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PS 858

Para establecer la “Ley para la Supervisión sobre Medicamentos Compuestos de Alto Riesgo”; requerir la publicación de informes bianuales por parte de la la Secretaría Auxiliar para Reglamentación y Acreditación de Facilidades de Salud (SARAFS), y la Junta Examinadora de Farmacia sobre la supervisión de las prácticas de preparación de medicamentos compuestos; garantizar una mayor visibilidad sobre las acciones regulatorias para proteger a los pacientes de medicamentos preparados ilegalmente; y otros fines relacionados.

2025-2028 Session

Overview: Bill PS 858 establishes the "Law for Supervision of High-Risk Compounded Medications," requiring biannual reports from the Auxiliary Secretariat for Regulation and Accred

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Bill Summary · PS 858

Overview: Bill PS 858 establishes the "Law for Supervision of High-Risk Compounded Medications," requiring biannual reports from the Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS) and the Pharmacy Examining Board on the supervision of compounded medication preparation practices. The bill aims to provide greater visibility on regulatory actions to protect patients from illegally prepared medications.

Purpose and Intent: The main goal of this bill is to enhance the oversight and regulation of the preparation of high-risk compounded medications in Puerto Rico, with the aim of ensuring patient safety and the quality of these specialized pharmaceutical products.

Key Provisions:
- Establishes the "Law for Supervision of High-Risk Compounded Medications"
- Requires biannual reports from SARAFS and the Pharmacy Examining Board on compounded medication supervision
- Aims to increase transparency and visibility of regulatory actions related to compounded medications

Affected Parties and Impacts: The bill will directly impact the government agencies responsible for regulating and overseeing the preparation of compounded medications, as well as the healthcare providers and pharmacies that compound these specialized products. Patients who rely on compounded medications may also benefit from the increased oversight and transparency.

Procedural and Timeline Considerations: The bill has been referred to one or more committees, indicating it is in the early stages of the legislative process. The specific timeline and next steps will depend on the committee's review and any further actions taken by the legislature.

Compiled from official sources — confirm details with the bill’s official record.

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