Sop for compounding pharmacy
Department of Veterans Affairs VHA DIRECTIVE 1108.06(2 ...
Compounding Pharmacy. A compounding pharmacy is licensed with a State Board of Pharmacy and operating in conformance with applicable Federal laws and State laws regulating its practice. It is managed by licensed pharmacists, engaged in the act of preparing, mixing, assembling, labeling and packaging a drug or device as the
[PDF File]An Overview of Standard Operating Procedures (SOPs)
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9. SOP for Patients Counseling 10.SOP for Counseling of Handicapped Patients 11.SOP for Compounding of Medicines 12.SOP for Procurement, Dispensing and Distribution of Narcotic Drugs and Poisons. 13.SOP for Disposal of Expired Drugs 14.SOP for Clinical Ward Round 15.SOP for Training of Intern Pharmacists 16.SOP for Continuing Education
[PDF File]SOP-15: Investigational Product Management
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Version: 3.0 OSUWMC COM -CTMO SOP-15 Effective Date: 01-JUL-2017 Investigational Product Management Page 3 of 8 . Any research study that requires drug compounding is required to use IDS. IDS will make arrangements for sterile drug compounding.
Columbia River Pharmacy LLC dba Malley’s Compounding ...
Pharmacy, OBA Malley's Compounding Pharmacy, from August 12, 2019 to August 16, 2019. Please accept this letter as the Pharmacy's response to the observations raised ... Please see updated SOP 14 ...
[PDF File]Personnel Hygiene and Gowning Requirements: How the ...
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After compounding is complete and personnel exit the cleanroom/ compounding area, all garb items, except the gown, must be disposed of. For re-entry into the cleanroom/compounding area, don new garb (except the gown as previously mentioned) and perform hand hygiene. Additional Provisions for High-Risk Compounding
[DOCX File]VA Northern California Health Care System
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Pharmacy staff that only assist IDS pharmacist by preparing or compounding an investigational drug (e.g., intravenous (IV) admixture) according to local Pharmacy Service SOP’s, and are performing within their usual scope of duties, do not need to complete the Human Subject Protection training.
[PDF File]TITLE : PROCEDURE STORING CHEMICALS COMPOUNDING PRACTICES (HD)
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RELATED STANDARD OPERATING PROCEDURES SOP CODE SOP TITLE USA – NS – P0.1.1.0 Preamble – Implementing – Standard Operating Procedures – Compounding Practices USA – NS – P0.2.1.0 Preamble – Customizing – Standard Operating Procedures – Compounding Practices
[PDF File]Broad Comparison of USP 795: Nonsterile Compounding
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Compounding Space January 2014 Shall have adequate space Compounding environment is suitable Separate areas for sterile and non-sterile compounding Compounding done in clean and sanitized area dedicated to compounding June 2019 Space specifically designated for compounding SOP to describe method of designation (i.e. visible perimeter)
[PDF File]Compounding Task Force Meeting Minutes
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Hazardous Drug Risk Assessment in the Compounding Pharmacy (can be found at learn.nuaire.com Trip wanting to see if pharmacies are preparing for December 2019? ... • Assess relevant Standard Operating Procedures (SOP) 2/19/2018 2 . HD Compliance Officer Hazardous Drugs - Handling in Healthcare Settings. United States Pharmacopoeia Web Site.
[PDF File]Sterile Compounding of Hazardous Drugs
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Compounding Areas - Design1 Areas where hazardous drugs are handled must: Be restricted to authorized personnel Located away from break rooms/highly populated areas Have prominent sign outside of entrance designating hazard Dedicated area for unpacking Negative pressure or neutral/normal NOT in sterile compounding areas
[PDF File]The Revised USP Sterile Compounding Standards
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Standard Operating Procedures USP emphasizes standard operating procedures (SOPs) in this revision by pulling them into their own dedicated section (17). Facilities preparing CSPs are required to develop SOPs for the compounding process and other supporting activities. There are 32 references to SOPs throughout the standards, which specify aspects
[PDF File]USP Guidelines For Standard Operating Procedures ...
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As defined in USP , any pharmacy that engages in the practice of compounding is required to have Standard Operating Procedures (SOP) in place to state how different areas of practice are handled. As stated in USP , all significant procedures in the compounding area should be covered by written standard operating procedures (SOPs).
