In State and Nonresident Outsourcing Facilities
Supervising Pharmacist Responsibilities (Pharmacist in Charge)
Responsibility for conformance with all Federal and State laws and regulations applicable to the conduct of an outsourcing facility is placed upon the ownership of the establishment and upon the individual that is designated as the supervising pharmacist. Both the owner (and corporate officer) and the designated supervisor sign the application for the registration of the establishment. It is the supervising pharmacist 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 supervising pharmacist oversees the practice of licensed and unlicensed persons and insures that no one engages in unlawful activity. Not only is the supervising pharmacist responsible for the acts of others but his/her responsibility continues even during times when he/she is not physically present.
A supervising pharmacist 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 supervising pharmacist 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 responsibilities 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 all products compounded at that facility.
- Submit a report every six months identifying all drugs compounded in the previous six months.
- Eliminate from stock all misbranded and adulterated drugs including outdated and improperly labeled drugs.
- Insure that all drugs are compounded under the personal supervision of a licensed pharmacist.
- 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 518-474-3817 ext 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.
- Assure complete compliance with the Drug Quality & Security Act 2013 (Federal).
- Notify the Board of Pharmacy of establishment address changes 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 pharmacist in charge.