TITLE 16 OCCUPATIONAL AND PROFESSIONAL
LICENSING
CHAPTER 19 PHARMACISTS
PART 9 MINIMUM STANDARDS FOR
MANUFACTURERS AND REPACKAGING FIRMS
16.19.9.1 ISSUING AGENCY: Regulation and Licensing Department - Board
of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
841-9102.
[02-15-1889...02-15-96;
16.19.9.1 NMAC – Rn, 16 NMAC 19.9.1, 03-30-02]
16.19.9.2 SCOPE: All manufacturers, packagers and
distributors, other than wholesalers, of drugs, including radioactive
pharmaceuticals.
[02-15-96;
16.19.9.2 NMAC – Rn, 16 NMAC 19.9.2, 03-30-02]
16.19.9.3 STATUTORY AUTHORITY: Section 61-11-6A(6) NMSA 1978 directs the
Board of Pharmacy to provide for the licensing of drug manufacturers and for
the inspection of their facilities and activities. Section 61-11-6(A) 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, Chapter 26, Article I
NMSA 1978. Pursuant to Section 26-1-18
of the Drug, Device and Cosmetic Act, the Board is authorized to promulgate
regulations for the efficient enforcement of the Act.
[02-15-96;
A, 03-14-98; 16.19.9.3 NMAC – Rn, 16 NMAC 19.9.3, 03-30-02]
16.19.9.4 DURATION: Permanent
[02-15-96;
16.19.9.4 NMAC – Rn, 16 NMAC 19.9.4, 03-30-02]
16.19.9.5 EFFECTIVE DATE: February 15, 1996, unless another date is
specified at the end of a section.
[02-15-96;
A, 03-14-98; 16.19.9.5 NMAC – Rn, 16 NMAC 19.9.5, 03-30-02]
16.19.9.6 OBJECTIVE: The objective of Part 9 of Chapter 19 is to
establish standards for the safe and competent manufacture, packaging,
repackaging and distribution of drugs, including radioactive pharmaceuticals.
[02-15-96;
16.19.9.6 NMAC – Rn, 16 NMAC 19.9.6, 03-30-02]
16.19.9.7 DEFINITIONS: For the purpose of defining Section 26-1-11
A(3) NMSA Comp. the following definitions apply:
A. "Manufacturer" means the steps in the
preparation, propagation, processing or compounding of a drug - the making by
chemical, physical, biological or other procedures of any articles which meet
the definition of drugs and includes manipulation, sampling or control
procedures resulting in the finished dosage form. Manufacture includes all the steps performed on the product
itself, which do not affect intrinsically the safety, purity or potency of the
product.
B. "Manufacturers" means the
person or company who manufacturers a drug in its' finished dosage form.
C. "Packager"
or "Packer" means a person or firm, other than a wholesaler, who
distributes drugs.
D. "Distributor" means the original
selling agent, other than a wholesaler, who distributes drugs.
E. "The
finished dosage form" of a prescription drug is defined as that form of the drug
which is or is intended to be dispensed or administered to the patient and
requires no further manufacturing or processing other than packaging and
labeling.
[03-07-80...08-27-90;
16.19.9.7 NMAC – Rn, 16 NMAC 19.9.7 NMAC, 03-30-02]
16.19.9.8 MINIMUM STANDARDS:
A. The following minimum standards
shall apply to all manufacturing establishments and repackaging firms for which
licenses have been issued by the Board:
(1) All drugs and chemicals used in the
manufacturing process or held for sale shall conform to the New Mexico Drug and
Cosmetic Act and shall be stored, preserved and disposed of as prescribed by
laws regulating the labeling and manufacture of drugs. When necessary, and/or
according to label requirements, all drugs and chemicals which require
refrigeration shall be stored and preserved under proper temperature.
(2) All manufacturers must conform to current
good manufacturing practices as set forth in Title 21, CFR, Subsection 211.1 to
211.208 inclusive. The definitions and
interpretations contained in Section 201 of the Federal Food and Drug Act shall
be applicable.
