TITLE 16 OCCUPATIONAL AND PROFESSIONAL
LICENSING
CHAPTER 19 PHARMACISTS
PART 14 DEVICES;
MEDICAL GAS REPACKAGERS AND SELLERS
16.19.14.1 ISSUING AGENCY: Board of Pharmacy.
[16.19.14.1 NMAC –
Rp, 16.19.14.1 NMAC, 2/28/2023]
16.19.14.2 SCOPE: All individuals and entities subject to the
New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article I NMSA 1978.
[16.19.14.2 NMAC –
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16.19.14.3 STATUTORY AUTHORITY: Paragraph 7 of Subsection A of Section 61-11-6
NMSA 1978 authorizes the Board to enforce the provisions of all state laws
pertaining to the practice of pharmacy and the manufacture, production, sale or
distribution of drugs, cosmetics or poisons, including the New Mexico Drug,
Device and Cosmetic Act. Paragraphs 18
and 19 of Subsection B of Section 61-11-14 NMSA 1978 authorize the Board to
license and otherwise establish minimum standards for medical gas sellers and
repackagers. Section 26-1-18 NMSA 1978
of the Drug, Device and Cosmetic Act authorizes the Board to promulgate
regulations for the efficient enforcement of the Act.
[16.19.14.3 NMAC –
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16.19.14.4 DURATION: Permanent.
[16.19.14.4 NMAC –
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16.19.14.5 EFFECTIVE DATE: February 28, 2023, unless a different date is
cited at the end of a Section or Paragraph.
[16.19.14.5 NMAC –
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16.19.14.6 OBJECTIVE: The objective of Part 14 of Chapter 19 is to
establish mandatory controls and performance standards for health care devices
so as to minimize the risk of injury from the distribution and use of
adulterated or misbranded devices.,and to establish standards for the
repackaging and selling of medical gases, so as to minimize the risk of injury
from the distribution and use of adulterated or misbranded medical gases.
[16.19.14.6 NMAC –
Rp, 16.19.14.6 NMAC, 2/28/2023]
16.19.14.7 DEFINITIONS:
A. "Device", as used in the New Mexico Drug
and Cosmetic Act, is any health care product that does not achieve any of its
principal intended purpose through chemical action within or on the body of man
or other animal and which is not dependent upon being metabolized for
achievement of any of its principal intended purposes.
B. “Board” means the New Mexico board of
pharmacy.
C. “Distribution of medical gases” means the
distribution of medical gas, to persons other than consumers or patients.
D. "Drug order" means a prescription drug
order issued by a licensed prescriber for medical gas.
E. “FDA” means the United States Food and Drug
Administration.
F. “Federal Act” means the Federal Food, Drug and
Cosmetic Act.
G. “Medical gas” means:
(1) a drug that is manufactured or stored
in a liquefied, nonliquefied, or cryogenic state and is administered as a gas;
and
(2) that is labeled for medical use in
compliance with federal law and is otherwise a designated medical gas as
defined at 21 U.S.C. Section 360ddd(1) of the Federal Act, including each of
the following that meets the standards set forth in an official compendium:
oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, and medical air.
H. “Medical gas repackager” means a person that manufactures
or repackages a medical gas, which includes producing, cascading, distributing,
filling, mixing, purifying, separating, transferring, and transfilling medical
gases. This includes original manufacturers as defined by the FDA that
repackage medical gas and have a valid registration as a drug establishment
with the FDA. A medical gas manufacturer shall be issued the license type
medical gas repackager.
I. “Medical gas seller” means a person licensed to
distribute a medical gas to a person other than a consumer or patient, or to
supply medical gases on drug orders to a patient or ultimate user.
J. “Repackage” means persons or entities
manufacturing bulk medical gases or transferring gas or liquefied gas product
from one container to another (e.g., liquid to gas, gas to gas, liquid to liquid).
[16.19.14.7 NMAC –
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16.19.14.8 CLASSIFICATION OF DEVICES: Three regulatory classes are
established based on the extent of control necessary to ensure safety and
effectiveness of each device:
A. Class I -- General Controls
(1) prohibiting adulteration or
misbranding
(2) requiring federal registration and
listing by the manufacturer
(3) requiring notification of risks,
repairs, replacement or refund
(4) requirement restricting sale,
distribution or use
(5) requirement with respect to good
manufacturing practices, record keeping, reports and inspections
(6) authority to ban the device
B. Class II -- Performance Standards
(1) general controls not sufficient to
assure safety and effectiveness
(2) performance standards required by
federal FDA
(3) FDA regulations establishing the
performance standard.
