shall be filled by a nonresident affiliate pharmacist who is registered by the Board of Pharmacy of the State of New Jersey.
8. Except in emergencies that constitute an immediate threat to public health and require prompt action by the Board of Pharmacy of the State of New Jersey, the board shall file a complaint against any nonresident pharmacy or nonresident affiliate pharmacist that violates any provision of this act with the licensing authority in the district, state or territory in which the pharmacy is located or the pharmacist is employed. If the licensing authority in that district, state or territory fails to resolve the violation within 90 days from the date the complaint is filed, disciplinary proceedings shall be instituted in New Jersey before the Board of Pharmacy of the State of New Jersey. Any notice of complaint to the licensing authority shall also be sent to the nonresident pharmacy and the nonresident affiliate pharmacist and a copy shall be sent to the resident agent.
9. Nothing in this bill shall be construed to impact on the receipt of pharmaceutical services by a New Jersey resident who seeks to have a prescription filled at an out-of-State community pharmacy while traveling outside of New Jersey.
10. This act shall take effect on the 90th day following enactment.
STATEMENT
Pharmacies that ship, mail, or deliver prescription legend drugs or devices to a patient in another state are engaged in the practice of pharmacy in the state where the patient resides, and this practice impacts on the safety and welfare of the public. Accordingly, there is a need to regulate this practice to protect public health.
This bill requires out-of-State mail-order pharmacies to obtain a permit and become registered by the Board of Pharmacy of the State of New Jersey in order to solicit prescription business in this State or to ship, mail, or deliver prescription drugs or devices to patients whose mailing address is located in New Jersey. The bill also requires a nonresident pharmacist working for these out-of-State mail-order pharmacies, whose duties include filling prescriptions for patients residing in New Jersey, to pass a board approved examination and to be registered as nonresident affiliate pharmacists.
The bill stipulates that nothing in its provisions shall be construed to impact on the receipt of pharmaceutical services by a New Jersey resident who seeks to have a prescription filled at an out-of-State community pharmacy while traveling for work or pleasure.
Regulates out-of-State mail-order pharmacies and their employed pharmacists providing services to New Jersey residents.