In State Manufacturers, Repackers, Wholesalers
Responsibility for conformance with all Federal and State laws and regulation applicable to the conduct of a manufacturer, repacker or wholesaler (depending on registration) is placed upon the ownership of the establishment and upon the individual that is designated as the supervisor. Both the owner (or corporate officer) and the designated supervisor sign the application for the registration of the establishment. It is the supervisor who is looked upon as the knowledgeable person who will direct and control the State and Federal compliance and other professional functions at the establishment The supervisor oversees the practice of licensed and unlicensed persons and insures that no one engages in unlawful activity. Not only is the supervisor responsible for the acts of others but his/her responsibility continues even during times when he/she is not physically present.
A supervisor may be designated at only one facility where he/she is employed full time. His/her role must be an active one in the conduct of the establishment's activities and not a passive one.
He/she MAY NOT assign this responsibility to others.
He/she must be aware of all laws and regulations pertaining the establishment's activities and must instruct and direct others in order to insure full compliance. When a supervisor ceases to serve in that capacity, he/she should notify the Board of Pharmacy immediately in writing and indicate the date of termination of duties. It will be the responsibility of the ownership to designate an appropriate successor.
The responsibility of the supervisor include but are not limited to the following:
- Keep in proper form all records required relating to the purchase and distribution of all prescription drugs (including controlled substances and devices) and all products manufactured or repacked at that facility.
- Eliminate from stock all misbranded and adulterated drugs including outdated and improperly labeled drugs.
- Provide for the proper storage of drugs in order to prevent loss or deterioration.
- Assure security and limited access to all areas holding prescription drugs and devices.
- Insure against all unauthorized sales or distribution of prescription drugs to establishments or professionals not authorized to receive such items. Verification must be obtained from the New York State Board of Pharmacy office at 518-474-3817ext 130.
- Issue verbal and written notice to each of his/her subordinates concerning the laws, regulations and rules (State and Federal) to maintain full compliance.
- For repackagers and manufacturers- assure that all Good Manufacturing Procedures as outlined by the FDA are followed.
- For all M/W registrations- assure complete compliance with the Prescription Drug Marketing Act of 1987 (Federal).
- Notify the Board of Pharmacy of establishment address change not less than 30 days prior to the expected date of relocation.
A supervisor who is unable or unwilling to assume the responsibility of the title should not accept appointment as supervisor