Manufacturer Wholesalers Supervisor

Manufacturer, Repackers, Wholesalers Supervisor

The establishment owner and the designated supervisor share legal responsibility for compliance with Federal and State laws.
The supervisor is considered the knowledgeable authority and remains responsible even when not physically present.
A supervisor can only be designated at one full-time facility and cannot delegate their responsibilities.
His/her role must be an active one

Recordkeeping: Maintain accurate records of all prescription drug purchases, distributions, and repackaging/manufacturing activities.
Drug Integrity: Remove misbranded, adulterated, outdated, or improperly labeled drugs from inventory.
Storage: Ensure proper storage to prevent loss or deterioration.
Security: Limit access to areas containing prescription drugs and devices.
Distribution Control: Prevent unauthorized sales; verify recipients with the NY State Board of Pharmacy(518-474-3817 ext. 130).
Compliance Communication: Inform subordinates—verbally and in writing—about relevant State and Federal laws.
GMP Compliance: For manufacturers/repackagers, ensure adherence to FDA Good Manufacturing Practices.
PDMA Compliance: Ensure full compliance with the Prescription Drug Marketing Act of 1987.
Relocation Notice: Notify the Board of Pharmacy at least 30 days before any address change.

Individuals unable or unwilling to fulfill these responsibilities should not accept the supervisor role.

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