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USP <797> and <800>Changes in USP-NF Compounding Guidelines

Upcoming Changes to USP <797> and Implementation of USP <800>

Jered Pasay, MS

Laboratory Scientist Surveyor, Maryland Board of Pharmacy

DisclaimerI speak for myself and do not intend to represent the thoughts or opinions of any others. Any opinions expressed in this presentation or on the following slides are solely those of the presenter and not those of the State of Maryland, its elected officials, or employees.

The information provided herein is general information and should not be construed as legal advice of the Maryland State Board of Pharmacy, the State of Maryland, or any official agency, or employee thereof. Furthermore, the information on these slide may not necessarily reflect the most current legal developments.

Goals of this Presentation

1. To be able to identify some of the significant changes affecting sterile compounding practices in the proposed USP <797>

2. Describe the basic requirements of USP <800>

3. Identify the potential effects of USP <800> on pharmacy practices

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Overview1. Introduction and Background

2. Proposed changes to USP <797>

3. Hazardous Drug Regulatory History

4. USP <800> Requirements

5. Hazardous Drug Considerations

6. Summary

7. Questions

8. Resources

What is USP?

Ø United States Pharmacopeia-National Formulary (USP)

Ø Formed in 1840 to standardize drugs and create the National Formulary.

Ø USP is a non-profit organization recognized worldwide as an organization that sets standards for OTC and prescription drugs for both human and animal use.

Ø USP is not a federal agency and does not set laws or regulations, however, USP standards are adopted by both federal and state governments and adopted as law.

USP Standards for Pharmacy Compounding and Hazardous Drug Handling

Ø USP 795 Guidance for Non-Sterile Compounding

Ø USP 797 Guidance for Sterile Compounding

Ø USP 800 Hazardous Drug Handling in Healthcare settings

Shall, Must or Should?

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http://www.usp.org/compounding/updates-on-standards

USP <795> and <797> Revision Timeline

USP 797 Pharmaceutical Compounding: Sterile Preparations

Ø Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication.

Ø The purpose of USP 797 is to describe the minimum standards to be followed when preparing compounded sterile human and animal drugs based on current scientific information and best practices for sterile compounding.

Ø The chapter describes conditions and practices that prevent harm, including death, to patients that could result from compounded sterile preparations due to microbial contamination, excessive bacterial endotoxins, variability in intended strength of the product, unintended chemical and physical contaminants, or ingredients of inappropriate quality.

Proposed Changes to USP <797>Ø To separate out specialty drug handling as separate chapters (800 & 825).

Ø To better organize the chapter, better clarify material, and create references to other chapters.

Ø To update minimum standards to more current practices.

Ø Revisions took more than 8000 comments from more than 2500 stakeholders into consideration when making revisions.

Ø Proposed revisions available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf

Ø USP Web Recording and Presentation on revisions available at: http://www.usp.org/compounding/updates-on-standards

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Drug ClassificationsØ No longer Low, Medium, and High risk classifications based on starting materials and

compounding method.

Ø Classifications are primarily based on the conditions under which compounded sterile preparations (“CSPs”) are made, the probability for microbial growth, and the time period within which they must be used.

Category 1

§ Primary Engineering Control (“PEC”)• LAFS, RABS, Isolator

§ Unclassified Segregated Compounding Area§ ≤ 12 hours Room temp (20°- 25°)§ ≤ 24 hours Refrigerated

Category 2

§ Primary Engineering Control (“PEC”)• LAFS, RABS, Isolator

§ ISO 7 Buffer Room with ISO 8 Ante-Room§ Long term storage up to 90 Days

By Use Dates (BUDS) Category 2 CSPsPreparation Characteristics Storage Conditions

Sterilization Method

Sterility Testing Performed

Room Temp(20° - 25°)

Refrigerator(2° - 8°)

Freezer(-25° to -10°)

Aseptically Prepared

No1 Day* 4 Days* 45 Days*

4 Days‡ 9 Days‡ 45 Days‡

Yes 30 Days 45 Days 60 Days

Terminally Sterilized

No 14 Days 28 Days 45 Days

Yes 45 Days 60 Days 90 Days

* CSPs prepared from one or more nonsterile starting component(s) ‡ CSPs prepared from only sterile starting components.

