Immersive Board Review

Compounding Self Assessment

Donald Cottman, Pharm.D., RPH

Compounding Pharmacist/Co-Owner
Pacific Compounding Pharmacy
Speaker Introduction
Donald Cottman, Pharm.D., RPh

Employment
Compounding Pharmacist & Co-Owner
Pacific Compounding Pharmacy, Stockton, CA (est 2002)

Education
B.S. Pharmacology UCSB ‘89; Pharm.D. USCF ‘97
Community Pharmacy Residency, UT/Reeves-Sain Drug Store ‘98

Contact
[email protected]
m 209-271-5394
Compounding Self Assessment
Learning Objectives
Describe the required written policies and procedures that direct compounding
Describe activities.

Explain the requirement of a comprehensive, written training program for staff

Explain including documentation of those activities.

Recognize the role of quality assurance in a compounding pharmacy and the

Recognize record keeping requirements of that program.

Recite Recite the types of records that must be provided to the BOP.

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Sources

www.pharmacy.ca.gov
Compounding Self-Assessment (17M
-39 Rev. 1/2022)

Community Pharmacy / Hospital Outp

atient Self-Assessment (17M-13, Rev
. 1/22)

Compounding Self-Assessment (17M

-39, Rev. 02/12)

Hospital Pharmacy Self-Assessment

(17M-14, Rev. 1/22)

Surgical Clinic Self-Assessment (17M

118, Rev. 1/24)

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Compounding Self Assessment (CSA)

Section 1: Write Policies Section 2: Train Staff

7 Training
16 CSP P&P
2 Limitation 13 CSP Air & water
21 CSP BUDs
5 NS P&P 18 CSP attire
22 CSP SD/MDVs
19 CSP training

Section 3: Assure Quality Section 4: Keep Records

6 Facilities 12 CSP area 3 Drug records 14 CSP operating

8 Assurance 17 CSP equipment 4 Labeling 15 CSP labeling
12 CSP area 20 CSP validation 10 Recalls 27 CSP recalls
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CSA Map

Misc Sections

9. USP
11. Contracting
15. CSP labeling

23. References
24. Renewals
25. Satellite Rx
26. Non-Resident Rx
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 Write Policies

2 Limitation

Section 1: 5 Non-Sterile P&P

Write Policies
16 CSP P&P

21 CSP BUDs

22 CSP SD/MDVs

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CSA 2. Limitations & Requirements

• Have a valid prescription & store limited • Have a master formula using compendial
quantity for continuity of care (2.1, 2.2) ingredients with BUD that DNE chemical
exp, formula stability, or BUD limits and
• Record furnishing to offices a reasonable
is based on RPH documented judgement
supply that can be safely made
(2.5 - 2.9)
[provider’s office - # patients/amount per
patient; veterinary practice NTE 120- • Extending sterile BUDs requires method
hour supply] (2.3) suitability, container closure integrity,&
stability tests (2.9.3)
• Drug has not been withdrawn by FDA for
safety, essentially a copy, or • Interstate dispensing requires annual
demonstrably difficult to compound (2.4) NABP/FDA Info Share and ADE reporting
in 12 hours to BOP (2.13)

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CSA 5. Non-Sterile P&Ps

• Written procedures for buying, • Methods and rationale to assure

formulating & compounding drugs and potency, BUDs (5.3.5)
cleaning, maintaining & operating
• Document P&P annual reviews and
facilities and equipment (5.1)
revision dates (5.3.7-8)
• Annually reviewed, notify staff of
• Storage policies and daily documentation
changes, and training on procedures
(5.3.1) of environment and out-of-range actions
(5.3.9-10)
• Recall process and steps to identify who
received doses (5.3.2)

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CSA 16. Sterile P&Ps

• Environmental sampling plan (surface, • CSP RPH ingredient approval, visual

glove, air) with Colony Forming Unit inspection, labeling (16.2.24)
(CFU) actions levels (16.2.1)
• Staff orientation, training, and
• Daily and monthly cleaning schedules competency evaluation (16.2.14)
(16.2.7)
• Hazardous (and infectious) handling,
• Certification and maintenance records of compounding, spill cleanup, and disposal
equip and isolators (16.2.9) (16.2.16)
• QA, temperature logs, record keeping
(16.2.19-21)

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CSA 21. CSP BUDs

• Does not exceed the shortest chemical • NS to S = 24hr room temp; 3d ref; 45d
exp date or combination stability (21.1) frozen (21.4)
• ISO 5 w/ante room, max 3 ingredients, • ISO 5 in segregated compound area, 3
max 2 punctures per container, S to S = 2 ingredients, two entries = 12 hours
days (48 hrs) room temp; 14 days (21.5)
refrigerator, 45 days frozen (21.2)
• Outside of ISO 5 label “For immediate
• Complex or multiple sterile vials pooled use” administration w/in 1-hour of start
used for multiple patients or one pt’s of compounding, limited to use to
multiple doses = 30h room temp; 9d ref; prevent loss of life, intense suffering,
45 frozen (21.3) and documented. (21.6)

