usp pharmaceutical compounding · pdf fileappears in a peer-reviewed article that contains:...

USP <795>

PHARMACEUTICAL

COMPOUNDING-NONSTERILE

PREPARATIONS

<795> JUNE 16, 2015- ROCKVILLE, MARYLAND

AGENDA INTRODUCTION

USP <795> REVIEW

MAJOR SECTIONS OF USP <795>

WHAT YOU SHOULD-AND SHOULD NOT -SEE

Q&A


PRE-READING USP <795> Pharmaceutical Compounding- Nonsterile Preparations

Other USP Chapters related to compounding

State regulations concerning compounding

USP <795> is a minimum standard-not a guideline


INTRODUCTION


GENERAL CHAPTERS OVERVIEW General chapters can be: Enforceable Number below <1000> Informational Number above <1000> Specific for dietary supplements Number above <2000>

Terminology “Shall” requirements

“Should” recommendations


WHO COMPOUNDS NONSTERILE PREPARATIONS? USP <795> defines compounder as a professional authorized by the appropriate jurisdiction to perform compounding pursuant to a prescription or medication order by a licensed prescriber. Pharmacists Pharmacy Technicians Physicians Veterinarians Veterinary Technicians Nurses


STATE BOARD PHARMACY JURISDICTION Community Pharmacies

Hospitals

Prescriber offices

Ambulatory Care Units

Infusion Suites

Home-Setting

Other locations

Does the Board of Pharmacy have jurisdiction over all areas?


STATUS OF GENERAL CHAPTER <795> First published in USP24-NF19 (2000)

Revision from <1161> Pharmacy Compounding Practices

Revised in USP 27-NF22 (2004)

Revised in USP 24-NF29 (2011) Incorporated <1075> Good Compounding Practices

Offcial May 1, 2011

Revision Bulletin posted November 22, 2013 Officila January 1, 2014

http:www.usp.org/usp-nf/official-text/revision-bulletins/pharmaceutical-compounding-nonsterile-preparations


SECTIONS USP <795> Introduction

Definitions

Categories of compounding

Responsibilities of the Compounder

Compounding Processes

Compounding Facilities

Compounding Equipment

Component Selection, Handling and Storage


SECTIONS USP <795> Stability Criteria and Beyond-Use Dating

Packaging and Drug Preparations Containers

Compounding Documentation

Quality Control

Patient Counseling

Training

Compounding for Animal Patients


MAJOR ELEMENTS OF THE CHAPTER

COMPOUNDING CATEGORIES PERSONNEL FACILITIES COMPONENTS

STABILITY CRITERIA DOCUMENTATION QUALITY

CONTROL/ASSURANCE ANIMAL PATIENTS


CATEGORIES OF

COMPOUNDING


CATEGORIES OF COMPOUNDING

2016. The United States Pharmacopeia Convention Inc.

SIMPLE

MODERATE

COMPLEX


CRITERIA OF CATEGORIES OF COMPOUNDING

Degrees of difficulty

Stability information warning

Package and storage requirements

Dosage forms

Complexity of calculations

Local versus systemic biological disposition

Level of risk to the computer

Potential for risk of harm to the patient


SIMPLE COMPOUNDING

Reconstitution or manipulating a commercial product that may require the addition of one or more ingredients a s directed by the manufacturer

A preparation that has a USP compounding monograph or appears in a peer-reviewed article that contains:

Specific quantities for all components

Compounding procedures and equipment

Stability data for that formulation with beyond-use date (BUD)


USP-NF MONOGRAPHS FOR COMPOUNDED PREPARATIONS

Approximately 175 official compounded preparation monographs.

Listed online at www.usp.org.usp-healthcare-professionals/compounding/compounding-monographs/usp-nf-monographs-compounded-preparations

New monographs published

6 new monographs in USP 38-NF33 1S (Official August 1, 2015)

7 new monographs in USP 38-NF33 2S (Official December 1, 2015)

6 new monographs proposed in PF 41(2) Mar/Apr 2015

Comments due May 31, 2015


http://www.usp.org.usp-healthcare-professionals/compounding/compounding-monographs/usp-nf-monographs-compounded-preparations





















USP-NF MONOGRAPHS FOR COMPOUNDED PREPARATIONS

http://www.usp.org/usp-healthcare-professionals/compounding/compounded-preparation-monographs


COMPONENTS OF A COMPOUNDED PREPARATION MONOGRAPH Title

Definition Lists the range of labeled amount of active ingredient

Formula Ingredients and quantities

Compounding procedures

Stability-indicating Assay

pH

Packaging and Storage

Labeling

Beyond-use dates Stability studies

Chapters n<795> or <795>


MODERATE COMPOUNDING

Making a preparation that requires special calculations or procedures to determine quantities of components per preparation or per individualized dosage units.

