[PDF]News New Jersey State Board of Pharmacy - National ...
www.nabp.net/.../nj102014....National Association of Boards of Pharmacy
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, October 15, 2014
Must Read: New Jersey State Board of Pharmacy October 2014 Newsletters Contains Summary of Rule Changes Relating to Compounding
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One of the new provisions states:
N.J.A.C. 13:39-11.19(g) prohibits opened single-dose ampules used in the compounding of sterile preparations from being stored for any period of time.
If I am reading this correctly, the vials may not be stored for "any period of time," but, apparently, after breaching the original quality attribute of sterility and apyrogenicity, the dosage form you MAKE with the vial CAN be stored?
This does not make sense.
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