Examples of chemicals sold in ampoules are injectable pharmaceuticals, air-sensitive reagents like tetrakis(triphenylphosphine)palladium(0), hygroscopic materials like deuterated solvents and trifluoromethanesulfonic acid, and analytical standards.
Refrigeration will retard the growth of microbes that may be inadvertently introduced into the vial via the needle.
Multiple drugs may be packaged in the same container such that the different drugs are in contact with each other only under the following conditions: (A) The number of drugs placed in one package cannot exceed the capability of the receptacle to prevent damage to the dosage forms.(B) The quantity dispensed may not be more than a thirty-one-day supply.(2) The counting and repackaging of dosage units in the pharmacy is eliminated, thereby reducing the possibility of human error.
is one who purchases and removes a drug product from the manufacturer's market container or bulk dosage container and places the product into a different container for distribution for human or animal use.
A repackager may or may not take ownership from the manufacturer.
(E) Medications which have been packaged in multi-dose packaging are considered adulterated if returned to the pharmacy for any reason and may not be returned to stock or re-dispensed.
(G) Any pharmacist or pharmacy using multi-dose packaging must implement policies and procedures which will exclude drugs having the following characteristics from such packaging: (1) The U.
Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality, and any remaining contents must be discarded.