#1 THINGS YOU NEED TO KNOW Go Live Date Christina Coleman Kim, - - PDF document

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10/4/18 1 USP <800>

THE TOP 10 THINGS YOU NEED TO KNOW

Christina Coleman Kim, PharmD University of New Mexico Hospitals

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#1

Go Live Date

Christina Kim

• DECEMBER 1, 2019
• New Mexico Board of Pharmacy is currently re-

writing Title 16, Chapter 19, Part 30 (Compounding

• f Non-Sterile Pharmaceuticals) and Part 36

(Compounded Sterile Preparations) to include USP <800> regulations

• What does this mean for hazardous compounding in

New Mexico facilities?

• We have approximately 14 months to bring our

facilities into compliance with the new regulations

• The New Mexico Board of Pharmacy will require

compliance and will be inspecting for compliance as of December 1, 2019.

• Get it done early because you’ll have a lot of

people to reach out to!

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GO LIVE INFORMATION

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#2

Introduction and Scope

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• WHAT ARE WE DISCUSSING?
• Handling Hazardous Drugs (HDs)
• WHY ARE WE DISCUSSING HANDLING

HAZARDOUS DRUGS?

• To create standards for handling because we care

about patient safety, employee safety and protecting the environment

• WHO IS AFFECTED?
• Anyone and any institution that handles HD

preparations

• SHARE WHAT WE HAVE AT UNMH

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INTRODUCTION AND SCOPE

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#3

Designated Person

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• RESPONSIBILITIES OF DESIGNATED PERSON
• Qualified and trained
• Oversee compliance with USP <800> as well as other applicable

laws and regulations

• Competency of personnel
• Environmental control of storage and compounding areas
• Oversight of facility including testing and monitoring
• Maintaining documentation
• DOES THE “DESIGNATED PERSON” HAVE TO DO

EVERYTHING?

• No, form an interdisciplinary team consisting of nurses,

pharmacists, pharmacy technicians, physicians, veterinarians, safety personnel, environmental services personnel, etc.

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DESIGNATED PERSON TO MANAGE THE PROGRAM

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#4

LIST OF HAZARDOUS DRUGS

Christina Kim

• ENTITY MUST CREATE AND MAINTAIN A LIST OF HDs
• A list of HDs is maintained by The National Institute for

Occupational Safety and Health (NIOSH)

• Group 1: Antineoplastic Drugs which may pose a reproductive

risk for susceptible populations

• Group 2: Non-antineoplastic drugs that meet one or more of

the NIOSH criteria for a hazardous drug and may also pose a reproductive risk for susceptible populations

• Group 3: Drugs that pose a reproductive risk to both men and

women who are actively trying to conceive and women who are breast feeding

• NIOSH 2016 List plus a proposed addition list for 2018
• Practice-specific assessment of HDs which is evaluated yearly or

whenever a new agent is added to the formulary

• Perform an assessment of risk of the drugs on your list to

determine how to handle HDs

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LIST OF HAZARDOUS DRUGS

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• IT IS ADVISEABLE TO PERFORM AN ASSESSMENT OF RISK

(AOR) OF ALL DRUGS ON YOUR HAZARDOUS DRUG LIST

• Why? Provides for alternative containment strategies and

work practices.

• HDs on the NIOSH List that must follow containment

requirements of USP <800> regardless of AOR include

• Any HD API
• Any antineoplastic requiring manipulation
• Alternative containment strategies and work practices are

allowed for drugs on the NIOSH list if an AOR is completed

• Final dosage forms of compounded HD preparations
• Conventionally manufactured HD products that do

not require any further manipulation

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ASSESSMENT OF RISK

Christina Kim

• TOPICS TO INCLUDE IN THE AOR:
• 1. Type of HD
• 2. Dosage form (Every form of every drug on the NIOSH list)
• 3. Risk of exposure
• 4. Packaging
• 5. Manipulation
• 6. Administration (PPE)
• EXAMPLES
• 1. Final dosage form of compounded antineoplastics (An

AOR may reveal the need for less restrictive storage requirements)

• 2. Finasteride (crushing tablets on the floor) (An AOR may

reveal the need for more restrictive requirements.)