Making a preparation for which stability data for that specific formulation is not available

Example: mixing two or more manufactured creams when the stability of the mixture is not known


COMPLEX COMPOUNDING

Making a preparation that requires special training, environment, facilities, equipment, and procedures.

Example:

Transdermal dosage forms

Modified-release preparations


RESPONSABILITIES OF THE

COMPOUNDER


RESPOSIBILITES OF THE COMPOUNDER

Compounder must be proficient in compounding

The compounder must prepare compounds With acceptable strength, quality and purity

In accordance with prescription or medication order

Finished preparation with appropriate packaging and labeling

In compliance with established state agencies, state boards of pharmacy, federal law, and other regulatory agencies.


OTHER <LOCATIONS> <LOCATION> TITLE

General Notices

17 Prescription Container Labeling

659 Packaging and Storage Requirements

797 Pharmaceutical Compounding- Sterile Preparations

1066 Physical Environments that Promote Safe Medication Use

1151 Pharmaceutical Dosage Forms

1160 Pharmaceutical Calculations in Prescriptions Compounding

1163 Quality Assurance in Pharmaceutical Compounding

1178 Prescription Balance and Volumetric Apparatus

1191 Stability Considerations in Dispensing Practice

1265 Written Prescription Drug Information-Guidelines


GENERAL PRINCIPLES OF COMPOUNDING

Training and documentation of competence

Compounding ingredients

Equipment

Facilities

Quality control and assurance

Error prevention

Documentation


SHALL STATEMENTS: RESPOSIBILITIES OF A COMPOUNDER

Compounder SHALL acquire and maintain knowledge and skills for which they compound.

Compounders SHALL adhere to general principles listed <795>

Individuals who are engaged in drug or dietary supplement compounding SHALL be proficient.


BUSINESS MODEL FOR COMPOUNDING

There must be responsibility to meet standards

Ethical responsibility Helps achieve safety and efficacy

Key Components Personnel

Facilities

Components

Quality Control and Assurance


COMPOUNDING

WHAT IS COMPOUNDED? WHAT SHOULD NOT BE COMPOUNDED?

IF IT MEETS PATIENTS NEEDS IT IS EVIDENCE-BASED IT IS APPROPIATE

INGREDIENTS THAT DO NOT MEET IDENTIFICATION, QUALITY AND PURIFTY SPECIFICATIONS.

HUMAN USE: IF ITS PART OF THE DO NOT COMPOUND FDA LIST.

ANIMAL FOOD USE: IF ITS PART OT THE FDA NOT COMPONENTS LIST


PERSONNEL TRAINING


ORIENTATION AND TRAINING USP M<795>

Other applicable USP Chapters

Safety Data Sheets (SDS, formerly MSDS)

Hazardous drug safety

Facility policies and procedures

Oversight by skilled compounder

Demonstration of verbal and functional knowledge

Review and approval by compiounded supervisor

Documentation of competence

Annual review of skills


COMPETENCY DOCUMENTATION


POLICIES AND PROCEDURES

Policies and procedures must be available to staff

Evidence of review

It must reflect current practice and regulatory requirements


PERSONNEL TRAINING SHALLS

Personnel SHALL be properly trained

All training activities SHALL be documented

Employees involved in pharmaceutical compounding SHALL read and become familiar with <795>

Employees SHALL read and become familiar with each of the procedures related to compounding

The compounder SHALL meet with employees [being trained] to review their work and answer any question the employees may have concerning compounding procedures.


PERSONNEL TRAINING SHALLS

Personnel SHALL demonstrate the procedures for the employee.

Personnel SHALL observe and guide the employee throughout the training process

The compounder should be physically present and SHALL approve all ingredients an their quantities ant he final preparation.

The compounder SHALL constantly monitor the work of the employee and ensure that the employee’s calculations and work are accurate and adequately performed.


COMPONENT SELECTION

HANDLING AND

STORAGE


DEFINITIONS

API: Active Pharmaceutical Ingredient

The active ingredient

Added Substance

Inactive ingredients, excipients, pharmaceutical ingredients

Vehicle

Carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended


CERTIFICATE OF ANALYSIS


DIETARY AND NUTRITIONAL SUPPLEMENTS

Must comply with any federal or state regulations

Generally, dietary supplements are prepared from ingredients that meet USP, NF, or FCC standards.

