Compounding Pharmacy Inspection

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• PIC or Pharmacy Contact

• Location
  Address

• Start Time

  Date

• End Time

  Date

• Address

• Phone Number (patient facing)

• Fax number (doctor facing)

• Website

• Hours of Operation

• Pharmacist in Charge

• Non-Sterile Designated person

• Sterile Designated person

• Hazardous Designated person

• Personnel present at time of inspection?

• All personnel wearing name tags?

  Compliant

  Non-Compliant

  N/A

• All personnel's licenses visible to the public and not expired?

  Compliant

  Non-Compliant

  N/A

• Total Pharmacists

• Number of Compounding Pharmacists

• Total Student Interns

• Total Technicians

• Number of Compounding Technicians

• Of the technicians, how many are CPht?

• Of the technicians, how many are techs-in-training?

• Total other Unlicensed Personnel

• Ratio of Technicians : Pharmacists

• Pharmacy License(s), DEA, and other business licenses visible to the public and not expired?

  Compliant

  Non-Compliant

  N/A

• Type of Practice

  Select Traditional Retail Open to the Public Closed Door Drive Through Window Mail/Ship in-state Mail/Ship Out-of-state Local Delivery Veterinary Pharmacy Long-term Care Investigational Drugs, Clinical Trials/Research Telepharmacy Internet Pharmacy Central fill/Shared Services Nuclear Pharmacy Specialty Pharmacy White bagging/clear bagging Outsourcing facility Wholesale Distributor Provide prescription drugs for "Office Use" Handles Medical Marijuana Non-sterile Compounding Non-sterile Hazardous Compounding Sterile Compounding Sterile Hazardous Compounding

  • Traditional Retail
  • Open to the Public
  • Closed Door
  • Drive Through Window
  • Mail/Ship in-state
  • Mail/Ship Out-of-state
  • Local Delivery
  • Veterinary Pharmacy
  • Long-term Care
  • Investigational Drugs, Clinical Trials/Research
  • Telepharmacy
  • Internet Pharmacy
  • Central fill/Shared Services
  • Nuclear Pharmacy
  • Specialty Pharmacy
  • White bagging/clear bagging
  • Outsourcing facility
  • Wholesale Distributor
  • Provide prescription drugs for "Office Use"
  • Handles Medical Marijuana
  • Non-sterile Compounding
  • Non-sterile Hazardous Compounding
  • Sterile Compounding
  • Sterile Hazardous Compounding

• Compounded Nonsterile Preparations (CNSPs)

  Select CNSPs with controlled substances CNSPs with vitamins or nutritional supplements CNSPs sold to other pharmacies Patient specific CNSPs for animals Patient specific CNSPs for humans Non-patient specific CNSPs for animals Non-patient specific CNSPs for humans CNSPs to practitioners for office use CNSPs to hospitals, clinics, or surgery centers

  • CNSPs with controlled substances
  • CNSPs with vitamins or nutritional supplements
  • CNSPs sold to other pharmacies
  • Patient specific CNSPs for animals
  • Patient specific CNSPs for humans
  • Non-patient specific CNSPs for animals
  • Non-patient specific CNSPs for humans
  • CNSPs to practitioners for office use
  • CNSPs to hospitals, clinics, or surgery centers

• Compounded Sterile Preparations (CSPs)

  Select CSPs with Controlled Substances CSPs with Vitamins or Nutritional supplements CSPs sold to other pharmacies Patient specific CSPs for Animals Patient specific CSPs for Humans Non-patient specific CSPs for animals Non-patient specific CSPs for humans CSPs to practitioners for office use CSPs to hospitals, clinics, or surgery centers

  • CSPs with Controlled Substances
  • CSPs with Vitamins or Nutritional supplements
  • CSPs sold to other pharmacies
  • Patient specific CSPs for Animals
  • Patient specific CSPs for Humans
  • Non-patient specific CSPs for animals
  • Non-patient specific CSPs for humans
  • CSPs to practitioners for office use
  • CSPs to hospitals, clinics, or surgery centers

• Types of CNSPs

  Select Aqueous Nonaqueous Solid oral preparations (i.e. capsules) Liquid oral preparations Otic preparations Rectal preparations Vaginal preparations Topical preparations Nasal and sinus preparations Other (list in notes)

  • Aqueous
  • Nonaqueous
  • Solid oral preparations (i.e. capsules)
  • Liquid oral preparations
  • Otic preparations
  • Rectal preparations
  • Vaginal preparations
  • Topical preparations
  • Nasal and sinus preparations
  • Other (list in notes)

• Types of CSPs

  Select Category 1 CSPs Category 2 CSPs Category 3 CSPs Allergenic extracts Immediate Use Proprietary bag and vial systems Blood-derived or other biologic material (autologous serum) Sterile injections/sterile infusions Ophthalmic dosage forms Baths and soaks for live organs and tissues Implants/Pellets Other (list in notes)

  • Category 1 CSPs
  • Category 2 CSPs
  • Category 3 CSPs
  • Allergenic extracts
  • Immediate Use
  • Proprietary bag and vial systems
  • Blood-derived or other biologic material (autologous serum)
  • Sterile injections/sterile infusions
  • Ophthalmic dosage forms
  • Baths and soaks for live organs and tissues
  • Implants/Pellets
  • Other (list in notes)

• Total prescriptions dispensed per day

• % Veterinary Prescriptions

• % Controlled substance prescriptions

• % Non-sterile compounded prescriptions

• % Sterile compounded prescriptions

• % HD prescriptions

State licenses

• Select the states licensed

  Select Alabama (AL) Alaska (AK) Arizona (AZ) Arkansas (AR) California (CA) Colorado (CO) Connecticut (CT) Delaware (DE) District of Columbia (DC) Florida (FL) Georgia (GA) Hawaii (HI) Idaho (ID) Illinois (IL) Indiana (IN) Iowa (IA) Kansas (KS) Kentucky (KY) Louisiana (LA) Maine (ME) Maryland (MD) Massachusetts (MA) Michigan (MI) Minnesota (MN) Mississippi (MS) Missouri (MO) Montana (MT) Nebraska (NE) Nevada (NV) New Hampshire (NH) New Jersey (NJ) New Mexico (NM) New York (NY) North Carolina (NC) North Dakota (ND) Ohio (OH) Oklahoma (OK) Oregon (OR) Pennsylvania (PA) Rhode Island (RI) South Carolina (SC) South Dakota (SD) Tennessee (TN) Texas (TX) Utah (UT) Vermont (VT) Virginia (VA) Washington (WA) West Virginia (WV) Wisconsin (WI) Wyoming (WY) Other (put in notes)