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ASSESSMENT OF RISK

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Step 1: Create an Algorithm

12 NIOSH Table 2 or is carcinogenic, genotoxic, or organ toxic (per criteria in NIOSH guidelines)

Injectable Requires drawing from ampule or vial? Yes: Storage: Standard Hood: C-PEC Pharmacy garb: Full PPE Hand delivery non-chemo Nursing Garb: Chemo gloves No, in final dosage form: Storage: Pyxis Hood: N/A Pharmacy garb: N/A Delivery: OK to tube Nursing Garb: Chemo gloves Solution, Topical Requires manipulation such as mixing? Yes: Storage: Standard Hood: C-PEC Pharmacy garb: Full PPE Hand Delivery non-chemo Nursing Garb: Chemo gloves If not, then it's in its final dosage form Storage: Pyxis Hood: N/A Pharmacy garb: N/A Delivery: OK to tube Nursing garb: Chemo gloves Tablet, Capsule Requires manipulation sucRequires manipulation such as crushing or splitting tablets or opening capsules? Yes: Storage: Standard Hood: C-PEC Pharmacy garb: Full PPE Hand Delivery non-chemo Nursing Garb: Chemo gloves If not, then it's in its final dosage form Storage: Pyxis Hood: N/A Pharmacy garb: N/A Delivery: OK to tube Nursing garb: Chemo gloves

• Present it to your group and discuss
• Pick what factors are important and come

up with a consistent set of rules

• You could try to evaluate each drug and

each form one-by-one

• After you include all of the forms of each

drug you are looking at a list 300 lines long!

• That’s too much for a group discussion
• Dividing and conquering list-by-list can

lead to inconsistency

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Step 2: Load Your Algorithm Rules into Excel

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• The NIOSH list is not Excel friendly but you can do it!
• Make a bunch of If-Then Statements in Excel based on the

algorithm your group decided on and just drag it through your NIOSH Excel

• You will end up with a big, overwhelming Excel sheet that
• nly the safety nerds will appreciate
• It will only take one, hour-long meeting for the algorithm
• From there give one person about two extra hours to set up

the Excel and you’re done!

• If you want to change the algorithm later, just update the

Excel rules!

Christina Kim 14 UNMH Assessment of Risk

• Do not crush or open any forms of drugs on this list on a nursing unit or anywhere outside of a pharmacy Hazardous hood.
• When administration of a drug requires that pharmacy manipulate any nonsterile HD on this list such as splitting tablets, crushing tablets or opening capsules to create a

slurry, administering personnel must wear two pairs of gloves and a gown.

• The information in this list can be found on the MAR and Pyxis stations.
• Most NIOSH Group 1 drugs are cytotoxic chemotherapy. Cytotoxic drugs will be stickered with a yellow warning sticker that states, "CYTOTOXIC MATERIAL HANDLE PROPERLY."
• NIOSH Group 2 drugs are non-antineoplastic drugs that meet one or more of the NIOSH criteria for an HD, some of these HDs may pose a reproductive risk for susceptible

populations.

• NIOSH Group 3 drugs primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding.
• Solid form drugs generally pose less risk of exposure than injectable and non-solid form drugs and thus are handled differently.

Drug Information Pharmacy Handling Nursing Unit Handling Additional Information

Generic Name (Brand Name) Usual Route Formulation Pharmacy Storage Pharmacy protection (PPE) for Manipulati

• n

What type

• f Hood to

Prepare (Manipulate ) Dispense from Pharmacy Disposa l Delivery Nursing Garb (PPE) Storage in Pyxis? Excrement /Urine Disposal Supplemental information Pregnancy Category NIOSH Group MSHG AHFS classificat ion abiraterone Oral Tablet Pyxis or Standard Haz garb Haz Hood Standard Hand Delivery, but do not tube Black bucket Standard Hand Delivery, but do not tube One pair of gloves Pyxis or Standard Protect from urine/exc rement for 48h Black bucket Women who are pregnant

