N.M. Admin. Code § 16.19.9.8
Current through Register Vol. 35, No. 23, December 10, 2024
Section 16.19.9.8 - MINIMUM STANDARDSA. 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(d) Refrigerator (lead lined)(g) Drawing Station (lead glass and lead)(3) Glassware: (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(6) Reference books: (a) American Hospital Formulary Service(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.N.M. Admin. Code § 16.19.9.8
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