Using CSPs as ComponentsØ Single-Dose Containers§ Entered or punctured in ISO 5 or cleaner air. § Discard within 6 hours from initial entry or puncture.

Ø Stock Solutions§ Entered or punctured in ISO 5 or cleaner air.§ Discard within 6 hours from initial entry or puncture.§ Stored in accordance to assigned BUD.

Ø Multiple-Dose Containers§ Must not be used for longer than assigned BUD or 28 days if supported by antimicrobial

effectiveness testing results, whichever is shorter.

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End Product TestingØ Visually Inspection§ Required for all CSPs.§ Looking for particulates, discoloration, closure integrity, the label matches the prepared

medication, etc.

§ If a CSP is stored before release it must inspect for precipitation, cloudiness, leakage, etc.

Ø Sterility Testing – performed according to USP <71>§ Only performed on Category 2 CSPs if assigned a longer BUD.

§ If <40 CSPs are prepared an additional 10% rounded up must be prepared for use in testing.

Ø Endotoxin Testing – performed according to USP <85>§ Not required for inhalation or topical ophthalmic preparations.§ Only performed on Category 2 CSPs made from ≥ 1 nonsterile ingredients and assigned a longer

BUD.

Secondary Engineering Controls (SEC) Requirements

Ø Temperature and humidity must be monitored daily.

§ Should be 20°C or cooler with a relative humidity below 60%.

§ Must be controlled by the HVAC system.

Ø HVAC returns must be low on the wall unless a visual smoke study demonstrates dilution

of particles and sweeping out of particles from the entire room.

§ Repeated whenever a PEC is moved, or equipment (shelving) introduced to room.

Ø The ante-room must have a line-of-demarcation segregating the clean from the dirty side

of the room.

Ø Air changes per hour (“ACPH”) must be maintained under dynamic operating conditions.

Ø All surfaces must be smooth, impervious, free from cracks and crevices, and non-shedding.

Environmental TestingØ Written procedures for air and surface monitoring must be developed and

implemented.§ Results from air and surface sampling must be reviewed in conjunction with personnel assessment

data to assess the state of control and to identify potential risks of contamination.

§ Data must also be reviewed following corrective actions to confirm the effectiveness of actions taken.

Ø Air and surface monitoring must be conducted during dynamic operating conditions.

Ø Surface sampling must be conducted monthly.

Ø If microbiological growth exceeds action limits the microorganisms must be identified to the genus level.

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Testing Locations and Action LimitsACTION LIMITS

ISO Class Air (CFU/sample) Surface (CFU/sample)

5 >1 >3

7 >10 >5

8 >100 >50

TESTING LOCATIONSAir Surface

All ISO Classified Areas

The interior of the PEC and the equipment within

Staging or work area(s) near the PEC

Frequently touched surfaces

Pass-through chamber(s)

Hand Hygiene and GarbingØ Brushes must not be used for hand hygiene.

Ø Hand driers must not be used.

Ø Soap must not be added to a partially-empty soap dispenser.

Ø Ear Buds, Headphones, and electronic devices not necessary for compounding are not allowed into the compounding area.

Ø If compounding on a restricted-access barrier system (RABS) (CAI or CACI), disposable gloves are to be worn inside the gauntlet gloves and sterile gloves place over the gauntlet gloves.

§ Gloves on hands and gauntlet sleeves on RABS and Isolators must be routinely inspected for damage and replaced immediately if defects are found.

Cleaning and DisinfectingØ Surfaces must be cleaned prior to being disinfected unless an EPA registered one-step disinfectant

cleaner is used.

Ø All cleaning and disinfecting activities must be performed by trained and appropriately garbed personnel using facility-approved agents and procedures, which must be described in written SOPs

Ø Sporicidal agents, shown to be effective against the species Bacillus, must be used at least monthly to disinfect all surfaces in classified and SCAs

Ø Reusable cleaning tools must be dedicated for use in the classified areas or SCA and must not be removed from these areas except for disposal

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Personnel Evaluation and RetrainingVisual observation: Compounding personnel must be visually observed while performing hand hygiene and garbing procedures initially, and then at least every 6 months.

Gloved fingertip sampling and Media-fill testing: at least every 6 months.

Cleaning and disinfecting: Retrain and requalify personnel in cleaning and disinfecting compounding areas in conjunction with any change(s) in cleaning and disinfecting procedures.

