New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 20 - CONTROLLED SUBSTANCES
Section 16.19.20.53 - DISPENSING WITHOUT PRESCRIPTION
Universal Citation: 16 NM Admin Code 16.19.20.53
Current through Register Vol. 35, No. 18, September 24, 2024
A. A controlled substance listed in schedule V and a substance listed in schedules II, III, or IV which is not a prescription drug as determined by FDA and the Drug and Cosmetic Act, may be dispensed by a pharmacist without a prescription provided:
(1) such dispensing is made by a pharmacist
or registered pharmacist intern and not by a non-pharmacist employee;
(2) not more than eight ounces of any
controlled substance containing opium, nor more than 48-dosage units is
dispensed at retail to the same person in any given 48-hour period;
(3) not more than four ounces of any other
controlled substance or more than 24-dosage units may be dispensed at retail to
the same person in any given 48-hour period;
(4) the purchaser is at least 18 years of
age;
(5) the pharmacist requires
every purchaser of such substance, not known to him to furnish suitable
identification (including proof of age where appropriate);
(6) a bound record book for dispensing such
substances is maintained requiring the signature and address of the purchaser,
the name and quantity of the controlled substance purchased, the date of each
purchase and the name or initials of the pharmacist who dispensed the
substance; the book shall contain a statement on each page where purchaser is
required to sign, stating no purpose of such substance has been made within the
given 48-hour period at another pharmacy and the purchaser shall be made aware
of such statement before signing the record.
B. Exempt pseudoephedrine product.
(1) Any pseudoephedrine containing product
listed as a schedule V controlled substance in Paragraph (2) of Subsection B of
16.19.20.69
NMAC shall be dispensed, sold or distributed only by a licensed pharmacist,
pharmacist intern, or a registered pharmacy technician.
(2) Unless pursuant to a valid prescription,
a person purchasing, receiving or otherwise acquiring the compound, mixture or
preparation shall:
(a) produce a driver's
license or other government-issued photo identification showing the date of
birth of the persons;
(b) sign a
log after reading the purchaser statement for pseudoephedrine receipt or other
program or mechanism indicating the date and time of the transaction, name of
the person, address, driver's license number or government issued
identification number, name of the pharmacist, pharmacist intern or pharmacy
technician conducting the transaction, the product sold and the total quantity,
in grams or milligrams, of pseudoephedrine purchased; this log will be only for
exempt pseudoephedrine products and shall be kept separate from all other
records; the log is to be produced in a way that a customer's personal
information is not available to other purchasers;
(c) be limited to no more than three and
six-tenths grams per day or more than a total of nine grams of a product,
mixture or preparation containing pseudoephedrine within a 30-day
period.
(3)
Pseudoephedrine purchaser statement must state in addition to any federal
requirements: "I have not purchased more than three and six-tenths grams today
or more than a total of nine grams of pseudoephedrine as a single entity or in
a combination with other medications in the last 30 days. Entering false
statements or misrepresentations in this logbook may subject me to criminal
penalties."
(4) Prices charged for
compounds, mixtures, and preparations that contain pseudoephedrine shall be
monitored. The board may adopt rules to prevent unwarranted price increases as
a result of compliance with this section.
(5) Pharmacies shall submit the information
collected pursuant to Paragraph (2) of Subsection B of 16.19.20.53 NMAC
electronically, in a board defined format, to the board or its agents.
Pharmacies will submit data every seven days beginning September 15, 2013.
Pharmacies may petition the executive director of the board for an alternative
method for the submission of the information collected pursuant to this
section.
(6) Authority to contract:
The board is authorized to contract with another agency of this state or with a
private vendor, as necessary, for the collection of the information collected
pursuant to Paragraph (2) of Subsection B of 16.19.20.53 NMAC. Any contract
shall be bound to comply with the provisions regarding confidentiality of
prescription or personal information in 16.19.20.53 NMAC of this regulation and
shall be subject to the penalties specified in 16.19.20 NMAC and 16.19.27
NMAC.
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