  • Alabama (AL)
  • Alaska (AK)
  • Arizona (AZ)
  • Arkansas (AR)
  • California (CA)
  • Colorado (CO)
  • Connecticut (CT)
  • Delaware (DE)
  • District of Columbia (DC)
  • Florida (FL)
  • Georgia (GA)
  • Hawaii (HI)
  • Idaho (ID)
  • Illinois (IL)
  • Indiana (IN)
  • Iowa (IA)
  • Kansas (KS)
  • Kentucky (KY)
  • Louisiana (LA)
  • Maine (ME)
  • Maryland (MD)
  • Massachusetts (MA)
  • Michigan (MI)
  • Minnesota (MN)
  • Mississippi (MS)
  • Missouri (MO)
  • Montana (MT)
  • Nebraska (NE)
  • Nevada (NV)
  • New Hampshire (NH)
  • New Jersey (NJ)
  • New Mexico (NM)
  • New York (NY)
  • North Carolina (NC)
  • North Dakota (ND)
  • Ohio (OH)
  • Oklahoma (OK)
  • Oregon (OR)
  • Pennsylvania (PA)
  • Rhode Island (RI)
  • South Carolina (SC)
  • South Dakota (SD)
  • Tennessee (TN)
  • Texas (TX)
  • Utah (UT)
  • Vermont (VT)
  • Virginia (VA)
  • Washington (WA)
  • West Virginia (WV)
  • Wisconsin (WI)
  • Wyoming (WY)
  • Other (put in notes)

Facility

• Total pharmacy size (square feet)

• Non-sterile compounding room size (square feet)

• Non-sterile compounding powder hood quantity

• Non-sterile hazardous room size (square feet)

• Non-sterile hazardous powder hood quantity

• Are the hoods double hepa filtered or externally vented?

  Yes

  No

  N/A

• Sterile compounding Ante Room size (square feet)

• Sterile compounding clean/buffer room size (square feet)

• Sterile compounding LAFW quantity

• Sterile compounding BSC hood quantity

• Sterile compounding CAI/CACI (glovebox) hood quantity

• Negative pressure Sterile HD room size (square feet)

• Sterile HD BSC hood quantity

• Sterile HD CACI hood quantity

General Pharmacy Questions

• Is the PIC (or pharmacy manager/director) present for the inspection?

  Yes

  No

  N/A

• Is the PIC employed full time at the pharmacy?

  Yes

  No

  N/A

• Are there any other businesses located at this address?

  Yes

  No

  N/A

• Does the pharmacy have any other websites aside from their main one?

  Yes

  No

  N/A

• Does the pharmacy hold .pharmacy verification?

  Yes

  No

  N/A

• Do any other websites link to the pharmacy website (such as provider, or other affiliate)?

  Yes

  No

  N/A

• Does the pharmacy allow patients to securely enter/update profile and medical information through the website (such as through a secure patient portal)?

  Yes

  No

  N/A

• Are patients able to order or refill prescriptions through the website?

  Yes

  No

  N/A

• Are photographs allowed during the inspection (no PHI)?

  Yes

  No

  N/A

• Additional personnel interviewed as part of the inspection

• If the pharmacy mails or delivers filled prescriptions (patient specific, labeled with patient name when it leaves the pharmacy), are any of the deliveries to a provider or facility for administration to the patient?

  Yes

  No

  N/A

• Does the pharmacy provide prescription products to providers or facilities (including other pharmacies) as a wholesale distributer (sold to the provider or facility for their use, administration, or providing/dispensing to patients)?

  Yes

  No

  N/A

• Yes

  No

  N/A

• Is the percentage of product distributed at wholesale to providers or facilities within this state less than 5%?

  Yes

  No

  N/A

• Is the pharmacy operating under an exemption or restriction granted by the state in which the pharmacy is located or by any other state in which the pharmacy is licensed?

  Yes

  No

  N/A

• Is the pharmacy operating under a waiver or variance granted by the state in which the pharmacy is located or by any other state in which the pharmacy is licensed?

  Yes

  No

  N/A

• Does the pharmacy have any additional restrictions, limitations, or waivers with regards to any federal licenses or registrations (FDA, DEA, etc)?

  Yes

  No

  N/A

• Has the pharmacy been inspected or visited by the DEA?

  Yes

  No

  N/A

• Has the pharmacy been inspected by the FDA?

  Yes

  No

  N/A

• Does the pharmacy hold any accreditations or certifications?

  Yes

  No

  N/A

• Has the pharmacy held any accreditations or certifications in the past that they no longer hold?

  Yes

  No

  N/A

• Does the pharmacy perform patient lab testing such as blood glucose tests, cholesterol tests, etc? Verify that the lab director is current (usually the PIC is the lab director named).

  Yes

  No

  N/A

• Does the pharmacy maintain all required records, including but not limited to prescription files and invoices on site?

  Yes

  No

  N/A

• Are written and verbal prescriptions (reduced to writing) kept on site for the entire retention period?

  Yes

  No

  N/A

• Are electronic prescriptions (such as fax, e-scripts) kept on site for the entire retention period?

  Yes

  No

  N/A

• Are all dispensing records (such as refills, verifications, DUR overrides) kept on site for the entire retention period?

  Yes

  No

  N/A

• Are there systems in place to prevent a pharmacy record from being deleted after the prescription has been dispensed?

  Yes

  No

  N/A

• If records are stored off site are they secure in a HIPAA compliant manner and readily retrievable?

  Yes

  No

  N/A

• Is there a statement in the P&P, or are other means used to ensure that the most stringent laws/regulations are followed?

  Yes

  No

  N/A

Personnel

• Are all pharmacist, pharmacy intern, and pharmacy technician (if applicable) licenses or registrations with the board current and in good standing?

  Yes

  No

  N/A

• Is there a process for periodic verification of validity of licenses?

  Yes

  No

  N/A

• If pharmacists are providing patient services that require additional training or certification, are they appropriately trained and certified? (Immunization, CPR, MTM, etc.). Mark NA if no patient services that require additional training/certification.

  Yes

  No

  N/A

• Does the pharmacy maintain the proper technician-to-pharmacist ratio? Mark N/A if not required by resident state.

  Yes

  No

  N/A

Facility and Security

• Does the pharmacy have a working security/alarm system in place?

  Yes

  No

  N/A

• Are Schedule II controlled substances secured in a locked cabinet or safe?

  Yes

  No

  N/A

• Are there contingency plans in the event the pharmacy cannot be secured?

  Yes

  No

  N/A

• Is the pharmacy clean and sanitary, and is there appropriate space for the prescription volume? Look for clutter, or crowded counters or stacks of prescriptions to be checked.

  Yes

  No

  N/A

• Is the working area well lit and free of tripping hazards?

  Yes

  No

  N/A

• Is there a sink with hot and cold running water?

  Yes

  No

  N/A

• If the pharmacy destroys prescription products on site (such as expired, damaged, recalled, etc), do they appropriately document the destruction?

  Yes

  No

  N/A

• Does the pharmacy return prescription products to the manufacturer, distributor, or send to a reverse distributor for destruction?

  Yes

  No

  N/A

• Does the pharmacy have a hazardous waste handling and collection system? For example, empty bottles that contained chemotherapy medications or warfarin, or hazardous drug compounding waste.

  Yes

  No

  N/A

• Does the pharmacy have a private area for patient counseling and providing patient services?

  Yes

  No

  N/A

• Is temperature in the drug storage area maintained to provide controlled room temperature of 20° to 25°C (68° to 77 °F), or more restrictive if warranted by specific drug product storage requirements?