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CSA 22. SDVs & MDVs

• Ampules are for immediate use, not • Multi-Dose Vials (MDVs) 28 days, unless
stored (22.1) specified by manufacturer (22.3)
• SDV punctured in non-ISO 5 air = 1hr in • If not stored or not labelled with BUD,
ISO 5 air = 6 hrs; discard if puncture time discard (22.3.1-2)
not noted (22.2.1-3)

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 USP Cat 1-2-3 and BUDs

USP Immediate use

Countertop, 3 ingred, 4 hr BUD
Primary Environmental Control (PEC = Hood)
• Category 1
No ISO 7 anteroom, 12hr / 24h
ref
• Category 2
Monthly and annual monitoring
• Category 3
Daily & intra batch monitoring

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 Section 1: Policies

CSA Section Key Concepts

Have a valid prescription, for a drug that hasn’t been withdrawn, and a master
2 Limitations
formula with documented BUD.
Have written procedures that you notify staff of changes, review annually, and
5 NS P&P
includes a recall process.
Have a monitoring, cleaning, and maintenance plan and logs of training and
16 CSP P&P
environment sampling.
21 CSP BUDs Set appropriate BUD based on the compounding ISO environment,
22 CSP Use ampules immediately, SDVs within 6 hours, and MDVs in 28 days unless
SD/MDVs manufacture indicates otherwise.

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Question 1
Which of the following statements is INCORRECT?

A. Once opened, ampules should not be stored unless opened in ISO 5

air, in which case they must be used within six hours.
B. A single dose vial punctured in an environment with air quality
worse than ISO Class 5 air must be labeled with a BUD and used
within one hour.
C. A multi-dose vial must be labeled with a BUD and used within 28
days of initial puncture unless otherwise specified by manufacturer.
D. A single dose vial punctured in an environment ISO Class 5 or better
must be labeled with a BUD and used within six hours.
 Train Staff

7 Training

Section 2: 18 CSP attire

19 CSP elements

Train Staff 20 CSP validation

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CSA 7. Training

• Keep documentation that staff* have • *staff includes facility maintenance staff,
skills and training to perform and are environmental (housekeeping) staff,
trained in all aspects of P&Ps (7.1) along with pharmacy staff

• Have ongoing training & competency

evaluation and document any and all
training (7.2)
• Demonstrate knowledge of P&P prior to
compounding (7.3)

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CSA 13. CSP Water & Air

• Area for sterile prep non-porous • NS to S in a positive-pressure ISO 7

cleanable surfaces, minimal traffic and buffer room with ISO 5 hood or barrier
storage sound PEC (13.2-3) isolator (13.1.5)
• Hot and cold running water (13.1.4) • Cytotoxic made in vertical laminar
hood (13.3)

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CSA 18. Sterile Attire

• PPE non-shedding covers head to feet • Gloves inspected for defects and
(18.1.1) regularly disinfected with 70% IPA
(18.1.5-8)
• Donned and doffed in ante-area, donned
from dirtiest to cleanest (18.1.2-3) • No rashes, sunburns, sores, resp infect,
make-up, nail polish/artificial nails
• No jewelry, piercings, earbuds, or
(18.1.9)
electronic devices (18.1.4)
• Persistently active alcohol in ante or
cleanroom on cleansed hands before
donning sterile gloves (18.1.6)

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CSA 19. Sterile Training

• Consultation is available to patient or • Training uses models, written tests,

caregiver on use, storage, handling and reassessed annually, kept 3 years (19.5.2)
disposal (19.1)
• All staff have training and demonstrated
competency, with records retained for 3
years past employment (19.3)
• Written program has at least aseptic
technique, QA, documentation,
calculations/terminology, hand hygiene,
gowning & gloving, conduct in the area,
sanitizing, maintenance, sterilizing, and
closure systems. (19.5.1)
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 Section 2: Training

CSA Section Key Concepts

Document staff have skills and training, demonstrate knowledge, and have
7 Training
ongoing training.
13 CSP Air & Have cleanable surfaced, running water, and proper positive pressure and
Water vertical flow hoods.
Don PPE in order, no jewelry, inspect gloves, and no wound or respiratory illness
18 CSP Attire
in cleanroom.
Keep training documents for 3 years of a comprehensive training program with
19 CSP Elements
competency demonstrations.

