6.8 Pharmacy Permits, Inspections & Discipline

Pharmacy Permits, Inspections, and Discipline

PA's permit, inspection, and discipline framework is the enforcement backbone of 49 Pa. Code Chapter 27 and the Pharmacy Act (63 P.S. §§ 390-1 et seq.). Pharmacists and pharmacies are subject to the PA State Board of Pharmacy within the Department of State's Bureau of Professional and Occupational Affairs (BPOA). The Board issues permits, conducts inspections, and disciplines violations.

Pharmacy Permit (49 Pa. Code § 27.11)

A pharmacy permit is required for every location where pharmacy is practiced. Key rules:

• One permit per location: each physical location where pharmacy services are provided must have its own permit
• Separate applications: an applicant for multiple locations submits a separate application for each
• Pharmacist-in-charge (PIC): each pharmacy must have a pharmacist named as the responsible manager; the PIC is identified on the permit
• Application contents: ownership, location, PIC identity, drug storage plans, equipment, security
• Initial inspection: before opening, the Board inspects the location to confirm compliance

Permit Renewal

Pharmacy permits are renewed biennially, expiring on the same cycle as pharmacist licenses in even-numbered years (Sept 30). Late renewal triggers a penalty; failure to renew means the pharmacy cannot lawfully operate. The PIC is responsible for ensuring timely renewal.

Change of Ownership or Location

A change of ownership or change of location requires a new pharmacy permit — the existing permit does not transfer. A change of ownership (e.g., a sale to a new owner) terminates the old permit; the new owner must apply for a new permit and pass a new inspection. A relocation, even a short distance, also requires a new permit and inspection.

Out-of-State Pharmacy Registration

A pharmacy located outside PA that ships, mails, or delivers drugs to PA patients must register with the PA Board of Pharmacy. Out-of-state pharmacies shipping into PA are subject to PA jurisdiction, must comply with PA rules, and must designate an agent for service of process. Failure to register is a violation and may result in disciplinary action and the inability to ship to PA.

Board Inspections

The Board conducts two types of inspections:

• Routine inspections: periodic (announced or unannounced) confirmations of compliance with rules covering recordkeeping, security, drug storage, labeling, controlled substance inventory, and personnel
• For-cause inspections: prompted by a complaint, an incident, or a suspected violation; may be unannounced and may include targeted review of records, controlled substances, and personnel files

Pharmacies must permit Board inspectors access during business hours. The pharmacist-manager must be available or a designated pharmacist must provide access.

Disciplinary Process

When the Board receives a complaint or identifies a violation, the disciplinary process follows:

1. Complaint: filed with the Board by a patient, pharmacist, or other party
2. Investigation: Board investigators review the complaint, interview witnesses, and gather evidence
3. Notice of charges: the Board issues a formal notice with the alleged violations
4. Hearing: a formal administrative hearing before the Board or a hearing officer; the respondent may have counsel, present evidence, and cross-examine witnesses
5. Order: the Board issues a final order with findings, conclusions, and sanctions
6. Appeal: the respondent may appeal to the Commonwealth Court of PA

Grounds and Sanctions

Grounds for discipline under the Pharmacy Act and 49 Pa. Code § 27.64 include:

• Fraud, deception, or misrepresentation in obtaining a license or permit
• Gross incompetence or negligence in practice
• Violation of the Pharmacy Act, controlled substance law, or Board rules
• Criminal conviction of a felony or a drug-related offense
• Drug diversion or theft
• Failure to maintain records or to permit inspection
• Habitual intoxication or drug addiction

Sanctions include:

• Suspension: license or permit suspended for a specified period
• Revocation: license or permit permanently revoked
• Civil penalty: monetary fine
• Reprimand: formal public censure
• Probation: practice under conditions and monitoring

Pharmacy Permit Renewal & Reinstatement

Pharmacy permits renew biennially in odd-numbered years under 49 Pa. Code § 27.31(a) (distinct from pharmacist licenses, which renew in even-numbered years). The permit holder submits the Board form or online renewal with the specified fee. Failure to renew places the pharmacy in lapsed status; the pharmacy may not operate until the permit is restored.

Reinstatement of a pharmacy permit (after lapse, suspension, or revocation) is a Board action separate from pharmacist license reinstatement:

• The owner/permit holder must petition the Board, pay back fees/penalties, and document corrective action.
• After revocation, reinstatement is discretionary and typically requires a new application demonstrating fitness to operate, corrected deficiencies from the order, and sometimes a new inspection before reopening.
• After suspension, the Board may reinstate when all order conditions (policies, staffing, security, CE for responsible pharmacists, civil penalties) are certified complete.
• A pharmacy operating on a lapsed or revoked permit is unlicensed practice and exposes the PIC and owner to discipline.

Do not confuse this with pharmacist license reinstatement (covered in License Renewal, CE & Discipline), which may require re-examination (NAPLEX/PA MPJE), remedial CE, or monitored practice for the individual licensee.