  Yes

  No

  N/A

• Is temperature monitoring in place to detect any excursions (24/7) by continuous monitoring or retroactive detection using min/max? Temperature records are maintained.

  Yes

  No

  N/A

• Are excursion action plans in place including evaluating excursion effects on drug product integrity?

  Yes

  No

  N/A

• Are the refrigerator and freezer restricted to drug products only (no food)?

  Yes

  No

  N/A

• Does the pharmacy have a process for how the refrigerator temperature is monitored for excursions 24/7?

  Yes

  No

  N/A

• Is the temperature in the refrigerator within the USP range (2°-8°C or 36°-46 °F) or as specified by FDA approved labeling for drug product storage?

  Yes

  No

  N/A

• Does the pharmacy have a process for how the freezer temperature is monitored for excursions 24/7?

  Yes

  No

  N/A

• Is the temperature in the freezer within the USP range (between −25° to −10°C or −13° to 14 °F) or as specified by FDA approved labeling for drug product storage?

  Yes

  No

  N/A

• Are there contingency plans in the event of power outage or refrigerator/freezer failure?

  Yes

  No

  N/A

• Are there contingency plans in the event of heating or air conditioning failure?

  Yes

  No

  N/A

• Is there a plan of action if there are any temperature or humidity excursions to determine if the integrity of the products has been compromised?

  Yes

  No

  N/A

• Does the pharmacy utilize any automated apparatuses for prescription processing/counting (such as robotics, Baker cells, etc)?

  Yes

  No

  N/A

• Do they have and follow policies and procedures addressing cross-contamination and identification of drug products?

  Yes

  No

  N/A

• Does the pharmacy have a documented process for establishing sources (vendors) of prescription drugs?

  Yes

  No

  N/A

• Does the pharmacy purchase all prescription drugs directly from the manufacturer?

  Yes

  No

  N/A

• Does the pharmacy purchase (obtain) prescription drugs from other pharmacies?

  Yes

  No

  N/A

• Does the pharmacy purchase (obtain) prescription drugs from wholesale distributors (non-manufacturer sources)?

  Yes

  No

  N/A

• Does the pharmacy purchase drugs from wholesale distributors that purchased the drug from other wholesale distributors?

  Yes

  No

  N/A

• Does the pharmacy have a process to handle suspect and illegitimate product investigations?

  Yes

  No

  N/A

• Has the pharmacy conducted any suspect or illegitimate product investigations?

  Yes

  No

  N/A

• Does the pharmacy have a procedure to verify product (suspect or illegitimate) including quarantine of product and reporting?

  Yes

  No

  N/A

• Does the pharmacy utilize paper DEA-222 forms to procure Schedule II substances?

  Yes

  No

  N/A

• Does the pharmacy utilize CSOS (electronic Schedule II ordering) to procure Schedule II substances?

  Yes

  No

  N/A

• Is the receipt of Schedule II orders documented appropriately? DEA-222 has the quantity and date on each line of product received, the CSOS record (electronic or paper printout) indicates verification of receipt and staff performing verification.

  Yes

  No

  N/A

• Are invoices for controlled substances (Schedules I-V) that are received filed separately and are the invoices signed/initialed and dated upon receipt and every item checked in?

  Yes

  No

  N/A

• Are all orders received when the pharmacy is open? Verify the orders are brought directly to the pharmacy still sealed and not delivered before the pharmacy is open.

  Yes

  No

  N/A

• Does the pharmacy purchase any compounded products from other entities for dispensing to patients?

  Yes

  No

  N/A

• Does the pharmacy have a system in place to track prescription drug products in order to detect diversion or theft?

  Yes

  No

  N/A

• Are incidents of diversion or resignation/termination of personnel for cause reported?

  Yes

  No

  N/A

• Does the pharmacy keep a perpetual inventory log of all Schedule II controlled substances (including APIs, if applicable)?

  Yes

  No

  N/A

• Is the Schedule II perpetual inventory log reconciled regularly?

  Yes

  No

  N/A

• Is the most recent complete controlled substances inventory available for review?

  Yes

  No

  N/A

• Does the pharmacy maintain other required inventories (such as change in PIC, theft/loss, etc)?

  Yes

  No

  N/A

• Does the pharmacy stock and sell OTC pseudoephedrine (and/or ephedrine) products? If yes, indicate if the sale is recorded electronically or manually in a logbook.

  Yes

  No

  N/A

• Are these products mailed, sent, or delivered into other states? View logs.

  Yes

  No

  N/A

• Are outdated, damaged, or recalled products segregated?

  Yes

  No

  N/A

• How often does the pharmacy check for out-of-date products?

• Are all drugs within active-stock within expiration date?

  Yes

  No

  N/A

• How often is active-stock examined for drugs past the expiration date?

• Does the pharmacy prepackage bulk containers of prescription medications into smaller containers for ease of use?

  Yes

  No

  N/A

• What BUD is used on the prepackaged container?

• Is the date of transfer, manufacturer, lot number, amount transferred, person performing transfer, and RPh verifying on the label?

  Yes

  No

  N/A

• Does the pharmacy return to stock prescription drugs that were filled but never picked up?

  Yes

  No

  N/A

• Are they maintained in the appropriate container, with PHI removed and BUD adjusted?

  Yes

  No

  N/A

USP 795

• Designated Person(s): The compounding facility must designate one or more individuals to be responsible for the operation of the facility and personnel for the preparation of CSNPs. The designated person(s) must be identified in an SOP. If the compounding facility has only one person responsible for all compounding in the facility, then that person is the designated person. Has a designated person(s) been formally assigned?

  Compliant

  Non-Compliant

  N/A

• Personnel Training and Evaluation: All personnel who compound or have direct oversight of compounding CNSPs must be initially trained and qualified by demonstrating knowledge and competency before being allowed to perform their job functions independently. Has initial training been performed and documented?

  Compliant

  Non-Compliant

  N/A

• Has training been completed every 12 months?

  Compliant

  Non-Compliant

  N/A

• Personnel who do not compound and only perform functions such as in-process checks, final verification, or dispensing CNSPs, must undergo training. Have they been trained as well?

  Compliant

  Non-Compliant

  N/A

• Knowledge and competency must be demonstrated initially and at least every 12 months in at least the following core competencies: * Hand hygiene * Garbing * Cleaning and sanitizing * Handling and transporting components and CNSPs * Measuring and mixing * Proper use of equipment and devices selected to compound CNSPs * Documentation of the compounding process

  Compliant

  Non-Compliant

  N/A

• Steps in the training procedure must include the following: * Understand the requirements in USP <795> * Understand and interpret safety data sheets (SDSs) and certificates of analysis (COA) * Read and understand procedures related to their compounding duties

  Compliant

  Non-Compliant

  N/A

• Training and observation may be performed by the designated person(s) or an assigned trainer. Personnel must be observed and guided throughout the training process. The personnel will then be expected to repeat the procedures independently while under the direct supervision of the designated person(s) and/or assigned trainer. Personnel will be permitted to perform the procedure without direct supervision only after independently demonstrating understanding and competency. Upon completion of the training program, the designated person(s) and/or assigned trainer must document that personnel have been trained and successfully completed competency assessments.