• r may be pregnant

should not handle without protection (e.g., gloves) X Antineopla stic Group 1 10:00 antineoplas tic agents ado- trastuzumab emtansine IV Injection Haz Room Haz garb and use Equashield Haz Hood Hand Deliver in Chemo bag Black bucket Hand Deliver in Chemo bag Double glove and gown Hand Delivery in Chemo bag Protect from urine/exc rement for 48h Black bucket Conjugated monoclonal antibody D Antineopla stic Group 1 yes 10:00 antineoplas tic agents afatinib* Oral Tablet Pyxis or Standard Haz garb Haz Hood Standard Hand Delivery, but do not tube Black bucket Standard Hand Delivery, but do not tube One pair of gloves Pyxis or Standard Protect from urine/exc rement for 48h Black bucket Special warnings on contraception for females while taking and 2 weeks post- treatment D Antineopla stic Group 1 10:00 antineoplas tic agents altretamine Oral Capsule Pyxis or Standard Haz garb Haz Hood Standard Hand Delivery, but do not tube Black bucket Standard Hand Delivery, but do not tube One pair of gloves Pyxis or Standard Protect from urine/exc rement for 48h Black bucket D Antineopla stic Group 1 yes 10:00 antineoplas tic agents amsacrine IV Injection Haz Room Haz garb and use Equashield Haz Hood Hand Deliver in Chemo bag Black bucket Hand Deliver in Chemo bag Double glove and gown Hand Delivery in Chemo bag Protect from urine/exc rement for 48h Black bucket IARC Group 2B† Antineopla stic Group 1 yes NA antineoplas tic agents anastrozole Oral Tablet Pyxis or Standard Haz garb Haz Hood Standard Hand Delivery, but do not tube Black bucket Standard Hand Delivery, but do not tube One pair of gloves Pyxis or Standard Protect from urine/exc rement for 48h Black bucket X Antineopla stic Group 1 10:00 antineoplas tic agents arsenic trioxide IV Injection Haz Room Haz garb and use Equashield Haz Hood Hand Deliver in Chemo bag Areseni c bucket Hand Deliver in Chemo bag Double glove and gown Hand Delivery in Chemo bag Protect from urine/exc rement for 48h Return to pharmacy for disposal in arsenic bucket IARC Group 1 carcinogen; NTP** D Antineopla stic Group 1 yes 10:00 antineoplas tic agents axitinib Oral Tablet Pyxis or Standard Haz garb Haz Hood Standard Hand Delivery, but do not tube Black bucket Standard Hand Delivery, but do not tube One pair of gloves Pyxis or Standard Protect from urine/exc rement for 48h Black bucket Teratogenic, embryotoxic and fetotoxic in mice at exposures lower than human exposures D Antineopla stic Group 1 10:00 antineoplas tic agents azacitidine IV Injection Haz Room Haz garb and use Equashield Haz Hood Hand Deliver in Chemo bag Black bucket Hand Deliver in Chemo bag Double glove and gown Hand Delivery in Chemo bag Protect from urine/exc rement for 48h Black bucket IARC Group 2A carcinogen; NTP*** D Antineopla stic Group 1 yes 10:00 antineoplas tic agents Bacillus Calmette Guerin (BCG) Cathete r Injection Haz Room Haz garb and use Equashield Haz Hood Hand Deliver in Chemo bag Black bucket Hand Deliver in Chemo bag Double glove and gown Hand Delivery in Chemo bag Protect from urine/exc rement for 48h Black bucket See special handling requirements‡; FDA Pregnancy Category C C Antineopla stic Group 1 yes 80:12 vaccines

Christina Kim

Step 3 Collaborate!

This is a Great Way to Get Pharmacy out there in your Facility!

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• Use it as an excuse to get on agendas and network!
• Adult Nurse/Pharmacy
• Peds Nurse/Pharmacy
• Med Safety
• Safety Directors meeting
• Clin Ed
• PPG
• Management Coffee
• Make sure its safe AND practical!
• Participate in Nursing Education on USP 800!
• Build it into your MAR and on to Pyxis
• Work with IT and make it nursing-friendly!