C. Class III -- Pre-Market Approval
(1) represents life sustaining,
life-supporting or implanted in the body or which presents a potential
unreasonable risk of illness or injury.
(2) requires investigational device
exemption for research (IDE under federal act Sec. 520 (g)).
[16.19.14.8 NMAC –
Rp, 16.19.14.8 NMAC, 2/28/2023]
16.19.14.9 ADULTERATION: A device may be considered to be
adulterated:
A. It is subject to a performance standard and does not
comply with all requirements of such standard.
B. Class II device FDA pre-market approval is not completed.
C. It is a banned device.
D. It is in violation of good manufacturing practice
requirements.
E. It fails to comply with the IDE (Investigational Device
Exemption) protocol.
[16.19.14.9 NMAC –
Rp, 16.19.14.9 NMAC, 2/28/2023]
16.19.14.10 MISBRANDING: A device may be deemed to be
misbranded if:
A. Manufactured in a nonregistered establishment pursuant to
federal requirements.
B. If advertising and description literature fails to meet
minimum requirements for disclosure of product information.
C. Devices subject to performance standards set by FDA,
whose labeling fails to meet those prescribed in the standard.
D. Devices that fail or whose manufacturer refuses to comply
with requirements relating to notification and other remedies and requirements
or fails to maintain adequate records and necessary reports as required under
the federal act Section 518-519.
E. If its label does not bear adequate directions for use
and adequate warning against unsafe use.
F. If the labeling is false or misleading.
G. If it is a restricted device and fails to bear required
labeling.
[16.19.14.10 NMAC
– Rp, 16.19.14.10 NMAC, 2/28/2023]
16.19.14.11 RESTRICTED DEVICE (PRESCRIPTION
STATUS):
A. FDA requirements may restrict the sale, distribution, or
use of a device if there cannot be reasonable assurance of its safety and
effectiveness.
B. Prescription status devices are determined on the basis
of its intended use and whether or not the device can be adequately labeled as
usable by the layman (i.e., pacemaker, hearing aids, hear valves, etc.).
C. Labeling must contain certain information such as name of
device, statement of intended use, relevant warnings, precaution, side effects
and contraindications.
D. Labeling of a restricted device, other than surgical
instruments, shall bear:
(1) "CAUTION: Federal law restricts
this device to sale by or on the order of a ______:, physician, dentist,
veterinarian, or with the descriptive designation of any other practitioner licensed
by the laws of this State to prescribe or use the device in his practice.
(2) The method of its application or
use.
(3) The label meets all other
requirements under CFR Title 21, Section 801.109 (c) and (d) and (e).
[16.19.14.11 NMAC – Rp, 16.19.14.11 NMAC, 2/28/2023]
16.19.14.12 CUSTOM DEVICES:
A. A custom device is one which is sometimes ordered from
manufacturers by practitioners to conform to their own special needs or to
those of their patients (i.e. prosthetic devices, dental devices and specially
designed orthopedic footwear).
B. Custom devices are exempt from performance standards or pre-market
approval requirements; however, they are subject to FDA requirements for
investigational use, banning, restriction of distribution, adulteration and
misbranding.
C. The exemption applied only to devices which are not
generally available in finished form for dispensing, or on prescription, or for
commercial distribution or generally available to other practitioners.
[16.19.14.12 NMAC
– Rp, 16.19.14.12 NMAC, 2/28/2023]
16.19.14.13 PROCEDURE FOR LICENSURE OF BUSINESS FOR
MEDICAL GAS REPACKAGER OR SELLER AND FOR TRANSFER OF OWNERSHIP OF LICENSED
BUSINESSES:
A. An applicant shall submit required application and fee to
the board. Applications for a license or license renewal under this section
shall be made on a form furnished by the board. The board may require such
information as it deems is reasonably necessary to carry out the purposes of
this part.