  Compliant

  Non-Compliant

  N/A

• In addition to the initial and annual competency training and evaluation described in this section, the designated person(s) will monitor and observe compounding activities and must take immediate corrective action if deficient practices are observed.

  Compliant

  Non-Compliant

  N/A

• To minimize the chance for cross-contaminating other CNSPs and contaminating other objects (e.g. pens and keyboards), gloves should be wiped or replaced before beginning a CNSP that has different components.

  Compliant

  Non-Compliant

  N/A

• Pharmacy uses SDS to determine other garb requirements for the components and compounding activity.

  Compliant

  Non-Compliant

  N/A

• Additional garb (shoe covers, hair and facial hair covers, face masks, gowns) is worn as needed for protection of the personnel/CNSPs.

  Compliant

  Non-Compliant

  N/A

• The garb purchased by the pharmacy is appropriate for the type of compounding being performed.

  Compliant

  Non-Compliant

  N/A

• Garb is stored in manner that minimizes risk of contamination (away from sinks to avoid splashing, etc).

  Compliant

  Non-Compliant

  N/A

• Gowns that are reused do not leave the compounding area.

  Compliant

  Non-Compliant

  N/A

• Visibly soiled garb or garb with tears or punctures are changed immediately (are not reused).

  Compliant

  Non-Compliant

  N/A

• Soiled garb is disposed of or sent for laundering.

  Compliant

  Non-Compliant

  N/A

• Shoe covers, hair and facial hair covers, face masks, and head covers are not reused once personnel have left the compounding area.

  Compliant

  Non-Compliant

  N/A

• Are non-disposable garb such as goggles cleaned then sanitized with 70% isopropyl alcohol before re-use?

  Compliant

  Non-Compliant

  N/A

USP 795 Buildings and Facilities

• Does the compounding area meet the facility requirements in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a designated compounding space for nonsterile compounding.

  Compliant

  Non-Compliant

  N/A

• The compounding area is well lit.

  Compliant

  Non-Compliant

  N/A

• The compounding area is clean and sanitary.

  Compliant

  Non-Compliant

  N/A

• The compounding area is orderly (eg, clutter free, no tripping hazards).

  Compliant

  Non-Compliant

  N/A

• The compounding area is in a good state of repair.

  Compliant

  Non-Compliant

  N/A

• The compounding area is designed for orderly placement of equipment and materials to prevent mix- ups among components, containers, labels, in-process materials, and finished CNSPs.

  Compliant

  Non-Compliant

  N/A

• The compounding area is not being used for other activities at the same time that it is used for compounding.

  Compliant

  Non-Compliant

  N/A

• The compounding area is designed, arranged, and used in a manner that minimizes cross contamination from non-compounding areas.

  Compliant

  Non-Compliant

  N/A

• Is the compounding area free of carpet?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy's storage area (for CNSPs, components, equipment, and containers) meet requirements in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The pharmacy records the temperature of the compounding storage area on days when the pharmacy is open.

  Compliant

  Non-Compliant

  N/A

• The pharmacy's temperature monitoring records are readily retrievable.

  Compliant

  Non-Compliant

  N/A

• Temperature monitoring devices are verified for accuracy at least every 12 months or as required by the manufacturer.

  Compliant

  Non-Compliant

  N/A

• Pharmacy has a process to evaluate temperature excursions.

  Compliant

  Non-Compliant

  N/A

• CNSPs, components, equipment, and containers are stored off the floor.

  Compliant

  Non-Compliant

  N/A

• CNSPs, components, equipment, and containers are stored in a manner that permits inspection and cleaning of the storage area(s).

  Compliant

  Non-Compliant

  N/A

• CNSPs, components, equipment, and containers are stored in a clean environment (free of dirt, dust, and debris, and rodent/pest/insect free) to prevent contamination.

  Compliant

  Non-Compliant

  N/A

• What is the current temperature of the nonsterile compounding storage area?

  Compliant

  Non-Compliant

  N/A

• Are plumbing fixtures, water sources, and cleanliness of sink in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The pharmacy staff can easily access a sink within or nearby the nonsterile compounding area.

  Compliant

  Non-Compliant

  N/A

• There is hot and cold running water available at the sink within or nearby the nonsterile compounding area.

  Compliant

  Non-Compliant

  N/A

• The sink is emptied of all items unrelated to compounding and before being used to clean any equipment used in nonsterile compounding.

  Compliant

  Non-Compliant

  N/A

• The sink is cleaned when visibly soiled (before being used to clean equipment used in nonsterile compounding).

  Compliant

  Non-Compliant

  N/A

• The plumbing system is free of any defects that may contribute to contamination of CNSPs.

  Compliant

  Non-Compliant

  N/A

• Is purified water, distilled water, or reverse osmosis water used for rinsing equipment and utensils used in nonsterile compounding?

  Compliant

  Non-Compliant

  N/A

• What agent(s) are used for cleaning and sanitizing the nonsterile compounding area?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy perform cleaning and sanitizing activities on all surfaces at the minimum frequency per Table 1 and documented in a log or other record in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• All work surfaces are cleaned and sanitized at the beginning of each shift on days when compounding occurs.

  Compliant

  Non-Compliant

  N/A

• All work surfaces are cleaned and sanitized at the end of each shift on days when compounding occurs.

  Compliant

  Non-Compliant

  N/A

• All work surfaces are cleaned and sanitized between compounding CNSPs with different components.

  Compliant

  Non-Compliant

  N/A

• Floors are cleaned and sanitized daily on days when compounding occurs.

  Compliant

  Non-Compliant

  N/A

• Walls and ceilings are cleaned and sanitized when visibly soiled.

  Compliant

  Non-Compliant

  N/A

• All work surfaces, floors, walls, ceilings and storage shelving are cleaned and sanitized when surface contamination (eg, splashes) or spills are known or suspected.

  Compliant

  Non-Compliant

  N/A

• Storage shelving is cleaned and sanitized at least every three months.

  Compliant

  Non-Compliant

  N/A

• Are floors in the compounding area easily cleanable, non-porous, and non-particle generating?

  Compliant

  Non-Compliant

  N/A

USP 795 Equipment and Components

• Does the pharmacy use a closed-system processing device (eg, CVE, BSC, and single-use containment glove bags)?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy select, store, clean, and maintain equipment in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Equipment and supplies are readily available at the pharmacy for the types of CNSPs prepared.

  Compliant

  Non-Compliant

  N/A

• Pharmacy has evaluated and documented the nonsterile compounding pharmacy activities for weighing, measuring, and otherwise manipulating for an assessment of risk.

  Compliant

  Non-Compliant

  N/A

• The equipment and devices used for compounding CNSPs are clean and stored in a manner and frequency that minimizes the risk of contamination.

  Compliant

  Non-Compliant

  N/A

• Equipment and devices used in compounding or testing of CNSPs are inspected prior to use (to ensure they are in good working order).

