WebCompleted self-inspection forms must be retained on-site at the drug outlet and be readily retrievable by a Board Compliance Officer. The purpose of the self-inspection is to ensure the pharmacy is in compliance with all state and federal laws and rules governing the practice of pharmacy. WebSelf-Inspection. Worksheet. Do. not. send. to. the. c. ommission. office. The primary objective of this report, and your self-inspection, is to provide an opportunity to identify and correct areas of non-compliance with state and federal law. This worksheet does not replace U.S. Pharmacopeia (USP) <795> Pharmaceutical Compounding – Sterile ...
1 Pharmacy Rules/Regulations by State for Compliance …
WebApr 13, 2024 · The book’s second chapter is devoted to compounding. Here are three highlights from that chapter: 1. “The power of compounded interest is unmatched by … WebSterile Compounding Self-Inspection Addendum . DOH 690-296 (February 2024) Page 4 of 41 . Compliant # USP Reference Notes/Corrective Actions Yes No N/A ☐ ☐ ☐ 13 . Personnel demonstrate proficiency of proper hand hygiene, garbing and consistent cleaning procedures in addition to didactic evaluation of aseptic media fill and glove tip kaiser chiefs only no 1
Oregon Board of Pharmacy : Drug Compounding : State of Oregon
WebNon-Sterile Compounding Inspection Form 6 . Master Compounding Formulation Record . Citation Question Yes No NA . USP 795 NAC 639.67019 All records are maintained for a minimum of 2 years. A master formulation record is available for review. A master formulation record is followed each time the specific formulation is compounded. WebFor inspections of sterile compounding pharmacies that ship across state lines, (STATE) will utilize: Universal Inspection Form State Inspection Form o If selected, state must submit its sterile compounding inspection form that will be cross-walked by NABP. Page 2. III. (STATE) agrees to inspect pharmacies that ship sterile compounded products ... WebAug 13, 2024 · Sections 503A and 503B and Their Differences. Section 503A of the FD&C Act applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility. Section 503B applies to human drug compounding within an … kaiser chiefs how 2 dance