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#5

RECEIVING HDs

Christina Kim

PROCEDURE REQUIRED FOR RECEIVING HDS

• 1. Visually examine the shipping container for signs of

damage or breakage and follow entity’s developed procedure for handling damaged or broken containers

• 2. The supplier should package HDs in impervious plastic to

segregate them from other drugs. Leave the HDs in the plastic and deliver to the HD storage area for further unpacking

• 3. PPE, including chemotherapy gloves, must be worn when

unpacking (This is where the AOR comes in to play)

• 4. Remove HDs from their external shipping containers in an

area that is neutral or negative pressure relative to the surrounding areas.

• 5. Do not unpack in the sterile compounding area or in any

positive pressure area

• 6. A spill kit must be accessible in the receiving area

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REQUIREMENTS FOR RECEIVING HDs

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#6

STORING HDs

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PROCEDURE REQUIRED FOR STORING HDs

• 1. Do not store on the floor. Store on secure shelves

with raised front lips to prevent falling and breaking

• 2. Antineoplastic HDs and HD API requiring physical

manipulation must be stored in an externally vented, negative pressure room with at least 12 air changes per hour (ACPH). Example: Hazardous Ante or Clean room

• 3. Non-antineoplastic, reproductive risk only, and final

dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy. Examples: methotrexate, finasteride and warfarin tabs

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REQUIREMENTS FOR STORING HDs

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PROCEDURE REQUIRED FOR STORING HDs

• 4. Refrigerated antineoplastic HDs must be stored in a dedicated

refrigerator in a negative pressure area with at least 12

• ACPH. Examples: storage room, buffer (clean) room or

containment segregated compounding area (C-SCA). Note: It is recommended to place the refrigerator in front of an exhaust vent if the refrigerator is located in a negative pressure buffer (clean) room

• 5. The most simple approach to take (if your procedures allows)

is to store sterile HDs that require manipulation in a properly designed storage room, hazardous ante or clean room or the C-SCA. Store non-sterile HDs such as tablets or suspensions with other inventory

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REQUIREMENTS FOR STORING HDs

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#7

COMPOUNDING HDs

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PRACTICAL APPROACH TO COMPOUNDING

• Training
• Personal Protective Equipment
• Facilities and Engineering Controls
• Containment Supplemental Engineering

Controls

• Non-sterile compounding

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COMPOUNDING

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Engineering Controls: NIOSH/OSHA term that describes a barrier between the worker and HD

• Primary Engineering Control:
• Containment Primary Engineering Control (C-PEC):

Haz-hood

• Secondary Engineering Control:
• Containment Secondary Engineering Control (C-SEC):

Haz-room

• Containment segregated compounding area (C-SCA):

Basically a less sterile C-SEC

• Unclassified area: Everywhere else in the world
• Supplemental Engineering Control: Closed-System Drug-

Transfer Device (CSTD)

• Equashield, Phaseal, etc

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Definitions

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TRAINING

STERILE HAZARDOUS COMPOUNDING

• 1. TRAINING IN NON-HAZARDOUS STERILE COMPOUNDING IS REQUIRED PRIOR TO

BEGINNING HAZARDOUS STERILE COMPOUNDING TRAINING

• 2. Once non-hazardous compounding training is complete and employee demonstrates

competency then hazardous compounding training can begin

• 3. The following are required areas of training for any type of hazardous compounding:
• Overview of entity’s list of HDs and risks
• Review of the entity’s policies and procedures for handling HDs
• Proper Use of Personal Protective Equipment
• Proper Use of equipment and devices
• Response to known or suspected HD exposure
• Spill Management
• Proper disposal of HDs and trace-contaminated materials

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PERSONAL PROTECTIVE EQUIPMENT

• 1. GLOVES [American Society for Testing and Materials (ASTM) D6978]
• Two pairs of gloves are required. The outside gloves must be sterile
• Change gloves every 30 minutes or when torn, punctured or contaminated
• Wash hands with soap and water after removing gloves
• 2. GOWNS [Polyethylene-coated polypropylene or other laminate materials]
• Disposable
• Long sleeved
• Close in the back (tie in the back)
• Closed cuffs that are elastic or knit
• Change every 2-3 hours or per the manufacturer’s information. Change immediately

after a spill or splash

• Do not wear the gown outside of the hazardous medication preparation area

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PERSONAL PROTECTIVE EQUIPMENT