[PDF File]USP797: Environmental Testing Plan
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environment for compounding CSP’s., especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSP’s. • It is useful for evaluating facility and work surface cleaning and disinfecting procedures and
[DOCX File]Home - Northeast Pharmacy
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The purpose of this SOP is to establish minimum safety standards and requirements environmental and safety controls used in non-sterile HD compounding Responsibility It is the responsibility of the Designated Person to ensure this procedure meets local, state, and federal regulations as required
[DOC File]Non-Sterile Compounding
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California Board of Pharmacy, Business and Professions Code Chapter 9, Division 2, Article 4.5, sections 4005, 4036, 4037, 4052, and 4157. STANDARD OPERATING PROCEDURES. 1. QUALITY ASSURANCE OFFICER. Responsibility: The pharmacist-in-charge and/or the support staff are responsible for this procedure. Purpose:
[PDF File]Cleaning the Compounding Pharmacy
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Quality Through SOP’s and Cleaning Process Control The quality of any compounded sterile preparation (CSP) is the end result of every one of many individual processes functioning correctly at all times. Failure and disaster occurs when processes do not consistently produce their intended outcomes. Cleaning the Compounding Pharmacy (CP) 1.
[DOCX File]NCCP Template SOPs
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The scope of this SOP includes the handwashing process to be followed by staff upon entry/ exit of any area where aseptic compounding or clean procedures related to aseptic compounding may occur. This may include the change rooms, the preparation rooms and the clean rooms in …
[DOC File]SCOPE OF PRACTICE FOR PHARMACY SUPPORT PERSONNEL
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A pharmacy technician may provide or perform the following services or acts under the direct supervision of a pharmacist in a pharmacy and in accordance with standard operating procedures approved by the responsible pharmacist: assist with the compounding, manipulation or preparation of a non-sterile or sterile medicine or scheduled substance;
[DOC File]Hazardous Drugs SOP Template - Duke University
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A customized SOP is required for all drugs on the particularly hazardous substances list. All investigational drugs will be handled as hazardous drugs unless adequate information exists to exclude them. This SOP focuses on hazardous drug use in research labs. For further information on hazardous drug use at Duke (especially if your use is ...
[PDF File]Parenteral Nutrition Pharmacy Standard Operating Procedures
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SBUH Parenteral Nutrition Pharmacy: Standard Operating Procedures 4 | P a g e The IV Bench Pharmacist on the evening shift is responsible for the receiving of the PN bags from the CAPS driver. They must sign off on the CAPS packaging sheet, and then compare the top sheet (sample label) of the Order Packet to the actual label on the
[DOCX File]PURPOSE & INTENT - Compounding Formulas and Technical …
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All suggested Standard Operating Procedures should be validated, approved and authorized for use by the end-user licensed pharmacist prior to use. ... All trained and authorized compounding personnel are responsible to perform this SOP. Purpose. ... Ensure that airborne release of pesticides does not occur inside of the pharmacy.
[PDF File]RESEARCH PHARMACY STANDARD OPERATING PROCEDURES (SOP ...
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Pharmacy Service 119PR-15-005. December 12, 2014. RESEARCH PHARMACY STANDARD OPERATING PROCEDURES (SOP) Controlled Substances Utilized in Clinical Research. 1. PURPOSE: To establish a standard operating procedure for the research pharmacy’s handling of controlled substances utilized in clinical research at the South Texas Veterans Health Care ...
[PDF File]GUIDANCE DOCUMENT for Pharmacy Compounding of Non-sterile ...
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Page 4 Acknowledgements PEI College of Pharmacists wishes to acknowledge that this guidance document was adapted with permission from the “Guidance Document for Pharmacy Compounding of Non-sterile Preparations – Companion to the Model Standards for Pharmacy Compounding of Non-sterile Preparations, published by the National Association of Pharmacy Regulatory Authorities (NAPRA) for ...
[DOCX File]CriticalPoint: Home
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Jul 29, 2014 · The compounding employee will gently roll the pad each of four fingers and thumb from one hand onto the contact plate with sufficient force to make slight depressions in the agar. ... The person reading the plates will inform the Pharmacy Manager (designee) immediately in the event the results of the GFS exceed the designated action level. ...
[PDF File]Standard Operating Procedures - Home - Gates Healthcare ...
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Attachment 1 – Process Change Form-may or may not involve a change in SOP . Attachment 2 – SOP Review Form . Attachment 3 – SOP Number Log ... Compounding Pharmacy Technician . Job Description – Compounding Pharmacy Intern . Job Description – Certified Compounding CQI Pharmacy Technician . Page 2 of 7.
[DOCX File]Duke Standard Operating Procedure Template
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This SOP covers receipt, restocking, storage, dispensing and accounting for the study drugs dispensed in the study. This SOP does not cover the preparation of the study drugs by the manufacturer, sponsor or Clinical Site research pharmacy; drugs are supplied in sealed, prepackaged bottles and no additional preparation is required.
[PDF File]UNIVERSITY HOSPITAL – DEPARTMENT OF PHARMACY POLICY AND ...
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Pharmaceutical care is delivered from the Main Pharmacy, which includes the Sterile Compounding Area, Antineoplastic and Hazardous Drug Compounding Area, and the Investigational Drug Service; from the Satellite Pharmacies located in the Operating Room, Ambulatory Surgery Center, and
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