B. After preliminary approval of a new application for
licensure, an applicant that is located in New Mexico shall submit a request
for inspection and the inspection fee, where applicable, in advance of fourteen
days of the requested date for inspection. All subsequent requests for
inspection shall be submitted in advance of fourteen days of the requested date
for inspection.
C. The license provided for herein shall terminate upon the
sale or transfer of ownership. Operation of a business subsequent to the date
of such transfer or sale without a new application and approval by the board
shall constitute a violation of the law under Subsection I of Section 61-11-14
NMSA 1978, and is subject to the penalties contained in the Pharmacy Act.
[16.19.14.13 NMAC
– N, 2/28/2023]
16.19.14.14 LICENSE
REQUIREMENTS MEDICAL GAS REPACKAGER OR SELLER:
A. Every medical gas repackager or seller, wherever located,
shall be licensed by the board in accordance with the laws and regulations of
this state before engaging in repackaging, distribution or selling of medical
gases in this state.
B. Repackagers and sellers cannot operate from a place of
residence. No primary business location will be operated out of a storage unit.
Use of a storage unit shall be consistent with accrediting body approval and
allowance.
C. Where operations are conducted at more than one location,
each such location shall be licensed by the board.
D. A manufacturer or wholesale drug distributor licensed by
the board may distribute medical gas without the requirement of a separate
medical gas license. Said licensees shall distribute only to an entity licensed
to receive medical gas. A pharmacy, dentist, or licensed prescriber's license
verifies their authority to receive prescription only medical gases.
E. A pharmacy licensed by the board may provide medical gas
pursuant to a drug order, or to nearby emergency medical services, i.e.,
ambulance companies and firefighting organizations in the same state or same
marketing or service area, or nearby licensed practitioners allowed to
prescribe medical gases for use in the treatment of acutely ill or injured
persons; to nearby or contracted nursing homes or home care services; or to
another pharmacy to alleviate a temporary shortage without the requirement of a
separate medical gas license.
F. The Board may prohibit a person or entity from receiving
or maintaining licensure if the person or entity:
(1) has been convicted of any felony for
conduct relating to manufacturing or distribution, any felony violation of
Subsection (i) or (k) of section 301, or any felony violation of Section 1365
of title 18, United States Code, relating to product tampering; or
(2) has been found by the board to have
violated the requirements of this part, or state requirements for licensure.
G. The board shall have the right to deny a license to an
applicant if it determines that the granting of such a license would not be
consistent with the public health and safety.
[16.19.14.14 NMAC
– N, 2/28/2023].
16.19.14.15 MINIMUM
QUALIFICATIONS MEDICAL GAS REPACKAGER OR SELLER:
A. Compliance with federal, state, and local law.
Repackagers and sellers shall operate in compliance with all applicable
federal, state, and local laws and regulations.
B. Every person or entity subject to this part shall meet
the federal requirements to handle medical gas, the Prescription Drug Marketing
Act at 21 U.S.C., Sec. 331 et seq., and any other applicable federal, state, or
local laws and regulations. Said applicants and licensees shall be registered
with the FDA, if required.
C. Every person or entity subject to this part must conform
to the Compressed Medical Gases Guidelines published by the FDA.
D. Personnel. As a condition of receiving and retaining a
license under this part, the licensee or applicant shall require each person
employed in any medical gas related activity to have education, training, and
experience, or any combination thereof, sufficient for that person to perform
the assigned functions in such a manner as to provide assurance that the
medical gas quality, safety and security will at all times be maintained by law.
[16.19.14.15 NMAC
– N, 2/28/2023]
16.19.14.16 MINIMUM
REQUIREMENTS:
A. Written policies and procedures. Repackagers and sellers shall
establish, maintain, and adhere to written policies and procedures, which shall
be followed for the proper receipt, security, storage, handling, repackaging,
labeling, inventory, distribution, quarantine, return or disposition of medical
gases, for identifying, recording and reporting losses or thefts, for
correcting all errors and inaccuracies in inventories, for maintenance of
required drug records in proper form, and handling recalls.
B. The facility shall be of suitable size and construction,
with adequate lighting, environmental control, quarantine, cleanliness and pest
control.
C. The facility shall be secure from unauthorized entry.
D. Recordkeeping. Medical gas repackagers and sellers shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution or other disposition of medical gas.
E. Inventories and records shall be made available for
inspection and copying by Board inspectors for a period of at least three
years.