If not, it must have acceptable food-grade quality


EXPIRATION DATE OF BULK COMPONENTS

If there is no expiration date Label with the date of the receipt

Assign a conservative expiration ate

Cannot exceed three years from date of receipt

DO NOT USE AFTER

3 YEARS

BULK API


WHEN MANUFACTURED DRUG PRODUCT IS USED

Must be manufactured in an FDA-registered facility

Label with batch control number and expiration date

Compounder must consider all ingredients (e.g., excipients) in the manufactured product on the therapeutic appropriateness and stability.

Retrieved fron: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjLt_ad15rVAhVGRSYKHVFwCGcQjRwIBw&url=http%3A%2F%2Fwww.pharmavize.com%2Fservices%2Fdrug-product-manufacturing&psig=AFQjCNERpVpJCbpFInLpPpxSdW84GgloFA&ust=1500736947960653


WATER

Potable water (hand washing & equipment washing)

Purified water Is a SHALL requirement for

compounding Is a SHOULD requirement for rinsing

equipment and supplies Methods of purification include:

deonization, distillation, ion exchange, reverse osmosis, filtration, etc.

Retrived fron: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwikoKaX2JrVAhWBLSYKHek6AQ8QjRwIBw&url=http%3A%2F%2Fall-about-water-filters.com%2Fproducing-distilled-water-in-the-laboratory%2F&psig=AFQjCNHV0p_urpuuUtldx6Bwpfm6hCd5Cg&ust=1500737274204564


STORAGE Must be stored as directed by the manufacturer or according to USP, NF or FCC monograph requirements

Appropriate temperature and humidity

Labeled appropriately

Off the floor

Handled and stored to prevent contamination.

Rotated so that oldest stock is used first.

Retrived fron: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiv0-Xv2JrVAhXH5CYKHY-cAToQjRwIBw&url=http%3A%2F%2Fwww.staffordpharmacy.com%2Fpharmacy%2Fcompounding%2Four-compounding-lab-a-brief-virtual-tour%2F&psig=AFQjCNESiaVGwXbP4plJJVZ6TJObTbrW6w&ust=1500737468018533


STORAGE CONDITIONS (<659>)

Retrived fron: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiv0-Xv2JrVAhXH5CYKHY-cAToQjRwIBw&url=http%3A%2F%2Fwww.staffordpharmacy.com%2Fpharmacy%2Fcompounding%2Four-compounding-lab-a-brief-virtual-tour%2F&psig=AFQjCNESiaVGwXbP4plJJVZ6TJObTbrW6w&ust=1500737468018533

STORAGE TEMPERATURES

DEGREES FAHRENHEIT

DEGREES CENTIGRADE

Controlled Room Temperature

68˚ to 77˚ 20˚ to 25˚

Refrigerator 36˚ to 46˚ 2˚ to 8˚

Freezer -13˚ to 14˚ -25˚ to -˚10


SHALL STATEMENTS Guidelines (from <795>) SHALL be followed

Potable water SHALL be supplied for hand and equipment washing

Purified water SHALL be used for compounding

All components, equipment, and containers SHALL be stored off the floor and in a manner to prevent contamination and permit inspection and cleaning of the compounding and storage area


SHALL STATEMENTS Compounders SHALL first attempt to use components manufactured in FDA-registered facilities

When components cannot be obtained from an FDA-registered facility, compounders SHALL use their professional judgement in selecting an acceptable and reliable sources and SHALL establish purity and safety by reasonable means


SHALL STATEMENTS

If the component has been transferred from the original container, the different container SHALL be identified with the component name, original supplier, lot or control number, transfer date expiration date and SHALL provide integrity that is equivalent to or better that the original container.


SHALL STATEMENTS

For components without an expiration ate, the compounder SHALL label the container with the date or receipt and assign a conservative expiration date, no to exceed three years from date of receipt.