(3) All manufacturers must conform to (1141)
Packaging, Storage, and Distribution of Pharmacopeial Articles, the United
States Pharmacopeia. These include the
following stability protocols:
(4) Stability of manufactured dosage forms
must be demonstrated by the manufacturer by the use if the methods adequate for
the purpose. Monograph assays may be
used for stability testing if they are stability-indicating (i.e., if they
accurately differentiate between the intact drug molecules and their
degradation products). Stability
considerations should include not only the specific compendial requirements,
but also changes in physical appearance of the product that would warn, users
that the product’s continued integrity is questionable.
(5) Stability studies on active substances
and packaged dosage forms must be conducted by means of “real time”, long-term
tests at specific temperatures and relative humidities representing storage and
shipping conditions experienced in the distribution chain of the climatic zones
of the country or region of the world concerned. Labeling of the packaged active substance or dosage form shall
reflect the effects of temperature, relative humidity, air, and light on its
stability. Label temperature storage
warnings will reflect both the results of the real-time storage tests and also
allow for expected seasonal excursions of temperature during distribution.
(6) All persons in the distribution or
dispensing chain shall comply with the manufacturers directions.
B. RADIOACTIVE
PHARMACEUTICALS
(1) Radioactive pharmaceuticals require
specialized techniques in their handling and testing in order that correct
results may be obtained and hazards to personnel be minimized.
(2) The following minimum requirements must
be met for a manufacturing establishment preparing radiopharmaceutical
products. These requirements are in
addition to the regulatory requirements of the Federal Atomic Energy
Commission, the Federal Food and Drug Administration, the U.S. Public Health
Service regulations and the New Mexico Radiation Protection Act administered by
the Environmental Improvement Agency. Minimum equipment and accessory standards:
(a) Fume hood - minimum of 30
inches
(b) Laminar flow hood
(c) Dose calibrator
(d) Refrigerator (lead lined)
(e) Mettler balance
(f) Spectrophotometer
(g) Drawing Station (lead glass and lead)
(3) Glassware:
(a) 3 beakers 50 ml
(b) 3 beakers 150 ml
(c) 1 beaker 500 ml
(d) 2 volumetric flasks 50 ml
(e) 6 volumetric flasks 100 ml
(f) 2 graduated cylinders 10 ml
(g) 2
graduated cylinders 100 ml
(4)
Radiochromatographic strip scanner and/or well counter
(5) Supplies:
(a) disposable syringes 1,3 and 5 cc
(b)
multidose vials 10, 20 and 30
cc
(c) disposable alcohol swabs
(d) disposable gloves
(6) Reference
books:
(a) American Hospital Formulary Service
(b) National Formulary
(c) United States Pharmacopoeia
(7) Space: The radiopharmaceutical manufacturing or
preparation area shall be an undivided area of not less than 240 square feet
for the hot lab and storage area. The
area shall contain adequate sink with hot and cold water facilities.
[03-07-80...08-27-90;A,
03-14-98; 16.19.9.8 NMAC - Rn & A, 16 NMAC 19.9.8, 03-30-2002]
16.19.9.9 LICENSURE
OR REGISTRATION: Wholesale
distributor and manufacturer distributor or manufacturer.
A. No manufacturer shipping
dangerous drugs into New Mexico or who sells or distributes dangerous drugs in
this state through any person or media, other than a wholesaler who has
obtained a license, shall conduct the business of selling or distributing
dangerous drugs without obtaining an out-of-state drug license from the Board.
B. Applications for an
out-of-state drug distributor's license under this section shall be made on a
form furnished by the Board of Pharmacy.
The Board may require such information as it deems is reasonably
necessary to carry out the purposes of this section. This requirement does not include the licensure of a parent corporation
of a corporation or division.
C. The license fee shall be
as specified in 16.19.12 NMAC, Fees, and shall be renewed annually before the
last day of December each year.
D. No person acting as
principal or agent (detail man) for any out-of-state manufacturer, wholesaler
or distributor who has not obtained a license from the Board shall conduct the
business of selling or distributing dangerous drugs within the state.
E. Any person acting as
principal or agent for any manufacturer, wholesaler or distributor who is
licensed by the Board and who possesses or distributes dangerous drugs, shall
register as principal or agent for the licensed manufacturer, wholesaler or
distributor.