  Compliant

  Non-Compliant

  N/A

• Equipment and devices are verified for accuracy as recommended by the manufacturer (at the frequency recommended by the manufacturer or at least every 12 months, whichever is more frequent).

  Compliant

  Non-Compliant

  N/A

• If a CVE or BSC is used by the pharmacy, it is certified at least every 12 months, according to the manufacturer specifications or regulations of the applicable regulatory jurisdiction.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy compounding CNSPs use APIs?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy select APIs that comply with the requirements in USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• APIs comply with criteria in the USP-NF monograph, if one exists.

  Compliant

  Non-Compliant

  N/A

• All APIs used have a COA that includes the specifications (eg, compendial requirements for quality) and that the test results for the component show the API meets expected quality.

  Compliant

  Non-Compliant

  N/A

• All APIs used are manufactured by an FDA-registered facility.

  Compliant

  Non-Compliant

  N/A

• When formulations indicate the inclusion of water, is purified water or better quality (eg, sterile water for irrigation) used in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• What type(s) of water is used for compounding CNSP?

  Compliant

  Non-Compliant

  N/A

• Do the pharmacy's component receipt processes comply with the requirements in USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• For non-conventionally manufactured components, the COA is reviewed upon receipt.

  Compliant

  Non-Compliant

  N/A

• The pharmacy documents specific information according to the facility's SOP, including: receipt date, quantity received, supplier name, lot number, expiration date, and the results of any testing performed (whether performed in-house or through a third-party).

  Compliant

  Non-Compliant

  N/A

• For all components that lack a vendor expiration date, the pharmacy clearly and indelibly marks on each packaging system received the date the component must no longer be used by the pharmacy.

  Compliant

  Non-Compliant

  N/A

• Any component found to be of unacceptable quality upon receipt or reinspection prior to use is promptly rejected, clearly labeled as rejected, and segregated from active stock to prevent use before appropriate disposal.

  Compliant

  Non-Compliant

  N/A

• Any other lots of that (rejected) component from that vendor are examined to determine whether other lots have the same defect.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy re-inspect all components before use and handle them in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Compounding personnel visually re-inspect each component, including packaging system (any evidence of container breakage, looseness of cap or closure) and deviation from the expected appearance or texture of the contents (that might have changed during storage).

  Compliant

  Non-Compliant

  N/A

• Compounding personnel ascertain before use that components are the correct identity based on labeling, that they have been stored under required conditions, and there is no evidence of deterioration or other aspects of unacceptable quality before use of component.

  Compliant

  Non-Compliant

  N/A

• Components where correct identity, strength, purity, and quality cannot be confirmed (eg, containers with damaged or incomplete labeling), are immediately rejected and if not immediately discarded, labeled as rejected and segregated from active stock.

  Compliant

  Non-Compliant

  N/A

• Compounding personnel handle all components following facility SOPs, manufacturer's instructions/labeling, and laws/regulations of the applicable regulatory jurisdiction.

  Compliant

  Non-Compliant

  N/A

• All components are handled in a manner that minimizes the risk of contamination, mix-ups, and deterioration.

  Compliant

  Non-Compliant

  N/A

• When components are removed from the original container and not used in compounding (eg, excess after weighing), are they discarded and not returned to the original container (to minimize risk of contamination of the original component container)?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy maintain a chemical hazard, spill management, and disposal information program in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff have access to safety data sheets (SDS).

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff have documented, annual training for those who might have to clean up a spill.

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a readily accessible spill kit in the compounding area.

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a process to manage and document any nonhazardous spills and disposal.

  Compliant

  Non-Compliant

  N/A

• Waste of any component is disposed of in accordance with laws and regulations of the applicable regulatory jurisdiction.

  Compliant

  Non-Compliant

  N/A

Master Formulation Records (MFR) and Compounding Records (CR) - Inspector to review a minimum 5 MFRs and 5 CRs

• Is an MFR created for each unique formulation of a CNSP in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• An MFR is created for each unique formulation.

  Compliant

  Non-Compliant

  N/A

• Any changes or alterations to the MFR are approved and documented.

  Compliant

  Non-Compliant

  N/A

• Does the designated person(s) or designee evaluate CNSP's characteristics when considering the assigned BUD for an MFR?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy's MFRs contain all requirements in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• MFR includes the name, strength or activity, and dosage form of the CNSP.

  Compliant

  Non-Compliant

  N/A

• MFR identifies the identities and amounts of all components and, if applicable, relevant characteristics of components (eg, particle size, salt form, purity grade, solubility).

  Compliant

  Non-Compliant

  N/A

• MFR includes the type of container–closure system(s).

  Compliant

  Non-Compliant

  N/A

• MFR has complete instructions for preparing the CNSP, including equipment, supplies, and a description of the compounding steps.

  Compliant

  Non-Compliant

  N/A

• MFR has a physical description of the final CNSP.

  Compliant

  Non-Compliant

  N/A

• MFR includes the assigned beyond-use date (BUD) and storage requirements.

  Compliant

  Non-Compliant

  N/A

• MFR contains the reference source to support the assigned BUD.

  Compliant

  Non-Compliant

  N/A

• Labeling requirements (eg, shake well) are described on the MFR.

  Compliant

  Non-Compliant

  N/A

• If applicable, the MFR contains the calculations to determine and verify quantities and/or concentrations of components and strength or activity of APIs.

  Compliant

  Non-Compliant

  N/A

• An MFR has QC procedures (eg, pH testing, visual inspection) and expected results.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy complete a Compounding Record (CR) for all CNSPs in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• A CR is completed for each CNSP prepared.

  Compliant

  Non-Compliant

  N/A

• The CR includes the name, strength or activity, and dosage form of the CNSP.

  Compliant

  Non-Compliant

  N/A

• The CR includes the date (or date and time) the CNSP was prepared.

  Compliant

  Non-Compliant

  N/A

• The CR includes the assigned internal identification number (eg, prescription, order, or lot number).

  Compliant

  Non-Compliant

  N/A

• The CR has a method to identify the individuals involved in the compounding process of the CNSP.

  Compliant

  Non-Compliant

  N/A

• The CR has a method to identify the individual who completed the review and verified the final CNSP.

  Compliant

  Non-Compliant

  N/A

• The CR includes: name, vendor or manufacturer, lot number, and expiration date of each component.

  Compliant

  Non-Compliant

  N/A

• The CR includes the weight or measurement of each component.

  Compliant

  Non-Compliant

  N/A

• The CR identifies the total quantity compounded.

  Compliant

  Non-Compliant

  N/A

• The CR lists the assigned BUD and storage requirements.

  Compliant

  Non-Compliant

  N/A

• If applicable, the CR contains the calculations to determine and verify quantities and/or concentrations of components and strength or activity of API.

  Compliant

  Non-Compliant

  N/A

• The CR has a physical description of the final CNSP.

  Compliant

  Non-Compliant

  N/A

• The CR includes the results of quality control procedures (eg, pH testing, visual inspection).

  Compliant

  Non-Compliant

  N/A

• The CR contains a MFR reference for the CNSP.

  Compliant

  Non-Compliant

  N/A

• Each CR is reviewed for completeness before the CNSP is released.