If a manufactured product is used as the source of active ingredient, the drug product SHALL be manufactured in an FDA-registered facility, and the manufacturer’s drug product SHALL be labeled with a batch control number and expiration date


SHALL STATEMENTS

When compounding with manufacture red drug products, the compounder shall consider all ingredients

When component is derived from ruminant animals, the supplier SHALL provide written assurance that the component is in compliance with all federal laws governing processing


SHALL STATEMENTS

All containers SHALL be properly labeled

Safety Data Sheets (previously known as MSDS) SHALL be readily accessible

All components SHALL be stored off the floor, handled to prevent contamination, and rotated so that the oldest stock is used first


STORAGE-HAZARDOUS DRUGS

<800> Hazardous Drugs-Handling in Healthcare Settings Proposed in PF40(3) May/Jun 2014

NIOSH information is advisory

NIOSH Hazardous Drugs Different from EPA hazardous

Separate area

Negative pressure

12 air changes per hour


SHALL STATEMENTS: HAZARDOUS DRUGS

Hazardous drugs SHALL be stored, prepared and handled by appropriately trained personnel under conditions that protet the healthcare worker and other personnel.

All personnel who perform routine custodial waste removal and cleaning activities in storage and preparation reas for hazardous drugs SHALL be trained in appropriate procedures to rpotet themselves and prevent contamination.


SHALL STATEMENTS: HAZARDOUS DRUGS

All personnel who compound hazardous drugs SHALL be trained in the storage, handling, and disposal of these drugs.

The training SHALL occur before preparing or handling hazardous drugs.

Disposal of hazardous drugs waste SHALL comply with all applicable federal and state regulations


COMPOUNDING

FACILITIES


FACILITIES

Adequate space specifically designed for compounding Separate and distinct from sterile preparation area

Clean orderly, sanitary, and in good state of repair

Orderly placement of equipment and materials

Designed, arranged, and used to prevent cross-contamination

Well-lighted

Appropiate heating, ventilation, air conditioning


FACILITIES

Hand and equipment washing facilities

Hot and cold water

Soap or detergent

Air-dryer or single-use towels

Plumbling system


STOCK

Component, container, and closure stock stored off the floor

Rotated so oldest stock is used first


WASTE

Waste held and disposed of in sanitary and timely manner

In accordance with local, state, and federal guidelines


SHALL STATEMENTS: FACILITIES

Compounding facilities SHALL have adequate space that is specifically designed for compounding of prescriptions

Area SHALL be provided for orderly placement of equipment and materials

Areas used for sterile preparations SHALL be separated and distinct from the nonsterile compounding area



The area used for compounding SHALL maintain in clean, orderly, and sanitary conditions and SHALL be maintained ina good state of repair

Plumbing system SHALL be free of defects

Adequate hand and equipment washing facilities SHALL be easily accessible to the compounding area. Such facilities SHALL include, but are not limited to, hot and cold water, soap or detergent, and air-drier or single-use towels



Heating, ventilation, and air conditioning systems SHALL be controlled to avoid decomposition and contamination of chemicals

Waste SHALL held and disposed of in a sanitary and timely manner and in accordance with local, state and federal guidelines.


COMPOUNDING

EQUIPMENT


EQUIPMENT AND UTENSILS

Appropriately designed

Adequate capacity

Surfaces that contact components are not reactive,a dditive, nor sorptive

Are maintained as directed by the manufacturer

Refer USP <1176> Prescription Balances and Volumetric Apparatus

Calibrated if necessary


SHALL STATEMENTS: EQUIPMENT

Equipment used in compounding or testing of compounding preparations SHALL be routinely inspected, calibrated as necessary, and checked to ensure proper performance

Immediately before compounding operation, the equipment SHALL be inspected by the compounder to determine its suitability for use

After use, the equipment SHALL be properly cleaned



The equipment and utensils used for compounding of a drug preparation SHALL be of appropriate design and capacity

The equipment SHALL be of suitable composition that the surfaces that contact components are neither reactive, addictive, nor sorptive

Equipment SHALL be stored to protect it from contamination and SHALL be located to facilitate its use, maintenance, and cleaning



When the same equipment is used for all drug products, appropriate procedures SHALL be in place to allow meticulous cleaning of equipment before use with other drugs.


CONTAINERS &

PACKAGING


CONTAINERS AND CLOUSERS

Suitable, clean material

Non-reactive

Cannot alter quality, strength, or purity


USP STANDARDS: CONTAINERS & PACKAGING <LOCATION> TITLE

General Notice and Requirements

Compounding Monographs

659 Packaging and Storage Requirements

660 Containers-Glass

661 Containers-Plastic

671 Performance Testing

681 Repackaging into Single-Use Containers and Unit Dose Containers for Nonsterile Solid and Liquid Dosage Forms

1136 Repackaging –Unit-of-Use


RESPONSIBILITY

The compounder SHALL ensure that the containers and container closures used in packaging compounded preprations meet USP requirements.