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Question 2
Which of the following statements about training is CORRECT?

A. Records of staff training and competence are retained for 12

months beyond the period of employment.
B. Consultation to patient and/or primary caregiver regarding use,
storage, handling, disposal and home compounding of sterile drugs
is available.
C. All pharmacy personnel engaged in sterile compounding have their
proficiency reassessed at least every 12 months.
D. Pharmacy staff proficiency assessments are comprised solely of
written testing of policy.
 Assure Quality

6 Facilities

Section 3 8 Assurance

12 CSP area

Assure Quality 13 CSP Air & water

17 CSP equipment

20 CSP validation
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CSA 6. Facilities

• Keep records of certifications of facility • Hazardous done in externally vented

and equipment (6.1) separate room
• Use and store equipment according to • Haz room 30 air changes per hr, neg
manufactures’ specifications (6.2) pressure 0.01-0.03 inches water
• Document calibrations prior to use (6.3) • External vented BSCs, smooth room
surfaces (6.5)

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CSA 8. Quality Plan

• Have a written plan for integrity, potency, • Reports kept with compounding record
quality, and labeled strength (8.1) (8.2.3)
• Plan has at least verify, monitor, and • Action plan for out-of-specification
review of process (8.2.1) results (8.2.4)
• Qualitative and quantitative analysis,
with frequency of testing [routine testing
done annually] (8.2.2)

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CSA 12. Sterile Area

• Area designated for sterile prep, • Sink allowed in ante-room, not in

restricted, constructed and ventilated to buffer space or w/in 3 feet of hood.
CCR, with each ISO room certified every (12.2.3.3)
6 months and records kept in the
• Sufficient cold storage with power
pharmacy. (12.2)
outage plan (12.2.3.4)
• Items stored to maintain integrity of
aseptic environment. (12.2.3.2)

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CSA 17. CSP Standards (part 1)

• Don’t use if environment fails to meet • Disinfect ISO 5 frequently, include

standards (17.1) beginning shift, Q 30 min when
compounding or before each lot, after
• Limit access to area and make sure all
spill and when needed (17.5)
equipment can be cleaned (17.2)
• PEC certified Q 6 months and as
• Daily surface cleaning floors and carts,
needed by tech meeting CETA and
and sterile disinfection ISO 5 surfaces
record kept for 3 years (17.6)
[germicidal/sterile water; use sporicidal
at least monthly] (17.4.1) • Isolators outside ISO 7 room meet
particle counts during transfers
• Monthly cleaning walls, ceiling, stools,
(17.6.3)
and shelves with non-shedding items
dedicated for cleanroom use. (17.4.3-4)
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CSA 17. CSP Standards (part 2)

• Haz PEC is externally vented, certified Q • Viable air sampling of 400-1000 L is done
6 months, and labelled as hazardous, Q 6 months by a qualified technician,
made wearing back-closing gown and under dynamic conditions (17.10.1-3)
two pairs of ASTM gloves (17.7)
• Viable surface sampling is done Q 6
• If rated by the manufacturer to ISO 5 months under dynamic conditions.
during transfer in/out of the isolator, it (17.10.4)
may be used in a non-ISO room, with
• When action levels are exceeded, identify
sterile gloves worn over isolator gloves
(17.8) CFU to genus level, and remediate
cleaning procedures (17.10.5)
• Well lighted, 68F or cooler (17.11)

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CSA 20. CSP Process Validation

• QA program monitors personnel • Personnel have initial garbing and

performance, equipment, facility and gloving competency [initial gloved
includes sanitization, recalls, and BUD fingertip samplings at least 3 times], and
justifications (20.1) re-evaluation annually (20.3-4)
• Revalidated personnel competency Q6 • Batch NS to S require sterility and
months for NS to S, and Q12 months for pyrogen testing prior to dispensing
S to S – must document (20.2)
• NS to S, single patient, 30 days opth or 5
• Document re-validation of aseptic days inhalation, don’t require sterility &
practices whenever PEC changes pyrogen testing (20.5.1)
(repaired) or unacceptable result (20.2.2)

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 Section 3: Assure Quality

CSA Section Key Concepts

Use equipment per manufacture specs, document certifications and calibrations, and
6 Facilities
assure ventilation and airflow.
8 Quality Plan Have a written plan for potency analysis and action plan for out of specification results.
Designated area is planned and certified every 6 months, has water and refrigeration
12 CSP Area
power outage plan.
Limit access to sterile area and have daily and monthly cleaning and disinfection
schedules.
17 CSP Standards
Conduct viable air sampling by a qualified technician and have an action plan for CFU
response.
Have QA that monitors equipment and people, with revalidations every 6 -12 months
based on type of compounding.
20 CSP Validation
Complete required testing on batches and set appropriate BUD for opth and respiratory rx
not tested.
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Question 3
Which of the following statements about cleaning is INCORRECT?