  Compliant

  Non-Compliant

  N/A

• The CR shows traceability of all components in the case of a recall or known quality issue.

  Compliant

  Non-Compliant

  N/A

• Are there procedures for in-process checks performed by a pharmacist?

  Compliant

  Non-Compliant

  N/A

• Are the pharmacy's labels for CNSPs in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Information on the label is prominently and legibly displayed.

  Compliant

  Non-Compliant

  N/A

• The labeling meets any state or federal regulatory requirements.

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes an assigned internal identification number (eg, barcode, prescription, order, or lot number).

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes the active ingredients and their amount(s), activity(ies), or concentration(s).

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes the storage conditions, if other than controlled room temperature.

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes the BUD.

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes the dosage form.

  Compliant

  Non-Compliant

  N/A

• The label on the immediate container includes the total amount or volume, if it is not obvious from the container.

  Compliant

  Non-Compliant

  N/A

• Does the labeling on the dispensed CNSP include the route of administration?

  Compliant

  Non-Compliant

  N/A

• Does the labeling contain information identifying the CNSP as a compounded preparation?

  Compliant

  Non-Compliant

  N/A

• Does the labeling on the dispensed CNSP display any applicable special handling instructions or warning statements?

  Compliant

  Non-Compliant

  N/A

• Does the labeling on the dispensed CNSP display the name of the compounding facility and contact information if the CNSP was to be sent outside of the facility or health care system?

  Compliant

  Non-Compliant

  N/A

• Is each CNSP assigned and labeled with a BUD in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• CNSP label has a BUD that specifies the date, or the hour and date, beyond which the preparation cannot be used and must be discarded.

  Compliant

  Non-Compliant

  N/A

• CNSP labels do not list an "expiration date" or equivalent language.

  Compliant

  Non-Compliant

  N/A

• BUDs are assigned from the date (and time) of preparation.

  Compliant

  Non-Compliant

  N/A

• BUDs are assigned based on dispensing in tight, light resistant containers/overpacks.

  Compliant

  Non-Compliant

  N/A

• The BUD assigned to the CNSP does not exceed the shortest remaining expiration date of any of the commercially available starting components.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy ensure the assigned BUD does not exceed the shortest BUD of any individual compounded components?

  Compliant

  Non-Compliant

  N/A

• Does the designated person(s) evaluate a CNSP formulation to establish the maximum BUD?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy compound CNSPs with a USP monograph?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy compound CNSPs following the USP monograph precisely?

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff have access to the USP monograph for reference.

  Compliant

  Non-Compliant

  N/A

• CNSPs are prepared in accordance with the USP monographs.

  Compliant

  Non-Compliant

  N/A

• Components used by the compounder match those listed in the monograph.

  Compliant

  Non-Compliant

  N/A

• The maximum BUD specified in the USP monograph is not exceeded.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy compound CNSPs that are not available from a USP monograph?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy adhere to the BUD (maximum) limits established in Table 4 for CNSPs in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Non-preserved, Aqueous Dosage Forms: The non-preserved, aqueous dosage form CNSP is labeled with a BUD that does not exceed 14 days with refrigerated storage temperature.

  Compliant

  Non-Compliant

  N/A

• Preserved, Aqueous Dosage Forms: The preserved, aqueous dosage form CNSP is labeled with a BUD that does not exceed 35 days with controlled room temperature or refrigerated storage temperature.

  Compliant

  Non-Compliant

  N/A

• Nonaqueous, Oral Liquid Dosage Forms: The nonaqueous, oral liquid dosage form CNSP is labeled with a BUD that does not exceed 90 days with controlled room temperature or refrigerated storage temperature.

  Compliant

  Non-Compliant

  N/A

• Nonaqueous Dosage Forms: The nonaqueous dosage form CNSP is labeled with a BUD that does not exceed 180 days with controlled room temperature or refrigerated storage temperature.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy label any CNSPs with BUDs that extend beyond the maximum limits in Table 4 USP <795>?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy follow the requirements for labeling a CNSP with a BUD that exceeds Table 4 in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The labeled BUD for an aqueous dosage form does not exceed 180 days.

  Compliant

  Non-Compliant

  N/A

• The labeled BUD for a nonaqueous dosage form does not exceed 180 days

  Compliant

  Non-Compliant

  N/A

• Pharmacy is following the results of their own stability study.

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a copy of the cited stability study, which used a stability-indicating analytical method, for extending BUDs.

  Compliant

  Non-Compliant

  N/A

• The cited stability study (which uses a stability-indicating analytical method for extending BUDs) describes the API(s), CNSP formulation, and material composition of the container closure used.

  Compliant

  Non-Compliant

  N/A

• If the cited stability study (which uses a stability-indicating analytical method for extending BUDs) is bracketed, the pharmacy's CNSP formulation is at or within the low and high concentration of each active ingredient within the stability study.

  Compliant

  Non-Compliant

  N/A

• Aqueous CNSPs whose labeled BUDs are extended beyond Table 4, have: - been tested for antimicrobial effectiveness at least once for each formulation in the type of (with the same material composition of the) container closure system that will be used;- received study results from an FDA-registered facility (for the same CNSP formulation using the same material composition of the container closure system); or- a study published from peer-reviewed literature (for the same CNSP formulation using the same material composition of the container closure system).

  Compliant

  Non-Compliant

  N/A

Quality Assurance (QA), Quality Control (QC), and Quality Management (QM) - Inspector to review at least one complaint, one adverse event, and one recall (if applicable)

• Does the pharmacy have a QA/QC program to ensure that CNSPs are prepared per the requirements in USP <795> standards and any applicable regulatory requirements?

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a formal QA/QC program with documented activities.

  Compliant

  Non-Compliant

  N/A

• The QA/QC programs address adherence to procedures.

  Compliant

  Non-Compliant

  N/A

• The QA/QC programs address prevention and detection of errors and other quality problems.

  Compliant

  Non-Compliant

  N/A

• The QA/QC programs address evaluation of complaints and adverse events.

  Compliant

  Non-Compliant

  N/A

• The QA/QC programs address appropriate investigations and corrective actions.

  Compliant

  Non-Compliant

  N/A

• Has the pharmacy received any complaints related to CNSPs within the past year?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy follow complaint handling requirements in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The pharmacy has a complete written or electronic record of each complaint made.

  Compliant

  Non-Compliant

  N/A

• Complaints are reviewed in accordance with SOPs by the designated person for the QA program.

  Compliant

  Non-Compliant

  N/A

• Complaints are reviewed to determine whether it indicates a potential quality problem with the CNSP.

  Compliant

  Non-Compliant

  N/A

• Complaints are fully investigated.

  Compliant

  Non-Compliant

  N/A

• Complaint investigations consider whether the quality problem extends to other CNSPs.

  Compliant

  Non-Compliant

  N/A

• Corrective action, if necessary, is implemented for all potentially affected CNSPs.

  Compliant

  Non-Compliant

  N/A

• A CNSP that is returned in connection with a complaint is quarantined until it is destroyed after the completion of the investigation and in accordance with the laws and regulations of the applicable regulatory jurisdiction.