F. Registration of persons
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 purpose of this section,
including, but not limited to, the name and address of the registrant and the
name and address of the manufacturer whose drugs he is selling or distributing.
G. The Board may deny,
revoke or suspend such person's registration for any violation of the State
Drug Laws.
[03-07-80...08-27-90; Rn, 16.19.9.10.7, 03-14-98;
16.19.9.9 NMAC – Rn, 16 NMAC 19.9.9, 03-30-02; A, 12-01-2003]
16.19.9.10 LABELS: Labels for legend drugs in package form
shall conspicuously state the name and place of business of the manufacturer of
the finished dosage form and the name and place of business of the packer or
distributor.
[03-07-80...08-27-90;
Rn, 16.19.9.11.1, 03-14-98; 16.19.9.10 NMAC – Rn, 16 NMAC 19.9.10, 03-30-02]
16.19.9.11 FINISHED DOSAGE FORMS: Where the manufacturer of the finished
dosage form and the packer or distributor are the same person, only the name
and place of business of such persons are required to be on the labels, no
qualifying language is necessary.
[03-07-80...08-27-90;
Rn, 16.19.9.12.1, 03-14-98; 16.19.9.11 NMAC – Rn, 16 NMAC 19.9.11, 03-30-02]
16.19.9.12 FINISHED
DOSAGE FORMS - QUALIFYING LANGUAGE: Where
the manufacturer of the finished dosage form and the packer or distributor are
different persons, the labels shall contain qualifying language that states the
connection such persons have with the drugs: i.e., "Manufactured by
________, distributed by _________, "Manufactured by ____________, for
___________", or other wording which adequately expresses the facts.
[03-07-80...08-27-90; Rn, 16.19.9.13.1,
03-14-98; 16.19.9.12 NMAC – Rn, 16 NMAC 19.9.12, 03-30-02]
16.19.9.13 FINISHED DOSAGE FORMS - CORPORATE
NAME: In the case of a corporation, only the
actual corporate name, which may be preceded or followed by the name of the
particular division of the corporation shall be required. In the case of an individual partnership or
association, the name under which the business is conducted shall be used.
[03-07-80...08-27-90; Rn, 16.19.9.14.1, 03-14-98;
16.19.9.13 NMAC – Rn, 16 NMAC 19.9.13, 03-30-02]
16.19.9.14 FINISHED DOSAGE FORMS - PLACE OF
BUSINESS: If a person manufactures, packs or
distributes a drug at a place other than his principle place of business, the
label may state the principle place of business in lieu of the actual place
where such drug is manufactured or packed or is to be distributed, unless such
statement would be misleading.
[03-07-80...08-27-90;
Rn, 16.19.9.15.1, 03-14-98; 16.19.9.14 NMAC – Rn, 16 NMAC 19.9.14, 03-30-02]
History of 16.19.9 NMAC:
Pre-NMAC History:
Material
in this part was derived from that previously filed with the commission of
public records - state records center and archives as:
Regulation
No. 9, Minimum Standards for Manufacturers and Repackaging, filed 02-07-80;
Regulation
No. 9, Minimum Standards for Manufacturers and Repackaging Firms, filed
10-23-85;
Regulation
No. 9, Minimum Standards for Manufacturers and Repackaging Firms, filed
02-02-87;
Regulation
No. 9, Minimum Standards for Manufacturers and Repackaging Firms, filed
07-27-90.
History
of Repealed Material:
16
NMAC 19.9, Minimum Standards for Manufacturers and Repackaging Firms, filed
03-03-98.
Other History:
Regulation
No. 9, Minimum Standards for Manufacturers and Repackaging Firms, filed
07-27-90 renumbered and reformatted to 16 NMAC 19.9, Minimum Standards for
Manufacturers and Repackaging Firms, filed 02-02-96;
16
NMAC 19.9, Minimum Standards for Manufacturers and Repackaging Firms, filed
03-03-98 - replaced by 16.19.9 NMAC, Minimum Standards for Manufacturers and
Repackaging Firms, effective 06-27-01.