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Repackaging of prescription and non-prescription drugs

If drugs are repackaged into smaller, ready-to-dispense quantities from larger bulk containers, a physician,
nurse practitioner, dentist (for his/her dental patients) or pharmacist must be on the premises to supervise the repackaging and labeling.

The drugs must be placed in tight, light resistant, child resistant containers with proper labeling. The label must contain the name and address of the health department, the drug name, strength and dosage form (capsule, tablet, etc), quantity, the name of the distributor/manufacturer, the lot number from the bulk container and the expiration date. The expiration date is limited to one year from the date the product is repackaged or the distributor's/manufacturer's expiration date, whichever is the shortest dating.

A log must be maintained documenting the repackaging of all drugs. This log must include the date of repackaging, the drug name, strength and dosage form, quantity per bottle, the number of units repackaged, expiration date of the repackaged product, and the initials of the physician, nurse practitioner, dentist or pharmacist who supervised the repackaging.

Any repackaged drug, prescription or non-prescription, must be dispensed by a physician, nurse practitioner, or dentist (for his or her dental patients) with appropriate documentation and patient labeling.

Last Updated: 07-31-2013

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