• 3. HEAD, HAIR, SHOE, AND SLEEVE COVERS
• Cover head and hair. Cover beard and moustache with a beard cover
• When entering the hazardous compounding area a second set of shoe covers

must be donned before entering and doffed when exiting the compounding area

• Disposable sleeve covers may be used (polyethylene-coated polypropylene or
• ther laminate materials offer better protection
• 4. EYE AND FACE PROTECTION
• Eye protection is typically not used when compounding inside an appropriate biological safety cabinet
• However, goggles must be worn when eye protection is needed
• Face shields in combination with goggles provide full protection against splashes to the eyes and face

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PERSONAL PROTECTIVE EQUIPMENT

• 5. RESPIRATORY PROTECTION
• Interestingly enough – USP <800> doesn’t give a recommendation for respiratory protection if

working with a face shield in an appropriate biological safety cabinet

• USP <800> does state that “surgical masks do not provide respiratory protection from drug exposure and must

not be used when respiratory protection from HD exposure is required”

• Remember a mask ensures sterility of the product but even an N-95 doesn’t do much to protect the worker
• 6. DISPOSAL OF PPE USED DURING COMPOUNDING
• Place in an appropriate waste container inside the containment secondary engineering control area (C-

SEC) also known as the hazardous clean room and dispose of per local, state, and federal regulations

• Remove chemotherapy gloves and sleeve covers used during compounding and discard immediately

into an appropriate waste container inside the contained primary engineering control unit (C-PEC). You may also place gloves and sleeves into a sealable bag and discard into an appropriate waste container outside of the C-PEC such as an appropriate container located in the C-SEC. This second

• ption is a little more practical due to space inside the C-PEC
• Need to don PPE upon entering and doff PPE BEFORE leaving the haz room
• Can’t run things out of the Haz room and re-enter anymore

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FACILITIES AND ENGINEERING CONTROLS

In order to compound appropriately and safely understand the facility, design and engineering controls is crucial

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USP <797> AND <800> FACILITY DESIGN FOR STERILE COMPOUNDING

NEGATIVE PRESSURE – ISO 7 – HAZARDOUS COMPOUNDING EXTERNALLY VENTED TO OUTSIDE AIR SHARED ANTE ROOM – ISO 7 POSITIVE PRESSURE BUFFER ROOM – ISO 7 – NON-HAZARDOUS COMPOUNDING – RECIRCULATE AIR THROUGH HEPA FILTERS OR VENT TO THE OUTSIDE

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Laminar Air Flow Hood (LAFH) Class II B2 BSC ISO 5

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USP <797> AND <800> FACILITY DESIGN FOR HD STERILE COMPOUNDING – Unclassified Containment-Segregated Compounding Area (C-SCA) – Requires 12 hour BUD

NEGATIVE PRESSURE – Relative to adjacent area (0.01 – 0.03 in WC) EXTERNALLY VENTED TO OUTSIDE AIR

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Class II B2 BSC

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PRIMARY ENGINEERING CONTROL

Containment Primary Engineering Controls (C-PECS) NOT ALLOWED for STERILE compounding of HDs

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Laminar Air Flow Hood (LAFH) Containment Ventilated Enclosure (CVE) Can be used for Non- Sterile Compounding Class 1 BSC Fume Hood (protects worker but not product)

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PRIMARY ENGINEERING CONTROL

Containment Primary Engineering Controls (C-PECS) ALLOWED for STERILE compounding of HDs

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Containment Ventilated Enclosure (CVE) Can be used for Non- Sterile Compounding

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Compounding aseptic containment isolator (CACI)

• Note that 797 update will require that you put disposable gloves on

your hands, then put your gloved hands into the gloves then put gloves on top of the gloves

• 3 pair of gloves!
• You still need to put it into a negative pressure room

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PRIMARY ENGINEERING CONTROL – One more!

