N.M. Admin. Code § 16.19.6.24 - NONRESIDENT PHARMACIES
A.
Definitions.
(1)
"Board" means the New Mexico board of pharmacy.
(2)
"Nonresident pharmacy" means
any pharmacy located outside New Mexico that ships, mails or delivers in any
manner prescription drugs to New Mexico patients or consumers. For purposes of
this definition only, "delivers" includes the provision of dispensing process
pharmacy services such as prescription entry, prospective drug review, or
prescription verification.
(3)
"Prescription drugs" means any drug required by federal or New
Mexico law or regulation to be dispensed only by a prescription and includes
"dangerous drugs" and "controlled substances" as defined by federal and New
Mexico law.
(4)
"Resident
state" means the state in which the nonresident pharmacy is a
resident.
B.
Licensure requirement.
(1) No
nonresident pharmacy shall ship, mail or deliver prescription drugs to a
patient in this state unless licensed by the board. In addition, no nonresident
pharmacy shall ship, mail or deliver controlled substances to a patient in this
state unless registered by the drug enforcement administration and the board
for controlled substances.
(2)
Separate Licensure. Any person that ships, mails or delivers prescription drug
to New Mexico patients from more than one nonresident pharmacy shall obtain a
separate New Mexico nonresident pharmacy license for each
pharmacy.
C. Requirements
for obtaining licensure.
(1) Application.
Each nonresident pharmacy applying for licensure shall submit an application to
the board which includes the following minimum information:
(a) The address of the principle office of
the nonresident pharmacy and the name and titles of all principal corporate
officers and all pharmacists who are dispensing prescription drugs to persons
in New Mexico. A report containing this information shall be made on an annual
basis and within 30 days after any change of office location, corporate officer
or pharmacist in charge;
(b) Proof
that the nonresident pharmacy maintains a valid license, permit or registration
to operate the pharmacy in compliance with the laws of the resident
state;
(c) A copy of the most
recent inspection report resulting from an inspection of the nonresident
pharmacy conducted by the regulatory or licensing agency of the resident
state;
(d) If compounded sterile
preparations (CSP) are to be shipped into New Mexico, a copy of the most recent
CSP operations inspection report conducted by the regulatory or licensing
agency of the resident state (or party recognized by that agency to perform
such inspection, or party recognized by the board) which demonstrates the
pharmacy operates in conformance with the requirements of applicable USP/NF
General Chapters numbered below 1000. The inspection must have occurred within
the 12 months immediately preceding receipt of the license application by the
board. The board may deny licensure unless the applicant submits documentation
satisfactory to the board that any deficiencies noted in the inspection report
have been corrected. For entities also acting as outsourcing facilities, the
required standard of operation shall be current good manufacturing practices
(cGMP).
(e) The policy and
procedure manual required by Paragraph (2) of Subsection D of
16.19.6.24 NMAC;
(f) Proof that the nonresident pharmacy has a
toll-free telephone service available to New Mexico patients;
(g) The name and address of a resident in New
Mexico for service of process;
(h)
If the nonresident pharmacy wants to ship, mail or deliver controlled
substances to New Mexico patients, then the pharmacy must submit an application
for controlled substances under 16.19.20 NMAC; and
(j) An application that is
not successfully completed within 12 months of the date of initial receipt by
the board will be considered withdrawn. For consideration of license issuance,
a new application and fee are required.
(2) Agent of record. Each nonresident
pharmacy that ships, mails or delivers prescription drugs to a patient in New
Mexico shall designate a resident agent in New Mexico for service of process.
If a nonresident pharmacy does not designate a registered agent, the shipping,
mailing, or delivering of prescription drugs in the state of New Mexico shall
be deemed an appointment by such nonresident pharmacy of the secretary of state
to be its true and lawful attorney upon whom may be served all legal process in
any action or proceeding against such pharmacy growing out of or arising from
such delivery.
(3) A nonresident
pharmacy may apply for license renewal by submitting a renewal application on a
form provided by the board.
D. Conditions of licensure.
(1) Compliance. Each nonresident pharmacy
licensed by the board must comply with the following:
(a) all statutory and regulatory requirements
of the state of New Mexico regarding controlled substances, drug product
selection, and the labeling, advertising, and dispensing of prescription drugs
including all requirements that differ from federal law or regulations, unless
compliance would violate the laws and regulations of the resident
state;
(b) maintain, at all times,
a valid license, permit, or registration to operate the pharmacy in compliance
with the laws of the resident state;
(c) maintain, if applicable, a federal
registration for controlled substances;
(d) supply, upon request from the board or
the regulatory or licensing authority of the resident state, all information
needed to carry out the board's responsibilities under state and federal
law;
(e) provide a toll-free
telephone service to facilitate communication between patients in this state
and a pharmacist at the nonresident pharmacy who has access to the patient's
records. A nonresident pharmacy shall provide the toll-free telephone service
during its regular hours of operation, but not less than six days a week and
for a minimum of 40 hours a week. The toll-free telephone number shall be
disclosed on a label affixed to each container of drugs dispensed to patients
in this state.
(2) Policy
and procedure manual. Each nonresident pharmacy shall develop and provide the
board with a policy and procedure manual that sets forth:
(a) normal delivery protocols and
times;
(b) the procedure to be
followed if the patient's medication is not available at the nonresident
pharmacy, or if delivery will be delayed beyond the normal delivery
time;
(c) 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 (i.e., courier
delivery), or an alternative that assures the patient the opportunity to obtain
the medication at the earliest possible time;
(d) the procedure to be followed when the
nonresident 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 mailed prescription drugs become
available;
(e) the procedure for
ensuring proper medication storage conditions until the medication is delivered
to the patient.
E.
Disciplinary proceedings.
(1) The board may withhold, suspend, or
revoke any nonresident pharmacy license held or applied for upon the grounds
established by law or regulations, including, without limitation, the failure
to comply with the conditions specified in Subsection C of
16.19.6.24 NMAC. The board shall
suspend or revoke a nonresident pharmacy license when the license, permit, or
registration to operate the pharmacy in the resident state has been suspended
or revoked. A certified copy of the record of suspension or revocation by the
resident state is conclusive evidence.
(2) Upon receipt of information indicating
that the nonresident pharmacy may have violated the laws or regulations of the
resident state, the board may file a complaint against the nonresident pharmacy
with the regulatory or licensing authority of the resident
state.
F.
Limitations.
(1) Nothing in this
regulation shall be construed to authorize the dispensing of contact lenses by
nonresident pharmacies.
(2) Nothing
in this regulation is intended to replace or modify any requirements that a
nonresident business may be subject to under any other law or
regulation.
Notes
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