Compounders are not required to perform the tests listed, but need to be knowledgeable

Containers and closures SHALL be made of suitable clean materials in order no to alter the quality, strength, or purity of the compounded drug preparation.

Container suppliers SHALL supply, upon request, verification of USP compliance


SHALL STATEMENTS: CONTANERS & PACKAGING

The containers and closures SHALL be stored off the floor, handled and stored to prevent contamination, and rotated so that the oldest stock is used first

The containers and container closures SHALL be stored in such a way as to permit inspections and cleaning of the storage area


STABILITY CRITERIA

& BUDs


BEYOND USE DATES

Differs from the manufacturer’s expiration date

The date after which a compounded preparation SHALL not be used

Manufacturers USP monographs, and peer-reviewed articles may provide BUD information


BEYOND USE DATES

TRADITIONAL CURRENT

Chemical Stability of the drug

Chemical stability of the compounded preparation

Based on drug-specific & general stability documentation/literature to reduce potential of falling outside required USP str3egth (+/-

10% of labeled content)

Stability in Container

Expected Storage Conditions

Competent Personnel


STABILITY OF COMPOUNDED NONSTERILE PREPRATIONS

Manufacture’s information ◦ Package insert

USP ◦ Compounding monographs

◦ All applicable USP General Notices and Chapters

◦ Peer-Reviewed Literature


BUD BY TYPE OF FORMULATION

TYPE OF FORMULATION MAXIMUM BUD

Non-Aqueous formulation 6 months

Water-containing oral formulations 14 days under

refrigeration

Water-containing topical/derma and mucosal liquid and semisolid formulations

30 days


SHALL STATEMENTS: STABILITY CRITERIA & BUDs

The BUD is the date after which a compounded preparation SHALL not be used

The BUD SHALL not be later than expiration date on the container of any components

When determining a BUD stability factors in USP <1191> Stability Considerations in Dispensing Practices SHALL be considered ant he compounder SHALL use his or her compounding education and experience



When assigning a BUD compounders SHALL consult and apply drug-specific and general stability documentation and literature

The compounder SHALL observe the compounded dug preparation for sings of instability.


LABELING


LABELING

USP <795>

State regulations

ISMP recommendations http://www.ismp.org/tools/guideli

nes/labelformats/comments/printerVersion.pdf.

USP <17> Prescription Container Labeling

General Notices


http://www.ismp.org/tools/guidelines/labelformats/comments/printerVersion.pdf











PATIENT NOTIFICATION

The labeling should indicate that “this is a compounded preparation.



The label SHALL include in addition to legally required information, the generic name and quantity or concentration of each active ingredient, assigned BUD, storage conditions, and prescription or control number

Labeling of preparation containers SHALL include the beyond-use date and handling information.

Required Label

Elements


DOCUMENTATION


REQUIRED DOCUMENTATION

Master Formulation Record

Compounding Record

Standard Operating Procedures

Safety Data Sheets (SDSs previously MSDSs


DOCUMENTATION

Enable to systematically trace, evaluate, and replicate steps included throughout the preparation process

Record retention- as required for prescriptions under state of law


DOCUMENTATION

Written or electronic

Comply with record-keeping requirements of State Board of Pharmacy

Documentation is not required when preparing a compound according to the manufacture's labeled instructions

All other compounds require Master formulation record

Compounding record


MASTER FORMULATION RECORD

Officiall or assigned name, strength, dosage form

Calculations and doses

Ingrendients and quantities

Compatibility and stability info and references

Equipment needed

Mixing instructions

Label information

Container Used

Packaging and Storage requirements

Description of the final preparation

Quality Control procedures and expected results


COMPOUNDING RECORD

Official or assigned name, strength, dosage form

Reference to Master Formulation Record

Names and quantities of all components

Sources, lot numbers, and expiration dates of components

Total quantity compounded

Names of persons prepared, performed WC, and approved the preparation


COMPOUNDING RECORD

Date of preparation

Assigned control or prescription number

Assigned BUD

Copy of label

Description of final preparation

Results of QC (weigh of capsule, pH of liquid)

