Document_Released

McGuff Compounding Pharmacy
Released and Active Documents for Quality Control

Information that is withheld may indicate a specific product. *

Document Number	Document Title
Withheld	Quality System Policy Manual
Withheld	Management Review
Withheld	Organization Chart Control
Withheld	Quality Plan
Withheld	Facility Inspection Procedure
Withheld	Contract Order Review Procedure
Withheld	Product Development Protocol
Withheld	How to Perform Failure Mode, Effect and Criticality Analysis and Fault Tree Analysis
Withheld	Product Development Protocol for Pharmacy Compounded Product
Withheld	Product Commercial Release Authorization Form
Withheld	Design Phase Review Checklist
Withheld	Design Phase Review and Product Development Approval Form
Withheld	Design Input Evaluation Checklist
Withheld	Formulation and Compounding History Record Checklist, Pharmacy Compounded Products
Withheld	Document Control
Withheld	Computerized Quality Record Documentation Control
Withheld	Document Change Notice Form
Withheld	Deviation to Established Compounding History Record
Withheld	Supplier Selection and Evaluation Procedure
Withheld	Purchasing Procedure
Withheld	Supplier Qualification Plan
Withheld	Supplier Quality Systems Survey
Withheld	Label Control (DCN Controlled product)
Withheld	Batch and Lot Number Assignment Method
Withheld	Label Control (Non-DCN Controlled Product)
Withheld	Label Creation and File Control (All Product Labels)
Withheld	Label Control Form
Withheld	Pharmacy Services Label Control Form
Withheld	Work Instructions and Production History Record Requirements
Withheld	Standard Operating Procedure Requirements
Withheld	DCN Controlled Raw Materials Specification Requirements
Withheld	Product Labels and Inserts Specifications Requirements
Withheld	Equipment Preventive Maintenance System
Withheld	Component Analysis and Special process Determination Procedure
Withheld	DCN Controlled Product Specification Requirements
Withheld	Facilities, Equipment and Tooling Document Requirements
Withheld	Compounding History Record Requirements
Withheld	In-house test method procedure Requirements
Withheld	First Article procedure
Withheld	Incoming Materials Control
Withheld	Component History Form
Withheld	Quality Assurance First Article Inspection Record
Withheld	Raw Material Log Form
Withheld	Control and Calibration System For Inspection, Measurements and test Equipment
Withheld	Calibration Record Form
Withheld	Calibration Control Number Assignment Form
Withheld	Calibration/Maintenance Corrective Action Notification Form
Withheld	Inspection and Test Status
Withheld	Scrap Disposition Procedure
Withheld	Control of Non-Conforming Product
Withheld	Corrective and Preventive Action
Withheld	Product Notification and Recall
Withheld	Return Goods and Complaint Handling Procedure
Withheld	Product Misuse, Diversion or Other Anomaly Investigation Procedure
Withheld	Medication Error Procedure
Withheld	Service Complaint Form
Withheld	Return Goods Authorization Form
Withheld	Corrective and Preventive Action Request Form
Withheld	Product Misuse, Diversion and Other Anomaly Investigation Form
Withheld	Medication Error Form
Withheld	Product Complaint Form
Withheld	Inventory Control of Finished Goods
Withheld	Release and Distribution From Finished Goods
Withheld	Storage of Final Compounded Parenteral Products
Withheld	Production And Compounding History Record Control System
Withheld	Master Formulation and Control File Procedure
Withheld	Quality Records Maintenance Procedure
Withheld	Master Formulation File Approval Sheet and Revision History
Withheld	Quality Audits
Withheld	Training
Withheld	Statistical Methods
Withheld	Sampling Plans
Withheld	Order Processing Procedure
Withheld	Order Processing Procedure for Manufactured Goods
Withheld	"Pharmacy Prescription" Form (non-DCN Controlled Product)
