Compounding Pharmacist

The 503A Compounding Pharmacist is responsible for providing pharmacist oversight of the compounding department and ensuring compounded preparations are produced, verified, and released in accordance with applicable federal and state pharmacy regulations, USP standards, company policies, prescriptions, formulations, and established quality procedures.

This position provides direct oversight of compounding personnel and workflow and serves as the pharmacist responsible for the final review and release of compounded preparations before they proceed to fulfillment and dispensing.

The ideal candidate has strong knowledge of sterile and non-sterile compounding, quality assurance, formulation review, documentation, and regulatory compliance within a 503A compounding pharmacy environment.

Second shift. Monday through Friday 2:00 pm to 10:30 pm

• Provide pharmacist oversight of daily sterile and non-sterile compounding operations.
• Supervise and support compounding technicians and other authorized compounding personnel.
• Ensure compounded preparations are prepared according to approved master formulation records, prescriptions, standard operating procedures, and applicable USP requirements.
• Monitor workflow, production priorities, staffing, and workload within the compounding department.
• Verify that appropriate ingredients, components, equipment, supplies, and documentation are available before compounding begins.
• Ensure personnel follow proper garbing, hand hygiene, aseptic technique, cleaning, sanitation, and contamination-control procedures when applicable.
• Identify workflow or quality concerns and stop compounding activities when patient safety, product quality, or regulatory compliance may be compromised.
• Assist with training and competency assessment of compounding personnel.
• Promote a culture of accuracy, accountability, cleanliness, patient safety, and continuous quality improvement.

• Perform final pharmacist verification of compounded preparations prior to release.
• Confirm the compounded preparation matches the patient-specific prescription and approved formulation.
• Verify calculations, ingredients, concentrations, quantities, dosage forms, routes of administration, and labeling for accuracy.
• Review compounding records and required documentation for completeness before releasing product.
• Verify appropriate beyond-use dating, storage conditions, auxiliary labeling, and packaging.
• Conduct or confirm required visual inspection of compounded preparations when applicable.
• Confirm that required in-process checks, pharmacist checks, testing, or quality-control requirements have been completed before product release.
• Place preparations on hold when discrepancies, documentation issues, quality concerns, testing failures, or other deviations are identified.
• Approve product for release only when all applicable requirements have been satisfied.
• Document pharmacist verification and release according to company procedures.

• Maintain compliance with applicable requirements governing 503A pharmacy compounding.
• Support compliance with applicable USP standards, including USP Chapter 795, USP Chapter 797, and USP Chapter 800, as applicable to pharmacy operations.
• Ensure compounded preparations are produced pursuant to appropriate patient-specific prescription requirements and company procedures.
• Review compounding documentation for completeness, accuracy, traceability, and compliance.
• Participate in investigations involving compounding errors, deviations, complaints, adverse events, or quality concerns.
• Assist with corrective and preventive actions when deficiencies are identified.
• Ensure ingredients and bulk drug substances used for compounding meet applicable requirements and pharmacy policies.
• Participate in environmental monitoring, cleaning documentation review, equipment qualification, calibration, certification, and other quality activities when applicable.
• Assist with preparation for inspections and audits conducted by regulatory agencies, boards of pharmacy, accreditation organizations, or internal quality teams.
• Maintain knowledge of changes to pharmacy laws, regulations, USP standards, and company procedures that affect compounding operations.

• Review and approve compounding records as required.
• Ensure appropriate lot numbers, expiration dates, quantities, calculations, and ingredient…