News for Facilities
Any pharmacy with a current active pharmacy permit may apply on a form provided by the board for registration as a drug donation site. A registered drug donation site may receive eligible donated drugs, transfer such donated drugs to another registered drug donation site, or re-dispense the donated drugs in accordance with § 54.1-3411.1 of the Code of Virginia to patients of clinics organized in whole or in part for the delivery of health care services to the indigent. Drugs collected under the drug donation program may not be dispensed to any other patient, sold, or otherwise distributed except as authorized in regulation. Drugs may only be accepted by a registered drug donation site under the following conditions: the official compendium storage requirements shall be assured; drugs shall be in manufacturers' original sealed containers or in sealed individual dose or unit dose packaging , or better, as set forth in § 54.1-3411.1; drugs shall bear an expiration date that is not less than 90 days from the date the drug is donated; and the drugs shall not have been adulterated or misbranded. The following drugs shall NOT be accepted by a drug donation site: drugs in Schedule II-V (examples include most drugs for severe to moderate pain, anxiety, sleep disorders, and stimulants); drugs determined to be hazardous for donation based on the pharmacist's professional judgment, experience, knowledge, or available reference materials; drugs that may only be dispensed to a patient registered with the drug manufacturer under a restricted distribution system; and drugs that have been previously compounded.
News for Medical Equipment Suppliers
FDA announces the availability of draft guidance for industry entitled "Current Good Manufacturing Practice (CGMPs) for Medical Gases."
The draft guidance may be downloaded at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf or http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0163-gdl0001.doc.
The notice of availability is at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-11073.pdf
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