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CLINICS
Section 61-11-6(F) NMSA 1978 - requires the Board
of Pharmacy to provide for the licensing of clinics and all places
where dangerous drugs (prescription drugs) are dispensed or administered
and provide for the inspection of their facilities and activities.
16 NMAC 19.10.7.1.1 - "clinic" - means
any facility where one or more licensed practitioners diagnose and
treat patients, and where drugs are stored, dispensed, distributed
or administered for the diagnosis and treatment of the facility's
patients; provided that this definition shall not include the privately
owned practice of any licensed practitioner or group of licensed
practitioners exempt under Section 61-11-22 of the Pharmacy Act.
PROCEDURE FOR LICENSURE
1. Obtain the proper clinic application. Obtain
State and Federal Controlled Substance Registration applications
if you plan to store, administer or dispense controlled substances.
You will need a request for inspection application, the current
edition of New Mexico Board of Pharmacy Regulations, and current
schedule of Board meetings.
2. Obtain the services of a consultant
pharmacist who is responsible for the development of, implementation
and compliance with the clinic's Drug Policies and Procedures.
3. Determine the category of clinic license
to be applied for.
4. Submit the completed applications along
with the clinic's Policy and Procedure Manual. Include a drug formulary
and a rough drawing or blueprint of the floor plan.
NOTE: Dangerous drugs may not be stored at
the clinic until the Board has granted a clinic registration.
1. A separate license or permit shall be obtained
for each location.
2. Federal Controlled Substance Registration is
separate from the State's. Applications may be obtained from the
DEA by dialing 1-800-882-9539. The DEA will not issue a registration
until the state has issued a State Controlled Substance License.
3. New Mexico Board of Pharmacy Regulations can
be downloaded. Or, you may purchase them for $15.00. It will be
$18.00 if we have to mail them.
4. Drawings or blueprints should be submitted
prior to beginning construction of the drug room/drug storage area
for initial approval.
THE BOARD/STAFF PROCEDURE FOR NEW CLINIC APPLICATIONS
IS AS FOLLOWS
1. Review your floor plan/blueprints for compliance
with clinic drug storage area requirements and notify you of initial
approval.
2. Review your application(s) for completeness
and return those that are not.
3. Schedule a pre-licensing inspection of your
facility. Usually during the week prior to the next regularly scheduled
Board meeting.
4. Pre-licensing inspection: the drug inspector
will review your procedures manual, inspect your drug storage area,
review examples of your documents to be used for drug records and
discuss your consultant pharmacist's duties and responsibilities.
5. The Board will review your application(s),
procedure manual, and any other information it may require, at the
next regularly scheduled Board meeting. Clinic representatives are
encouraged to attend in order to answer questions or clarify procedures
if necessary.
6. If the application is approved by the Board,
the license is usually mailed to the new licensee within one week.
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