Documentation of any QC issues and any ADRs reported by patient


STANDARD OPERATING PROCEDURES

SOPs should ensure Accuracy

Quality

Safety

Uniformity in compounding

Accountability

SOPs should include Facilities of preparation

Equipment for packaging

Personnel

Storage


SAFETY DATA SHEETS

Formerly known as MSDS

Information available on OSHA website

www.osha.gov/Publications/OSHA3514.html


SHALL STATEMENTS: DOCUMENTATION

A master formulation record shall be followed

The master formulation record shall include the elements listed in USP <795>

The compounding record shall include the elements listed in USP <795>


QUALITY CONTROL


QUALITY ASSURANCE PLAN

Quality control

Personnel orientation and training

Variances

Trends


<1163> QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING

Training

SOPs

Documentation

Verification

Testing

Cleaning and Disinfection

Containers, packaging, labeling and storage

Outsourcing

Responsible Personnel


SHALL STATEMENTS: QUALITY CONTROL

The compounder SHALL have established written procedures that describe the tests of examination conducted on the compounded preparations to ensure their uniformity and integrity

Appropriate control and procedures SHALL be established to monitor the output and to verify the performance of compounding processes and equipment that may be responsible for causing variability in the final compounded preparations.



The compounder SHALL review each procedure in the compounding process

The master formulation record, the compounding record and associated written procedures SHALL be followed in execution of the compounding process

The compounder SHALL check and recheck each procedures at each stage of the process



The compounder SHALL observe the finished preparation to ensure that it appears as expected and SHALL investigate any discrepancies and take appropriate corrective action before the prescription is dispensed to the patient.

The compounder SHALL investigate and document any reported problem with a compounded preparation and SHALL take corrective action.


PATIENT

COUNSELING


SHALL STATEMENTS: PATIENTS COUNSELING

The patient or patients agent SHALL be counseled about proper use and instructed to report any adverse event.


COMPOUNDING FOR

ANIMAL PATIENTS


SHALL STATEMENTS: ANIMAL PATIENTS

The intended use of any animal patient (e.g., companion, performance, food) SHALL be determined before compounding for that patient

All compounders preparing formulations for animals SHALL possess a functional knowledge of drug regulation and disposition in animal patients


WITHDRAWL TIME (WDT)

Veterinarians are required by law to provide food-producing animal caregivers with an accurate length of time to withhold treated animal tissues (e.g. meat, milk, eggs) from the human food supply

This WDT must be included on the dispensing label of every prescription prepared for a food producing species


SHALL STATEMENTS: ANIMAL PATIENTS

If formulations specifically developed for animal patients are not available, the compounder SHALL conduct a literature rewview to determine whether a specific component of the formula is toxic to the target species

All compounders who prepare animals formulations SHALL possess a functional knowledge of drug regulation and disposition in animal patitents

The pharmacist SHALL be knowledgeable about the individual species’ limitations in physiology and metabolic capacity that can result in toxicity when certain drugs or excipients are used in compounded preparations


WHAT YO SHOULD

AND SHOULD NOT SEE:

WORK PRACTICES


COMPLIANCE WITH USP <795>

USP <795>

State Regulations State Board of Pharmacy

State Department of Health

Other?

Accreditation organizations


LICENSE, PERMITS, REGISTRATION

Current

All applicable documentation

Accreditation organizations often require primary source verification


FACILITIES Area dedicated to compounding

Separation of hazardous drugs

Separation of sterile preparations Compliance with USP <797>

Neat, clean and uncluttered

Plumbing

Sink

Waste Removal


COMPONENTS Storage

Items that meet USP, NF, or FCC standards Products from FDA-registered facilities

Expiration dates on all components

Purified Water for compounding and rinsing equipment


SPECIAL FACILITIES Nuclear pharmacies <823> Position Emission Tomography Drugs for Compounding,

Investigational, and Research Uses

Pharmacies that compound for investigational studies <1168> Compounding for Investigational Studies

Previously proposed in PF39(5) Sept/Oct2013

Official publication date to be determined


RED FLAGS Manufacturing-scale equipment

Dosage forms that are difficult to make

Drugs withdrawn from the market due to safety reasons

Copies of commercially-available products

Use of components without USP, NF or FCC standards or use of products from non-FDA-registered facilities

Sterile preparations (e.g., ophtalmics) without separate area compliant with <797>


PERSONNEL

Selection Suitability

Training

State and facility requirements for certifications


HAND HYGIENE

Hand Hygiene Policy

Practice


GARB Intent: protect personnel from chemical exposure and prevention of drug contamination

Clean clothing appropriate for the type of compounding performed

Hair bonnets

Coats

Gowns

Gloves

Face masks

Shoes

Aprons


DOCUMENTATION Master formulation records

Compounding records

Policies and procedures (SOPs)

Safety Data Sheets


FINISHED PREPARATIONS Checking process

Appropriate label

Appropriate BUD

Packaging


usp pharmaceutical compounding · pdf fileappears in a peer-reviewed article that contains:...

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