F. All repackagers or sellers in New Mexico must publicly
display or have readily available all required licenses and the most recent
inspection report administered by the board.
G. Medical gas repackagers shall distribute only to an
entity licensed to receive medical gas. A pharmacy, dentist, or licensed
prescriber's license verifies their authority to receive prescription only
medical gases.
[16.19.14.16 NMAC
– N, 2/28/2023]
16.19.14.17 CHANGE
IN LOCATION OF A MEDICAL GAS REPACKAGER OR SELLER:
Before any person or entity subject
to this part located in New Mexico changes the location of the facility, a new
application shall be submitted to the board, setting forth such changes. Upon
approval and completion of the change, a request for inspection will be
submitted to the board. There will be no charge for the new application, but
the inspection will carry the same fee as applies for a new facility
inspection.
[16.19.14.17 NMAC
– N, 2/28/2023]
16.19.14.18 TRANSFER
OF OWNERSHIP:
A transfer of ownership occurs upon.
A. The sale of the facility to another individual or
individuals by the present owner.
B. The addition or deletion of one or more partners in a
partnership.
C. The death of a singular or sole owner.
D. The change of ownership of thirty percent or more of the
voting stock of a corporation since the issuance of the license or last renewal
application.
E. A new license application will be required to be filed in
each of the above circumstances. As stated in the Pharmacy Act, Subsection I of
Section 61-11-14 NMSA 1978, licenses are not transferable, and shall expire on
December 31 of every other year unless renewed.
[16.19.14.18 NMAC
– N, 2/28/2023]
16.19.14.19 PRESCRIPTION
REQUIREMENT:
A. Prescription requirement, in general: A designated
medical gas shall be subject to the requirements of 21 U.S.C. section 353(b)(1)
unless the Secretary of the FDA exercises the authority provided in section
353(b)(3) to remove such medical gas from the requirements of section
353(b)(1), the gas is approved for use without a prescription pursuant to an
application under 21 U.S.C. section 355 or 360b, or the use in question is
authorized pursuant to another provision of this part relating to use of
medical products in emergencies.
B. Oxygen, no prescription required for certain uses: oxygen
may be provided without a prescription for the following uses:
(1) for use in the event of
depressurization or other environmental oxygen deficiency; and
(2) for oxygen deficiency or for use in
emergency resuscitation, when administered by properly trained personnel.
(3) Labeling - For oxygen provided
pursuant to this Subsection B., the requirements of section 353(b)(4) of 21 U.S.C.
shall be deemed to have been met if its labeling bears a warning that the
oxygen can be used for emergency use only and for all other medical
applications a prescription is required.
C. Prescription requirement. Except as provided above,
medical gas sellers shall not supply medical gas to a patient or consumer
without a drug order.
(1) An original or copy of a prescription
drug order must be kept at the licensed location supplying the medical gas.
(2) A prescription drug order shall be
valid for a period of time consistent with the indication for which it was
prescribed. Prescription drug orders shall be maintained for three years and be
readily retrievable and available at inspection.
[16.19.14.19 NMAC
– N, 2/28/2023]
16.19.14.20 REPORT
OF ROBBERY, FIRE AND FLOOD: When a medical gas repackager or seller located in
New Mexico is involved in a robbery, fire, flood or any unusual event in which
medical gases might be missing or damaged, the owner shall immediately file
with the Board, a signed statement of the circumstances of such occurrence and
evidence that local authorities were notified, if applicable.
[16.19.14.20 NMAC
– N, 2/28/2023]
HISTORY OF 16.19.14 NMAC:
Pre-NMAC History:
The material in this part was derived from that previously filed with
the State Records Center and Archives:
Regulation No. 14,
Devices, 11-25-80.
Regulation No. 14,
Devices, 10-24-85.
Regulation No. 14,
Devices, 2-2-87.
Regulation No. 14,
Devices, 7-27-90.
History of Repealed Material: 16.19.4 NMAC, Devices filed 3/30/2002, was
repealed and renamed as 16.19.14 Devices; Medical Gas Repackers and Sellers,
effective 2/28/2023.
Other History:
16 NMAC 19.14,
Pharmacists - Devices, filed 02-02-1996, reformatted and renumbered to 16.19.14
NMAC, Devices, effective 03-30-2002.