Healthcare Pharmacy Manual Addendum

HEALTHCARE PHARMACY MANUAL ADDENDUM

PARTIES AND EFFECTIVE DATE

This Pharmacy Manual Addendum (the Addendum) amends and supplements the Pharmacy Services Agreement and existing Pharmacy Manual between:

Healthcare Facility Legal Name:

Pharmacy Contractor Legal Name:

Effective Date:

PURPOSE AND SCOPE

Purpose: This Addendum updates specific sections of the Pharmacy Manual to reflect current regulatory, operational, and clinical requirements applicable to the delivery, dispensing, storage, and documentation of pharmaceuticals provided to patients of the Healthcare Facility by the Pharmacy Contractor.

Scope: The revisions set forth in this Addendum apply to all personnel, subcontractors, and agents of the Pharmacy Contractor and the Healthcare Facility engaged in pharmacy-related functions, including dispensing, compounding, procurement, controlled substances handling, returns, and recordkeeping.

AMENDMENTS TO MANUAL SECTIONS

The following Manual sections are hereby amended as indicated. Where specific policy language is replaced, the new language is set forth below. Where a section is supplemented, the additional requirements are appended.

1. Formulary and Therapeutic Interchange: The Pharmacy Contractor shall maintain a formulary that aligns with the Healthcare Facility's therapeutic guidelines. Specific formulary changes to be adopted by the Pharmacy Contractor:

2. Dispensing and Labeling Requirements: The Pharmacy Contractor must ensure all dispensed medications include required patient name, medication name, strength, directions, lot number, expiration date, and facility-specific labeling per the following amendments:

3. Controlled Substances Handling: The Pharmacy Contractor shall adopt the Facility's controlled substances audit schedule, chain-of-custody documentation practices, and loss/theft reporting procedures. The following specific controls are added:

4. Returns, Recalls, and Disposition: Returned medications, recalled items, and expired inventory shall be processed in accordance with the Facility's return policy. The Pharmacy Contractor shall document disposition and provide notification within: days of receipt of recall notice.

QUALITY ASSURANCE, AUDIT AND RECORDKEEPING

Documentation: The Pharmacy Contractor shall retain dispensing records, inventory logs, compounding documentation, controlled substance logs, and reconciliation reports for a minimum of years or as required by applicable law, whichever is longer.

Audit Rights: The Healthcare Facility retains the right to audit, inspect, and copy records related to services provided under the Pharmacy Manual and this Addendum upon days' written notice, except in cases of suspected diversion or patient safety incidents where no notice is required.

STAFFING, CREDENTIALING, AND TRAINING

The Pharmacy Contractor shall ensure all pharmacists, pharmacy technicians, and other staff performing services at the Facility meet the credentialing and competency requirements specified in the Manual. Required documentation to be maintained includes current licensure, certifications, background checks, and training records. Specific additional training topics required by the Facility:

CONFIDENTIALITY, PRIVACY, AND HIPAA COMPLIANCE

The Pharmacy Contractor and its agents shall comply with all applicable privacy and security laws and the Facility's privacy policies. The Pharmacy Contractor shall implement administrative, physical, and technical safeguards to protect Protected Health Information (PHI). The Pharmacy Contractor acknowledges that it is a business associate for purposes of the Health Insurance Portability and Accountability Act where applicable and agrees to the following:

The Pharmacy Contractor certifies that it has implemented training and written policies to address breach response, notifications, and mitigation consistent with state and federal law. Acknowledgment of PHI responsibilities (initials):

INSURANCE, INDEMNIFICATION AND LIABILITY

Insurance: The Pharmacy Contractor shall maintain insurance coverage including professional liability, general liability, and cyber/privacy liability in amounts not less than:

Professional Liability:

General Liability:

Cyber/Privacy Liability:

Indemnification: The Pharmacy Contractor shall indemnify, defend, and hold harmless the Healthcare Facility, its officers, directors, employees and agents from and against any claims, liabilities, losses, damages, costs and expenses (including reasonable attorneys' fees) arising out of the Pharmacy Contractor's performance of services, breach of this Addendum, negligence, willful misconduct, or violation of law.

TERMINATION AND AMENDMENT

Termination for Cause: Either party may terminate this Addendum for material breach that remains uncured after days' written notice.

Amendment: All amendments to this Addendum must be made in writing and executed by authorized representatives of both parties.

NOTICES

ADDITIONAL PROVISIONS

Governing Law: This Addendum shall be governed by and construed in accordance with the laws of the state of , excluding conflict-of-law rules that would apply the laws of another jurisdiction.

Severability: If any provision of this Addendum is found to be invalid or unenforceable, the remainder shall continue in full force and effect.

Expiration of Addendum: Unless earlier terminated in accordance with this Addendum, this Addendum shall expire on:

ATTACHMENTS AND IMPLEMENTATION

Attached Documents: The following attachments form part of this Addendum and take precedence over conflicting Manual provisions where applicable. Indicate attachments included:

CERTIFICATION

By signing below, each party certifies that it has the authority to execute this Addendum, that it has reviewed the amendments and attachments, and that it will comply with the terms set forth herein. Each party acknowledges that failure to comply with the amended Manual provisions may result in corrective action consistent with the Pharmacy Services Agreement.

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