After a pause in compounding: If personnel have not compounded CSPs in more than 6 months they must be requalified in all aspects of sterile compounding.

Reorganization of USP <797>Ø All references to compounding of hazardous drugs removed from the chapter and

transferred to chapter 800 “Hazardous Drugs—Handling in Healthcare Settings”.

Ø All references to compounding of radiopharmaceuticals removed from the chapter and transferred to chapter 825 “Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging”.

NOTE: Sterile compounding of hazardous drugs and/or radiopharmaceuticals must comply with 797, their respective chapter, state and federal guidelines.

From a Compendial standpoint any chapter under <1000> is enforceable through reference in the General Notices, a Monograph, or another applicable general chapter below <1000>.

Kalanchoe Break

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USP <800>HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS

Practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.

In Brief USP <800> Requires:

Ø A list of HDs on premisesØ Primary and secondary engineering controlsØ Competent personnelØ Safe work practicesØ Proper use of appropriate personal protective equipment (PPE)Ø Policies for HD waste segregation and disposal

HD Regulatory History1960s – Risks of HDs first start showing up in scientific literature

1970s – Europe finds HD drug residues in Nurses’ urine and start health evaluations

1980s – First bulletin on HDs is published

2004 – NIOSH published an alert of exposure to HDs

2010 – Development of USP <800> started– Based on materials from OSHA, EPA, the NIOSH Alert, the NIOSH list, ASHP, ONS, the Joint Commission, and others

2016 – USP <800> Final draft is published2018 – Implementation delayed to coincide with release of revised USP <797>

December 1, 2019, USP <800> Scheduled to go into Effect

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NIOSH ListØ Published by the Centers for Disease Control and Prevention(CDC): National Institute of

Occupational Safety and Health.

Ø A compiled list of HD including: Cancer chemotherapy, antivirals, hormones, some bioengineered drugs, and other miscellaneous drugs which can cause harm due to exposure.

Ø Carcinogenic, Teratogenic, Genotoxic, Reproductively Toxic, Organ Toxicity at low levels and/or the structure and toxicity profile mimic a drug already on the list.

Ø Great resource on the safe-handling of HDs.

NIOSH Drug Categories

Group 1

Antineoplastic Drugs

Group 2

Non-antineoplastic drugs that meet one or more NIOSH criteria

as hazardous

Group 3

Non-antineoplastic drugs that primarily have reproductive

effects

Types of ExposureØ DermalØ Mucosal Absorption Ø InhalationØ IngestionØ Injection

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Where/when can you be Exposed? Ø ReceiptØ StorageØ CompoundingØ DispensingØ AdministrationØ DisposalØ Cleanup

Managing ExposureMost

Effective

LeastEffective

• Remove

• Replace

• Isolate

• Change Work Practices

• Personal Protective Equipment (PPE)

Designated ExpertØ Implement appropriate operating procedures.

Ø Oversee regulatory compliance.

Ø Ensure proper training.

Ø Ensure proper environmental controls.

Ø Maintain reports and documentation.

Ø Perform Corrective Action Preventive Action (CAPA) for any HD related incident.

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HD List and Risk Assessment1. Read NIOSH List and determine which drugs are in inventory or regularly

dispensed/used.

2. Determine risk of HDs in inventory and dosage forms.

3. Determine your approach for handling HDs:

4. Review annually.

**Antineoplastics for manipulation and any Bulk HD APImust follow USP <800>**

Treat all HDs the same and follow USP <800>

Perform assessment of risks of HD’s to determine level of compliance

TrainingØ All personnel in a facility that handle HDs must be trained in safe handling.

Ø Training is to occur at least every 12 months.

To Include:

• Review of HD handling policies• Review of all drugs on premises• Exposure protocols• Proper use of PPE

• Proper use of equipment• Spill Management• Disposal of HDs and contaminated

items

PPE (Personal Protective Equipment)Appropriate PPE must be worn at any time you are handling HDs

Ø Gloves – Chemotherapy rated (American Society for Testing and Materials (ASTM) standard D6978)§ Powder Free.§ Compounding – 2 pairs of gloves, outer pair are chemotherapy gloves, sterile compounding requires sterile outer gloves.§ Changed every 30 minutes or when damaged or contaminated.

