NMBOP: 16.19.09 MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS Flashcards
“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.
“Manufacturers”
means the person or company who manufacturers a drug in its’ finished dosage form.
“Packager” or “Packer”
means a person or firm, other than a wholesaler, who distributes drugs.
“Distributor”
means the original selling agent, other than a wholesaler, who distributes drugs.
“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
Q: What are the minimum standards for manufacturing establishments and repackaging firms?
A: The following standards apply:
1. All drugs and chemicals must conform to the New Mexico Drug and Cosmetic Act and be stored, preserved, and disposed of according to laws regulating drug labeling and manufacture. Drugs and chemicals requiring refrigeration must be stored at proper temperatures.
2. Manufacturers must conform to current good manufacturing practices as outlined in Title 21, CFR, Subsection 211.1 to 211.208. Definitions and interpretations from Section 201 of the Federal Food and Drug Act are applicable.
3. Manufacturers must adhere to the United States Pharmacopeia’s guidelines for packaging, storage, and distribution of pharmacopeial articles.
4. Stability of dosage forms must be demonstrated using adequate methods. Monograph assays used for stability testing should differentiate between intact drug molecules and their degradation products, considering physical appearance changes.
5. Stability studies must include “real-time” long-term tests under specific temperatures and relative humidities reflecting storage and shipping conditions. Labels must reflect temperature and humidity effects and allow for expected seasonal excursions.
6. All individuals in the distribution or dispensing chain must follow the manufacturer’s directions.
Q: What are the minimum requirements for handling radioactive pharmaceuticals in manufacturing establishments?
A: Radioactive pharmaceuticals require:
1. Specialized handling and testing techniques to ensure accurate results and minimize hazards.
2. Additional minimum equipment and accessory standards:
- Fume hood: minimum of 30 inches
- Laminar flow hood
- Dose calibrator
- Lead-lined refrigerator
- Mettler balance
- Spectrophotometer
- Drawing station (lead glass and lead)
Q: What glassware is required for manufacturing radioactive pharmaceuticals?
A: Required glassware includes:
1. 3 beakers: 50 ml each
2. 3 beakers: 150 ml each
3. 1 beaker: 500 ml
4. 2 volumetric flasks: 50 ml each
5. 6 volumetric flasks: 100 ml each
6. 2 graduated cylinders: 10 ml each
7. 2 graduated cylinders: 100 ml each
Q: What additional equipment, supplies, and references are needed for radioactive pharmaceutical preparation?
A: Additional requirements include:
1. Radiochromatographic strip scanner and/or well counter.
2. Supplies:
- Disposable syringes: 1, 3, and 5 cc
- Multidose vials: 10, 20, and 30 cc
- Disposable alcohol swabs
- Disposable gloves
3. Reference books:
- American Hospital Formulary Service
- National Formulary
- United States Pharmacopoeia
Q: What are the space requirements for radioactive pharmaceutical manufacturing or preparation areas?
A: The space must be:
1. An undivided area of not less than 240 square feet for the hot lab and storage area.
2. The area must contain an adequate sink with hot and cold water facilities.
Q: What is required for a manufacturer shipping dangerous drugs into New Mexico or distributing them in the state?
A: No manufacturer shipping dangerous drugs into New Mexico or selling/distributing dangerous drugs in the state through any person or media, other than a licensed wholesaler, shall conduct the business of selling or distributing dangerous drugs without obtaining an out-of-state drug license from the Board.
Q: How should an application for an out-of-state drug distributor’s license be made?
A: Applications must be made on a form furnished by the Board of Pharmacy. The Board may require information it deems 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.
Q: What are the fees and renewal requirements for an out-of-state drug distributor’s license?
A: The license fee shall be as specified in 16.19.12 NMAC, Fees, and the license shall be renewed annually before the last day of December each year.
Q: Can a person act as a principal or agent for an out-of-state manufacturer, wholesaler, or distributor without a license?
A: 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.
Q: What must a person do if acting as a principal or agent for a licensed manufacturer, wholesaler, or distributor?
A: Any person acting as principal or agent for a manufacturer, wholesaler, or distributor who is licensed by the Board and who possesses or distributes dangerous drugs must register as a principal or agent for the licensed manufacturer, wholesaler, or distributor.
