Pennsylvania: Summary of Important Pharmacy-Related Rules, Regulations, Statutes, and Practices That Apply to Practice of Pharmacy

GENERAL CONSIDERATIONS

Board of Pharmacy

• Background

  • The Board governs and regulates all aspects of pharmacy practice.

  • It is part of the Pennsylvania Department of Health.

• Consists of

  • Commissioner of Professional Occupational Affairs.

  • Director of Bureau of Consumer Protection in Office of Attorney General.

  • 2 at large (nonpharmacist members).

  • 5 pharmacists.

• Terms

  • 6 years

• Appointments

  • By governor

• Required meetings

  • At least once every 2 months.

Pharmacy License (Permit)

Each licensed pharmacy must have a Board-issued permit indicating:

• Pharmacy name

• Pharmacy address

• Owner name

• Pharmacist manager name

Pharmacist on Duty

The prescription department is open only when a licensed pharmacist is present, or during a pharmacist’s 30-minute break time:

• Pharmacist must remain on premises.

• Pharmacist must be reachable in event of emergency or for counseling.

• During pharmacist break time, the prescription department may:

  • Accept a new prescription order

  • Fill prescriptions, but they must be checked by licensed pharmacist prior to dispensing

  • Provide completed prescriptions to patient, assuming they have been checked by pharmacist

Pharmacy Name or Owner Change

New license (permit) required; must file application within 30 days of change.

Closing a Pharmacy

• Permit must be returned to Board.

• Board must be notified regarding location of prescription files and nonproprietary drugs.

• If 30 days transpire, Board must give prior approval to sell, transfer, or dispose of these.

Change of Pharmacist Manager

• Notify Board within 15 days. (New person approved, if there is no Board objection, within 30 days.)

• Board may extend replacement period to 30 days, if requested.

• Only one pharmacy per pharmacist manager. Where pharmacy owner has difficulty finding replacement, then there may be a 60-day (Board approval required) extension to find a new pharmacist manager.

Interns

• Licensed by Board.

• Only work under direct supervision of a licensed pharmacist.

• If licensed pharmacist not on duty, intern may not be in pharmacy department.

• May do compounding procedures under direct supervision of licensed pharmacist.

Technicians

• May assist licensed pharmacist:

  • Work on pharmacy department inventory.

  • May count and pour.

  • May generate labels.

  • May work on pharmacy records and patient records.

  • May work on parenterals that need reconstitution.

• May not:

  • Accept or transcribe new or refill prescriptions.

  • If licensed pharmacist not on duty, may not be in pharmacy department.

  • Perform any duties that necessitate judgment or independent decisions.

• Allowed functions/responsibilities must be explained; there must be training; there must be a written set of duties/instructions/protocols.

• The written protocols must be prepared by pharmacist manager; list each technician’s duties; dated and signed by technician and pharmacist manager.

Supplies

• Pharmacy department must maintain appropriate drugs and devices to conduct the practice of pharmacy.

• Inventory ...