Ø Gowns – Resist permeability, close in back, long sleeved, no seams, and closed cuffs.§ Must be changed per manufacturer’s information or every 2-3 hours or after a spill or splash.§ Gowns worn in HD handling areas must be removed prior to entering non HD areas.

Ø Shoe Covers – worn in HD handling areas must be removed prior to entering non HD areas.§ Sterile Compounding – 2 pairs of shoe covers.

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PPE (Personal Protective Equipment) pt. 2Ø Head, Hair, Beard Covers – Required during the compounding of HDs.

Ø Eye Protection – Goggles§ Must be worn when there is a risk for spills or splashes when working outside of a hood.

Ø Respiratory Protection – Half-mask with P100-filter or an N95 NIOSH-certified Respirator.§ Appropriate full-facepiece, chemical cartridge-type respirator or powered air-purifying respirator (PAPR)

should be worn when there is a risk of respiratory exposure to HDs, including when:

o Attending to HD spills larger than what can be contained with a spill kit.o Deactivating, decontaminating, and cleaning underneath the work surface of a C-PEC.o There is a known or suspected airborne exposure to powders or vapors.

PPE worn while handling HDs should be considered contaminated and must be disposed of appropriately.

Cleaning, Deactivation & DecontaminationAll areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned.

§ Sterile areas must be subsequently disinfected

Agents should be applied through wiping as spraying may spread HDs.1. Deactivation – rendering the compound inert or inactive.

§ No “magic bullet”, you must research your HDs to see what agents will work.§ Common agents: peroxide formulations, sodium hypochlorite

2. Decontamination – removing HD residue.§ Common agents: alcohol, water, peroxide, sodium hypochlorite

3. Cleaning – removing organic and inorganic materials.§ Detergent or germicidal detergent for sterile compounding

Hazardous Communication (HAZCOM)Required of a locations that work with HDs.

Ø How standards will be implemented.

Ø HDs must be appropriately labeled.

Ø Personnel of reproductive capability must confirm in writing their understanding of the risks of working with HDs.

Ø Personnel must be provided information and training:§ Prior to initial assignment of HD work§ Whenever HDs or HD related procedures change

Ø A Safety Data Sheet (SDS) for each HD must be readily accessible to all staff.

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Environmental MonitoringRecommended to test prior to HD processing and then every 6 months.Ø To confirm adequate deactivation and decontamination of HDs.

Ø To confirm adequate segregation controls (PPE and facility controls).

Ø As a follow-up to a spill.

Testing is not mandatory only because certifying agencies do not exist for these kits, and contamination levels have not validated.

Medical Surveillance PlanRecommended periodic testing, exit examination, and follow-up plans for all staff handling HDs.

Ø Blood and or Urine testsØ Physical findings of an exam

Ø Symptom complaints

To minimize adverse health effects and allows for trending of data for early detection of issues.

Any testing needs to protect private information and be compliant with HIPPA.

Post exposure testing:Ø Tailor for the HD type and type of exposureØ Ensure two way communication with staff member

Ø Develop a CAPA to prevent future exposureØ Provide follow-up medical surveillance

Spill KitØ Required to be readily available wherever HDs are routinely handled.Ø Personnel must be trained on cleanup and available whenever HDs are being handled.Ø Spills are to be contained and cleaned immediately.

Ø Kits must contain all materials needed to clean HD spills including: § PPE§ Towels§ waste containers§ cleaning agents § signs to restrict access to the spill area

Ø All spill materials are considered hazardous waste.Ø Spill event and cleanup must be documented.

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Receiving HDsØ Open shipping containers in a segregated negative or neutral pressure room.

Ø Inspect for damage or leakage and unpack containers.

Ø Recognize HDs and separate to transport to HD storage area.

Ø PPE- chemo gloves, recommended: mask with P100 filter or N95 NIOSH certified.

Ø If a container broken leave it in its shipping bag:A. Call company and see if you can return item or dispose of appropriately and decontaminate the

area.

OR

B. If the container is a multipack: don required PPE, safely transport the HD to an appropriate HD hood, take out the non-damaged containers, decontaminate, and place in storage.

StorageØ Off the floor and lipped shelves if in an earthquake prone area.

Ø HDs in their final form for dispensing they should be segregated from non-HD drugs.

Ø Antineoplastics for manipulation or any Bulk API must be stored separately from non-HDs.

