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NM Board of Pharmacy

Instructions for Licensure

 

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.