TITLE
16 OCCUPATIONAL AND
PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 14 DEVICES
16.19.14.1 ISSUING AGENCY: Regulation and Licensing Department, Board
of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
841-9102.
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16.19.14.1 NMAC - Rn, 16 NMAC 19.14.1, 03-30-02]
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.
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16.19.14.3 STATUTORY AUTHORITY: Section 61-11-6.A.(7) 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.
Section 26-1-18 of the Drug, Device and Cosmetic Act authorizes the Board to
promulgate regulations for the efficient enforcement of the Act.
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16.19.14.4 DURATION: Permanent.
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16.19.14.4 NMAC - Rn, 16 NMAC 19.14.4, 03-30-02]
16.19.14.5 EFFECTIVE DATE: February 15, 1996, unless a different date
is cited at the end of a Section or Paragraph. This Part reformatted for
inclusion into the New Mexico Administrative Code (NMAC) effective 2-15-96.
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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.
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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. [Reserved]
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16.19.14.7 NMAC - Rn, 16 NMAC 19.14.7, 03-30-02]
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)).
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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.
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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.
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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).
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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.
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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: [RESERVED]
Other
History: 16 NMAC 19.14, Pharmacists -
Devices, filed 02-02-96, reformatted and renumbered to 16.19.14 NMAC, Devices,
effective 03-30-2002.