  Compliant

  Non-Compliant

  N/A

• Has the pharmacy initiated any recalls of CNSPs within the past two years?

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy follow recall and adverse event procedures for CNSPs in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The pharmacy has procedures to determine when recalls must be initiated.

  Compliant

  Non-Compliant

  N/A

• The pharmacy documented the implementation of the recall.

  Compliant

  Non-Compliant

  N/A

• Pharmacy reports recalled CNSPs to the appropriate regulatory bodies (as required by laws and regulations of the applicable regulatory jurisdiction).

  Compliant

  Non-Compliant

  N/A

• Investigations into an adverse event that reveals a quality problem with a CNSP that is likely to affect other patients are reported to both patients and their prescribers.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy procedures include a step to immediately notify the prescriber of a failure of specifications with potential to cause harm (eg, strength, purity, or other quality attributes)?

  Compliant

  Non-Compliant

  N/A

USP 795 - CNSP Packaging

• Does the pharmacy's packaging processes and materials meet the requirements in USP <795>?

  Compliant

  Non-Compliant

  N/A

• The packaging materials protect CNSPs from damage, leakage, contamination, and degradation.

  Compliant

  Non-Compliant

  N/A

• The packaging materials used protects personnel from exposure (from the packaged CNSP).

  Compliant

  Non-Compliant

  N/A

• The packaging materials selected by the pharmacy maintain the physical and chemical integrity and stability needed for CNSPs (eg, protect from light).

  Compliant

  Non-Compliant

  N/A

USP 795 Compounding Personnel Observations - Inspector must observe personnel performing compounding and related activities. This section will require the inspector to observe the staff while performing compounding and related activities. It is acceptable for pharmacy staff to perform mock compounding activities (with two creams or other drugs) as long as all observations can be viewed.

• Personal Preparation Observation: Before entering the compounding area, do personnel remove any items that are not easily cleanable or are not necessary for compounding in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Personnel removed all outer garments (eg, hats, scarves, bandanas, vests, coats, and jackets).

  Compliant

  Non-Compliant

  N/A

• Personnel removed all items that are not easily cleanable and that might interfere with garbing.

  Compliant

  Non-Compliant

  N/A

• Personnel removed all hand, wrist, and other exposed jewelry, including piercings, that could interfere with the effectiveness of garbing and hand hygiene (eg, watches, rings that may tear gloves).

  Compliant

  Non-Compliant

  N/A

• Personnel removed earbuds or headphones.

  Compliant

  Non-Compliant

  N/A

• Any accommodations permitted by the designated person(s) should be documented.

  Compliant

  Non-Compliant

  N/A

• Hand Hygiene Observation: Were personnel who enter the compounding area to compound observed performing the appropriate hand washing procedures in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• All personnel who enter the compounding area to compound performed hand hygiene.

  Compliant

  Non-Compliant

  N/A

• Personnel wash hands with soap and water for at least 30 seconds.

  Compliant

  Non-Compliant

  N/A

• Personnel dry their hands completely with disposable towels or wipers.

  Compliant

  Non-Compliant

  N/A

• Garbing Observation: Were compounding personnel observed following the appropriate garbing procedures in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• All personnel entering the compounding area are fully garbed (with the required garb as determined by the facility SOPs).

  Compliant

  Non-Compliant

  N/A

• All personnel who perform compounding activities don gloves.

  Compliant

  Non-Compliant

  N/A

• Gloves are inspected periodically for holes, punctures, or tears and replaced immediately if a defect is detected.

  Compliant

  Non-Compliant

  N/A

• Are gloves wiped or replaced before beginning compounding a CNSP with a different component or when other objects were touched (eg, pens, keyboards) to minimize risk of cross contamination with other CNSPs?

  Compliant

  Non-Compliant

  N/A

• List the name(s) of the CNSPs observed by the inspector as part of live compounding demonstration.

  Compliant

  Non-Compliant

  N/A

• Compounding Observation: Are compounding personnel using appropriate nonsterile compounding techniques for CNSPs in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• The compounding personnel enter the nonsterile compounding area in accordance with the SOPs.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel started with a clean compounding area for CNSPs.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel selected the correct MFR for the CNSP to be prepared.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel performed hand hygiene.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel are appropriately garbed for the type of CNSP prepared.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel obtained the proper ingredients (APIs and/or components).

  Compliant

  Non-Compliant

  N/A

• The compounding personnel gathered all necessary materials, equipment, and supplies necessary and/or specified in the MFR and is in good working order prior to use for the CNSP.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel have knowledge of and access to any SDS.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel only compound one CNSP at a time (to proactively prevent mix-ups, errors, and cross contamination).

  Compliant

  Non-Compliant

  N/A

• The compounding personnel compound the CNSP according to the MFR.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel document any required steps listed in the MFR on the CR.

  Compliant

  Non-Compliant

  N/A

• Documentation in the CR is legible.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel verify the correct BUD in accordance with the MFR requirements in USP <795>.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel performed any quality control steps specified in the MFR.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel placed the CNSP into the proper container closure system.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel labeled the CNSP.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel completed any documentation on the CR.

  Compliant

  Non-Compliant

  N/A

• The compounding personnel cleaned and sanitized the compounding area before the next CNSP (with differing ingredients) is prepared.

  Compliant

  Non-Compliant

  N/A

• Final CNSP check observation: Does the visual inspection of the CNSP by the pharmacist confirm all USP <795> requirements?

  Compliant

  Non-Compliant

  N/A

• CNSP was visually inspected to determine the physical appearance of the CNSP is as expected (eg, color, texture, physical uniformity), including any special characteristics listed in the MFR (eg, emulsions must be checked for phase separation).

  Compliant

  Non-Compliant

  N/A

• Visual inspection included checking for container closure integrity (eg, leakage, cracks, improper seals).

  Compliant

  Non-Compliant

  N/A

• CNSP label was verified against the prescription or medication order.

  Compliant

  Non-Compliant

  N/A

• CNSP label was verified against the MFR.

  Compliant

  Non-Compliant

  N/A

• CNSP label was verified against the CR.

  Compliant

  Non-Compliant

  N/A

• If a CNSP will not be released or dispensed on the day the preparation was made, a visual inspection was conducted immediately before it is released or dispensed to make sure the CNSP did not develop any defects during storage.

  Compliant

  Non-Compliant

  N/A

• All checks and inspection that are performed are properly documented.

  Compliant

  Non-Compliant

  N/A

• CNSP that do not meet requirements, are promptly rejected, clearly labeled as rejected, and segregated from active stock to prevent use before disposal

  Compliant

  Non-Compliant

  N/A

• Inspect several different finished compounded nonsterile preparations. Are all the finished compounded preparations free from any evidence of signs of contamination?

  Compliant

  Non-Compliant

  N/A

• Cleaning and Disinfection Observation: Does the pharmacy perform cleaning and sanitizing activities in the compounding area in compliance with USP <795> standards?

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff starts with a clean and sanitized work surface prior to compounding a CNSP.

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff perform cleaning and sanitizing between compounding CNSPs with different components.