§ API for compounding may be stored in the compounding area:• Sterile API in HD buffer room• Sterile or non-sterile API in HD non-sterile compounding area

§ Antineoplastics for manipulation or any Bulk API storage requirements:• Externally vented and negative pressure• 12 air changes per hour (ACPH)

• Dedicated refrigerator for temperature sensitive HDs

CompoundingBoth sterile and non-sterile compounding must be performed in a containment primary engineering control (C-PEC) within containment secondary engineering control (C-SEC). C-SECs must:Ø Be externally vented through high-efficiency particulate air (HEPA) filtration.

Ø Be physically separated (i.e. a room with doors, separate from other areas of the pharmacy).

Ø Have an appropriate ACPH.

Ø Have a negative pressure between 0.01 and 0.03 inches of water column (in) relative to all adjacent areas.

A sink for hand washing and an eyewash station must be available

Equipment must be dedicated to HD compounding (scales, spatulas, mortar & pestles, etc.)

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Containment Primary Engineering Controls (C-PEC)Containment Ventilated Enclosure (CVE)Ø Weighing/measuring materials or non-sterile

compounding

Biological Safety Cabinet (BSC)Ø May be used for sterile or non-sterile

compounding depending on BSC class

Compounding Aseptic Containment Isolator (CACI)Ø May be used for sterile or non-sterile

compounding

Class II Biological Safety Cabinets (BSC)A1Ø HEPA filtered air is partially recirculated within

cabinet and partially vented within room* Not for volatile HDs

A2/B1Ø HEPA filtered air is partially recirculated within

cabinet and partially externally vented

B2Ø HEPA filtered air is completely externally

vented

Class II BCS Type A2 & B1

Non-Sterile CompoundingØ Room must be physically separated from

other preparation areas.

Ø All surfaces of the room must be area must be smooth, impervious, free from cracks and crevices, and non-shedding.

Ø If only occasionally compounding non-sterile HDs, compounding may be performed in a C-PEC used for sterile compounding but it may not take place during sterile compounding and must be appropriately decontaminated, cleaned, and disinfected before use.

C-PEC C-SEC

Externally vented (preferred) or redundant HEPA filtered in series

Externally vented

Negative pressure 0.01 to 0.03 in

CVE, Class I or II BSC, CACI

12 ACPH

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Sterile Compounding

Configuration C-PEC S-SEC

ISO Class 7 buffer room with

an ISO Class 7 ante-room

(Category 2)

• Externally vented

• Class II BSC or CACI

• Externally vented

• 30 ACPH

• Negative pressure 0.01 to 0.03 in

Unclassified C-SCA

(Category 1)

• Externally vented

• Class II BSC or CACI

• Externally vented

• 12 ACPH

• Negative pressure 0.01 to 0.03 in

Room Requirements:

Sterile Compounding pt. 2ØMust follow standards set forth in USP <797>.

ØHD PPE must be removed before leaving room.§ A HD buffer room off of a positive pressure buffer room must have a line-of-demarcation.

ØA plastic backed mat is recommended to be placed on the DCA of the C-PEC.

Compounding Sequence1. Stage materials2. Prepare compounding area

3. Compound preparation(s)4. Clean outside of container and place in a non-contaminated location

5. Remove outer chemotherapy gloves6. Apply label7. Deactivate, Decontaminate, Clean, Disinfect

Not Recommended

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DispensingØ Antineoplastic tablets and capsules must not be placed in an automated

counting or packaging machine.Ø Equipment for counting or measuring HDs must be dedicated for HD use

and decontaminated after every use.Ø Labels are required to have all of the normal medication information plus

storage instructions, disposal instructions, and HD category information.

Ø Packaging must maintain HD physical integrity, stability and sterility.

Ø Packaging must protect HD from damage, leakage, contamination, and degradation, while protecting healthcare workers who transport HDs.

TransportØ Must be labeled, stored, and handled in accordance with applicable federal,

state, and local regulations.Ø SDS of HD must be consulted for transport information.Ø Must be transported in containers that minimize the risk of breakage or

leakage.Ø Must follow carrier’s policies.

** Liquid HDs and Antineoplastics must notbe transported in Pneumatic tubes **

AdministrationØ HDs must be administered safely using protective medical devices and

techniques.§ Close System Transfer Device (CSTD)§ Crushing tablets a plastic pouch§ Priming IV tubing with non-HD solution in C-PEC

Ø CSTDs must be used for administration of antineoplastic HDs when the dosage form allows.