Withheld	"Request for Compounded Medications" (Completed by physician)
Withheld	"Request for Compounded Medications" (Completed by McGuff CPS employee)
Withheld	Lot Number Assignment Form
Withheld	Batch Number Assignment Form
Withheld	Requirements for Test, Qualification and Validation Protocols and Reports
Withheld	Equipment Preventive Maintenance
Withheld	Protocol and Report Approval Sheet
Withheld	Withheld, USP
Withheld	Vial 20 mL, Serum, Glass, Clear
Withheld	Aluminum Flip-Top Regular Seals, 20mm
Withheld	Withheld, 10% (w/v), NF
Withheld	Sodium Hydroxide, 10% (w/v)
Withheld	Nitrogen, NF
Withheld	Vial 100 mL, Serum, Glass, Clear
Withheld	Sodium Hydroxide, Pellets, NF
Withheld	Withheld, 37% (w/w), NF
Withheld	Sodium Acetate, Anhydrous USP
Withheld	Sodium Chloride Powder, USP
Withheld	Acetic Acid, Glacial, USP
Withheld	Methyl Paraben, USP/NF
Withheld	Propyl Paraben, NF
Withheld	Withheld, USP
Withheld	Pantothenyl-L Alcohol FCC/USP
Withheld	Benzyl Alcohol, NF
Withheld	Vial 2 mL, Serum, Glass, Clear
Withheld	Vial 10 mL, Serum, Glass, Clear
Withheld	Vial 50 mL, Serum, Glass, Clear
Withheld	Vial 2 mL, Serum, Glass, Amber
Withheld	Vial 5 mL, Serum, Glass, Amber
Withheld	Vial 10 mL, Serum, Glass, Amber
Withheld	Withheld, Powder, USP
Withheld	Sterile Water For Injection (SWFI), USP
Withheld	Vial 30 mL, Serum, Glass, Clear
Withheld	Vial 30 mL, Serum, Glass, Amber
Withheld	Vial 50 mL, Serum, Glass, Amber
Withheld	Vial 100 mL, Serum, Glass, Amber
Withheld	Vial 5 mL, Serum, Glass, Clear
Withheld	Printer Ribbon, Resin 1.57 Inch Width
Withheld	Withheld, USP
Withheld	Vial, 20 mL, Serum, Glass, Amber
Withheld	Stopper, Siliconized, Gray Butyl, 20mm, Non-Zinc Cured (formulation 4432-50)
Withheld	Destruction of Scrap Material
Withheld	Material Review Board Procedure
Withheld	Material Review Report, Form
Withheld	Product Recall Procedure
Withheld	Returned Goods Procedure
Withheld	Audit Report And Corrective Action Follow-up Form
Withheld	Training Acknowledgment Form
Withheld	Final Labeling and Packaging Operation
Withheld	Deionized Water
Withheld	Water For Injection (WFI)
Withheld	Withheld (40% w/v)
Withheld	Facility Cleaning, Sanitation and Pest Control
Withheld	Scrubbing and Gowning Procedures
Withheld	Requirements for Working in Clean Room Environments
Withheld	Cleaning Process for Equipment and Containers Entering Product Compounding and Filling Areas of the Clean Room
Withheld	Aseptic Fill Operations, Manual Method
Withheld	Microbial Monitoring of Controlled Environment Areas
Withheld	Deionized Water System Sanitization Procedure
Withheld	Prepare Sodium Hydroxide Solution (40% w/v)
Withheld	Universal Precautions and Infection Control Procedure
Withheld	Lab Solution Preparation and Numbering Assignment
Withheld	Lab Sample Identification, Labeling and Testing (General)
Withheld	Facility Cleaning Log Forms
Withheld	Batch Record for Sodium Hydroxide Solution (40% w/v)
Withheld	Lab Solution Preparation Form
Withheld	Deionized Water System Sanitization Log Form
Withheld	Washer Batch Record Form
Withheld	Tachometer
Withheld	Weights, Balances and Scales
Withheld	Autoclave, Use and Maintenance
Withheld	Facility Requirements
Withheld	Thermometers
Withheld	Repeater Pumps
Withheld	Boiler Use and Maintenance
Withheld	Crimping Tools and Equipment, Manual
Withheld	pH Meters
Withheld	Hydrometers
Withheld	Water Purification Equipment, Deionization System Use and Maintenance
Withheld	Air Compressor (Ingersoll-Rand model # OL5), Use and Maintenance
Withheld	Labeljet Machine
Withheld	Calipers
Withheld	Clocks and Timers
Withheld	Pressure Gages
Withheld	Resistivity/Conductivity Meters
Withheld	Anemometers
Withheld	Filtration Circuit Assemblies
Withheld	RCS Air Sampler
Withheld	Carbon Dioxide Recorder
Withheld	Data Acquisition Systems
Withheld	Light Meter