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff ensure equipment and devices used in compounding activities are clean and sanitized after use (to prevent cross contamination of the next preparation).

  Compliant

  Non-Compliant

  N/A

• Pharmacy staff perform cleaning and sanitizing on work surfaces when visibly soiled, after spills, and/or when surface contamination is known or suspected.

  Compliant

  Non-Compliant

  N/A

USP 795 Employee File Records Review - Review each for proof of review and employee sign off for initial training and annually thereafter.

• Compounding personnel are trained on facility SOPs.

  Compliant

  Non-Compliant

  N/A

• Compounding personnel are trained on USP <795> standards.

  Compliant

  Non-Compliant

  N/A

• The training record for hand hygiene is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for garbing is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for cleaning and sanitizing is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for handling and transporting components and CNSPs is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for measuring and mixing is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for proper use of equipment is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for documentation of compounding processes (eg, Master Formulation Records or Compounding Records) is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for interpreting a Certification of Analysis (COA) is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for how to read/interpret a Safety Data Sheet (SDS) is complete.

  Compliant

  Non-Compliant

  N/A

• The training record for spill management is complete.

  Compliant

  Non-Compliant

  N/A

• The designated person(s) has documented a (periodic) evaluation of their direct observations for compounding activities and documented any deficiencies in the record.

  Compliant

  Non-Compliant

  N/A

• Does the pharmacy handle any drugs on the National Institute for Occupational Safety and Health (NIOSH) list that require all the containment requirements of USP <800>?

  Yes

  No

  N/A

• Does the pharmacy handle any hazardous drug active pharmaceutical ingredients (HD API)? If yes, list in notes

  Yes

  No

  N/A

• Does the pharmacy handle any antineoplastic requiring manipulations (which can produce particles, aerosols, or gasses)? If yes, list.

  Yes

  No

  N/A

• Does the pharmacy handle any drugs on the NIOSH list that do not require all containment requirements of <800>?

  Yes

  No

  N/A

• Does the pharmacy handle any final dosage forms of HDs (either compounded or manufactured unless required by the manufacturer) that do not require further manipulation other than counting and repackaging? If yes, please list.

  Yes

  No

  N/A

• Does the pharmacy handle any dosage forms of other HDs that are handled in full compliance with containment requirements of <800>? If yes, please list.

  Yes

  No

  N/A

• Does the pharmacy handle any dosage forms of other HDs that are not handled using all containment requirements of <800>? If yes, please list.

  Yes

  No

  N/A

List of Hazardous Drugs

• The pharmacy maintains a list of any items it handles that are included on the current NIOSH list of antineoplastic and other HDs. Review and attach list. Verify that pharmacy has access to a copy of current NIOSH list.

  Yes

  No

  N/A

• The pharmacy reviews this list at least every 12 months for additions, deletions, or other changes and documents the review. Verify documentation and list date of last change/review.

  Yes

  No

  N/A

• The pharmacy reviews this list whenever the pharmacy adds a new agent or dosage form to the items it handles.

  Yes

  No

  N/A

• The pharmacy has a system in place for the evaluation of new drugs (purchased, stored, handled, and/or dispensed) to determine whether they are considered HD.

  Yes

  No

  N/A

• Pharmacy evaluates the drugs against the current version of the NIOSH list.

  Yes

  No

  N/A

• In the absence of information, the pharmacy treats any new drug as an HD.

  Yes

  No

  N/A

• If the pharmacy handles any HDs not using all containment requirements of <800>, an assessment of risk was performed for each drug and dosage form individually to determine alternative containment strategies, if needed, and work practices for each.

  Yes

  No

  N/A

• The assessment of risk evaluation performed by the pharmacy’s organization includes all required information, for each drug and dosage form.

  Yes

  No

  N/A

• Assessment of risk performed for Type of HD (eg, antineoplastic, non-antineoplastic, reproductive risk only)

  Yes

  No

  N/A

• Assessment of risk performed for Dosage form

  Yes

  No

  N/A

• Assessment of risk performed for Risk of exposure

  Yes

  No

  N/A

• Assessment of risk performed for Packaging

  Yes

  No

  N/A

• Assessment of risk performed for Manipulation

  Yes

  No

  N/A

• Assessment of risk performed for (if applicable) Table II and III drugs have alternative containment strategies and/or work practices to minimize occupational exposure.

  Yes

  No

  N/A

• The assessment of risk is reviewed at least every 12 months, and the review is documented.

  Yes

  No

  N/A

USP 800 Personnel Responsibilities

• The pharmacy has a designated person(s) to oversee the handling of HDs who is qualified and trained for development of standard operating procedures (SOPs); overseeing compliance with standards, laws, and rules; ensuring competency of personnel; and ensuring environmental control.

  Yes

  No

  N/A

• The designated person oversees the monitoring of the facility, including testing/sampling programs, maintaining, and documentation, and acting on results.

  Yes

  No

  N/A

USP 800 Documentation and SOPs

• Receiving: Contacting HD residues on packaging, work surfaces, floors

  Yes

  No

  N/A

• Dispensing: Counting or packaging tablets and capsules

  Yes

  No

  N/A

• Compounding/other manipulations: Crushing/splitting tablets, opening capsules, pouring liquids, weighing or mixing, constituting/reconstituting powdered/lyophilized HDs, expelling air from HD syringes, HD residue on personal protective equipment (PPE), cleaning activities of HD areas, and HD equipment maintenance.

  Yes

  No

  N/A

• Administration and other patient care activities (if applicable).

  Yes

  No

  N/A

• Spills: Spill generation, management, and disposal.

  Yes

  No

  N/A

• Transport

  Yes

  No

  N/A

• Waste: Collection and disposal of HD waste and trace contaminated waste

  Yes

  No

  N/A

• SOPs are reviewed at least every 12 months by the designated person, and the review is documented.

  Yes

  No

  N/A

• SOPs are readily available to all who may need to handle HD or respond to a spill (pharmacy employees, housekeeping, nursing personnel, delivery personnel, etc).

  Yes

  No

  N/A

• Hazard communication program plan

  Yes

  No

  N/A

• Competent personnel

  Yes

  No

  N/A

• Occupational safety program

  Yes

  No

  N/A

• Designation of HD areas

  Yes

  No

  N/A

• Receiving HDs, including handling of damaged shipping containers/breakages

  Yes

  No

  N/A

• A list of HDs

  Yes

  No

  N/A

• Storage of HDs

  Yes

  No

  N/A

• Compounding of HDs

  Yes

  No

  N/A

• Use and maintenance of proper engineering controls (eg, containment primary engineering control [CPECs], containment secondary engineering control [C‐SECs], and closed system drug transfer device [CSTDs]) to include SOPs for repairs, loss of power, moving, etc.

  Yes

  No

  N/A

• Hand hygiene and proper use of appropriate PPE based on activity (eg, receipt, transport, compounding, administration, spill, disposal).

  Yes

  No

  N/A

• Deactivation, decontamination, cleaning, disinfection SOPs include all of the following: Agents Used, Dilutions (if used), and Frequency.

  Yes

  No

  N/A

• Yes

  No

  N/A