Ø Appropriate PPE must be worn depending on dosage form and administration.

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Hazardous Drug ConsiderationsBendamustine: TreandaØ NIOSH Classification: Group 1 AntineoplasticØ Form: Injection solutionØ Equipment compatibility: Dissolves polycarbonate or nitrile-butadiene-styrene found in

some syringes, IV systems, and CSTDs

Cyclophosphamide: CytoxanØ NIOSH Classification: Group 1 AntineoplasticØ Form: Lyophilized powder for injection (20mg/mL) or tabletØ Contamination: Concentrations ≥ 1ng/cm2 leads to dermal uptake in exposed personnelØ Testing: Common target for contamination test wipe kits

Hazardous Drug Considerations pt. 2Hormones: Testosterone and Estrogen

Ø NIOSH Classification: Group 3 and Group 2 respectively

Ø Form: Bulk API Powder

Ø Handling: Must be treated the same as an Antineoplastic

Ø Controls: Stored in a separate room with external ventilation, with negative pressure, and 12 ACPH. Compounded in a C-PEC in a separate room with external ventilation, negative pressure

0.01 to 0.03 in, and 12 ACPH(30 ACPH for sterile compounding).

Warfarin: Coumadin

Ø NIOSH Classification: Group 3 Non-antineoplastic with reproductive risks

Ø Form: Tablet

Ø Disposal: P001 Hazardous Waste – Waste with warfarin residue must be disposed of through an appropriate collection site.

Hazardous Drug Considerations pt. 3Volatile Hazardous Drugs: (all are Group 1: Antineoplastic Drugs)

Ø CarmustineØ Mustargen (Mechlorethamine)Ø IfosfamideØ CyclophosphamideØ DoxorubicinØ Thiotepa

These appropriate PPE for handling these drugs includes a full-facepiece, chemical cartridge-type respirator or a powered air-purifying respirator (PAPR) when manipulating out side of a C-PEC, depending on the type and method of administration, and for spill management and cleanup.

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SummaryØ United States Pharmacopeia-National Formulary (USP) is constantly researching and

updating standards for Pharmacists and other Health Care Workers to follow.

Ø USP <797> is being updated to include new sterile compounding standards, clarify current standards, reorganize the chapter, and to remove handling requirements of specialty drugs (Hazardous and Radiopharmaceuticals).

Ø USP <800> sets forth standards for safe handling, storage, transport and administration of Hazardous drugs including requirements for:Ø Personal Protective Equipment

Ø Storage ConditionsØ Facility Controls

Ø Cleaning and Spill Management

December 1, 2019, USP <795, 797, 800, 825> Scheduled to go into Effect

Thank You

?¿? QUESTIONS ¿?¿

ResourcesUSP <797> Information: http://www.usp.org/compounding/general-chapter-797

USP <797> Revisions PDF: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf

USP <800> Information: http://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare

NIOSH Hazardous Drugs: https://www.cdc.gov/niosh/topics/hazdrug/default.html

OSHA Hazardous Drug Handling: https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html

EPA Hazardous Drug Waste: https://www.epa.gov/hwgenerators/management-pharmaceutical-hazardous-waste

Critical Point and their Gap Analysis: https://www.criticalpoint.info/, http://www.800gaptool.com/

Joint Commission Resources Self Assessment for Hazardous Drug Handling: https://hazmedsafety.com/en/qualify

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https://www.walm art.com /ip/Distribution-Container-W ith-Hinged-Lid-21-7-8x15-1-4x9-11-16-Red-Lot-of-1/367100319

https://blogs.cdc.gov/niosh-science-blog /2014/05/21/hazardous-drugs/

https://en.wikipedia.org/wiki/Pharmacist

https://www.medicinenet.com /chronic_rhinitis/article.htm#where_are_the_sinuses_and_what_do_they_look_like

http://www.usp.org /compounding/updates-on-standards

https://www.maxxamlabs.com/services/pharmaceutical-industrial-hygiene/chemoalert/

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https://www.nuaire.com/pharmagard-es-nu-nte800-total-exhaust-compounding-aseptic-containment-isolator

https://www.researchgate.net/publication/275714964_Validation_of_biological_safety_cabinet_BSC

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