Withheld	Heatblocks
Withheld	Batch Mixer, Electric
Withheld	Heating Jacket, Electric
Withheld	pH Test and Monitoring
Withheld	Final Inspection Procedure
Withheld	Foreign Matter (Particulate) and Final Container Inspection Procedure
Withheld	Test Method, Specific Gravity
Withheld	Identification of Withheld, USP
Withheld	Test Method, Bubble Point
Withheld	Test Method, Water Conductivity
Withheld	Test Method, Microbial Monitoring (Surfaces, Air and Liquids)
Withheld	Test Method, Bacterial Endotoxins via the Limulus Amebocyte Lysate (LAL) Test
Withheld	Test Method, Sterility Test
Withheld	Test Method: Label Printability Test
Withheld	Qualification Method, Technician Qualification for Aseptic Transfers/Fill Procedures
Withheld	Test Method, Density via Volumetric Weight
Withheld	Identification of Sodium
Withheld	Identification of Withheld, USP
Withheld	Identification of Withheld
Withheld	Bubble Point Test Record
Withheld	Deionization Water System Log
Withheld	Air Compressor System Log
Withheld	Facility Monitoring Log
Withheld	Foreign Matter (Particulate) and Final Container Inspection Record
Withheld	Limulus Amebocyte Lysate (LAL) Test Report
Withheld	Product-Specific LAL Test Method Validation Report
Withheld	Microbial Monitoring Report for Surface Samples
Withheld	Microbial Monitoring Report for Air Samples
Withheld	Microbial Monitoring Report for Personnel Gear
Withheld	Technician Qualification and Lysate Verification Report
Withheld	Sterility Test Report for Pharmaceutical Articles
Withheld	Microbial Monitoring of Pharmaceutical Articles (Bioburden Test, Microbial Limit Test)
Withheld	WFI Water and Steam System Log
Withheld	Lab Sample Test Form
Withheld	Boiler (Domestic Steam) Monitoring and Maintenance Log
Withheld	Label, Blank, High Gloss/S450 (3.5" x 1.25")
Withheld	Label, Blank, High Gloss/S450 (3" x 1.125")
Withheld	Label, Blank, High Gloss/S450 (2.75" x 1.0625")
Withheld	Label, Blank, High Gloss/S450 (1.75" x 0.75")
Withheld	Label, Blank, White Polypropylene (3.5" x 1.25")
Withheld	Label, Blank, White Polypropylene (3" x 1.125")
Withheld	Label, Blank, White Polypropylene (2.75" x 1.0625")
Withheld	Label, Blank, White Polypropylene (2.0" x 4.0")
Withheld	Label, Blank, White Polypropylene (3.0" x 0.51")
Withheld	Label, Blank, White Polypropylene (2.0" x 0.75")

*As you may have noticed, the McGuff Compounding Pharmacy does not display a list of specific medications that we have compounded on this web site. This is due to the regulatory environment related to compounding. The 1997 FDA Modernization Act (Modernization Act) specifically took away the right of any compounding pharmacy to advertise specific products. On April 29, 2002 the U.S. Supreme Court overturned the compounding section of the Modernization Act and we are currently allowed to advertise specific products. So why don't we?

The Supreme Court affirmed the right for our freedom of speech in a commercial environment. We agree that we should have this right. However, we also understand the reasons why the FDA did not want pharmacies to advertise compounded products. So while we are technically able to advertise products we choose not to. A big difference.

While the Modernization Act is not current law, we believe several portions of this act were good for compounding and we choose to abide with these sections even though we do not have to. As an example, the Modernization Act allowed the FDA to create a list of drugs that should not be compounded. You have our assurance we will not produce any drug that was on the FDA's list not to compound.

McGuff Compounding Pharmacy Services, Inc. • 2921 West MacArthur Blvd., Suite 142 • Santa Ana, CA 92704 •
Telephone: 877 444-1133 • Fax: 877 444-1155 •
Info: pharmacyanswers@mcguff.com

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