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CONTAINMENT SUPPLEMENTAL ENGINEERING CONTROLS (CSTDs)

Keyword: Supplemental Not a substitute for a C-PEC

• Offer an additional level of protection during compounding and administration
• A “Should” for preparation, but a “Must” for administration?
• Many Brands in the Marketplace. Examples:
• Equashield
• Icumedical – ChemoLock
• BD Phaseal
• Tevadaptor

COMPOUNDING ADMINISTRATION

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NON-STERILE COMPOUNDING

• Must also follow standards set in Pharmaceutical Compounding-Nonsterile Preparations <795>
• Handling of final dosage forms in a C-PEC is not required unless you are manipulating in such a way that produces

particles, aerosols or gasses

• If you are manipulating a non-sterile HD then the following table is helpful to determine where to compound:
• A C-PEC designated for sterile compounding may be used to occasionally compound non-sterile HD. However, the C-

PEC must be decontaminated, cleaned and disinfected before resuming sterile compounding

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Engineering Controls for Nonsterile HD Compounding C-PEC Requirements C-SEC Requirements

• Externally vented

(preferred) or redundant- HEPA filtered in series

• Examples: CVE, Class I or

II BSC, CACI

• Externally vented
• 12 ACPH
• Negative Pressure (0.01

and 0.03 inches of water column) relative to adjacent areas

Christina Kim

Engineering Controls: Preferred ISO Class 7 buffer room with ISO Class 7 ante room

• Not recommended to enter the haz room through the non-haz

room (ante-room preferred)

• But if you do, a method of transportation of HDs is
• required. It’s basically required to have a pass-through
• Wipe sampling twice per year
• Talk with your CSTD rep ;)

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Other Recommendations

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#8

ADMINISTERING HDs

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• No NIOSH medication should be crushed on the units?
• What about paediatric patient education (methotrexate)?
• It’s a SHOULD NOT in USP 800, use a plastic pouch and PPE if

absolutely necessary

• Now you have a Do-Not Crush list and the NIOSH list
• Time to put this info onto the MAR and Pyxis
• Use CSTDs for administration when possible (It’s mandatory)
• Have Chemo-experienced nurses float to administer chemo
• PPE: all of our gloves at UNMH are “Chemo gloves”
• 2 pair for anti-neoplastic HDs
• 2 versus 1 for the rest depends on your assessment of risk
• Eye, face, and respiration protection is optional
• Refer to Oncology Nursing Society guidelines ONS for more

details on PPE

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Help the Nurses!

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#9

SPILL CONTROL of HDs

Christina Kim

In addition to PPE requirements described, its up to you to work with work with EVS and Safety on this one!

• Develop SOPs and train your staff

At UNMH

• Our Spill SOP is built into our USP 800 guideline
• Double-bag contaminated linen blue then yellow on the outside
• Spills less than 5ml
• No spill kit necessary
• Spills greater than 5ml
• Use a spill kit

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Spills!

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#10

MEDICAL SURVEILLANCE

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• Does every person exposed to chemo need a trip to the ED?
• Consider running this by the ED before putting it in writing!
• Be careful who you mandate goes to the ED
• Our ED does not feel every drop of chemo requires an

emergency visit

• Eye exposure, ingestion, symptomatic skin and symptomatic

inhalation require immediate treatment

• Send patients, visitors and workers to Oc Health or ED
• Injections, rectal, nasal exposure, need immediate help as

well

• Work with your Occupational Health team

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Accidental Exposure!

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Conclusion

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USP 800 is a big deal and its our time to shine!

• Recruit a multidisciplinary team
• Come up with your own procedure and make it practical and

specific for your institution

• Parade around your work!
• Use it as a networking opportunity for your department and
• ur profession!

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Wow them with Pharmacy!

Christina Kim

References

1. NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016- 161. 2. New Mexico Board of Pharmacy Regulation. Title 16: Occupational and Professional Licensing. Chapter 19: Pharmacists. Part 30: Compounding of Non-Sterile Pharmaceuticals 3. New Mexico Board of Pharmacy Regulation. Title 16: Occupational and Professional Licensing. Chapter 19: Pharmacists. Part 36: Compounded Sterile Preparations 4. <800> Hazardous Drugs – Handling in Healthcare Settings. United States Pharmacopoeia.

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Thank You

CCKIM@SALUD.UNM.EDU