A. Disinfection, using a suitable sterile agent, occurs on all surfaces in the

ISO Class 5 PEC at the beginning of each shift.
B. Disinfection, using a suitable sterile agent, occurs on all surfaces in the
ISO Class 5 PEC at least every 30 minutes when staff are compounding.
C. Cleaning is done using a germicidal detergent and sterile water. A
sporicidal agent is used at least monthly.
D. Cleaning materials such as wipers and mops shall be non-shedding and
cleaned using a sporicidal agent after used to clean other areas of the
pharmacy.
Question 4
Which of the following statements about testing and certification is
CORRECT?

A. Certification and testing of primary and secondary engineering

controls are performed no less than every 12 months.
B. Certification is completed by a qualified technician who is familiar
with certification methods and procedures in accordance with CETA
Certification Guide for Sterile Compounding Facilities.
C. Certification records are retained for at least 2 years.
D. An annual video of smoke patterned test is used to document non-
turbulent unidirectional air flow patterns exist.
 Keep Records

3 Drug records

Section 4 4 Labeling

10 Recalls

Keep Records 14 CSP operating

27 CSP recalls

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CSA 3. Drug Records

• For each compound, have master and • Ingredients come from FDA registered
compounding log (3.1.1-2) suppliers, when possible, with CofA
(certificates of purity or analysis) in
• Log has what was made, when made,
English (3.3)
who made, RPH reviewer, qty, ingredient
detail (MFG exp date & lot #), pharmacy • Records are kept for three years (3.4)
assigned reference #, BUD, final quality
review (3.1.2.1-10)
• Keep chemical purchase, storage, and
destruction records (3.2)

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CSA 4. Labeling

• Affixed to container is label with name of • Unit-dose at least have name(s) of

compounding & dispensing pharmacy, active ingredients, strength, qty, lot
ingredient name(s), strength, IV diluent, number, and BUD (4.4)
storage, use (rate for IVs), BUD, date
• Hazardous include “Hazardous -
made, and lot number (4.1)
Dispose of properly.” label
• Statement on label or receipt that it was
compounded (4.3)

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CSA 10. and CSA 27. Recalls

• When recall occurs, contact recipient and

BOP in 12 hours if possible serious
adverse event and in CA (10.1)
• If recalled was dispensed to patient,
notify patient; if to prescriber notify
prescriber; if to pharmacy notify
pharmacy who notifies prescriber or
patient as appropriate (10.2,1-3)
• If harmed, report to MedWatch in 72 hrs
(10.3)

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CSA 14. CSP Operating Records

• Readily available evidence of training and • Cleaning logs, expired drug logs,
competency evaluations, hand hygiene, recalled drugs
garbing, media fill, and gloved fingertip
test results (14.1.1-3) • Master formulas, production logs, and
end-product testing results
• Viable air, surface sampling, smoke
studies (14.1.4) • For future use drug dispensed to
prescriber, date and recipient details
• Daily temperature logs (14.1.6)
[name, address, license type/#] (14.2)
• Room certifications and daily pressure • Retains all records for 3 years (14.3)
differentials (14.1.8)

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 Section 4: Keep Records

CSA Section Key Concepts

Have a master formula and compounding log showing what was done and the
3 Drug Records
ingredients used.
Put complete Rx information on label with “compounded” and “hazardous”, if
4 Labeling
appropriate.
10 Recalls Notify BOP in 12 hours if serious and notify recipient of the compound.
14 CSP Have available evidence of training, facility monitoring and cleaning logs, master
Operating formulas and logs, and keep for 3 years.
27 CSP Recalls Notify BOP in 12 hours if serious and notify recipient of the compound.

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Question 5
Which of the following statements about recalls is INCORRECT?

A. If a patient is harmed, report to MedWatch within 72 hours of being

advised of patient harm.
B. If the use or exposure to recalled drug may cause serious adverse
health consequences or death, report to the BoP immediately
C. The BoP is notified if the recalled drug was dispensed or intended
for use in California.
D. The patient is notified if recalled drug was dispensed directly to the
patient; the physician is not notified in this situation.
 Other CSA Sections
CSA Section Key Concepts
1. Definitions Know the definitions and vocabulary as defined by BOP

9. USP Applies Done consistent with current version of USP

11. CSP Contract to dispense CSP to another pharmacy required notice to BOP within thirty days.
Contracting
15. CSP Labeling Pharmacy phone number on label; All hazardous have “Hazardous-Dispose of properly”

Prior to license renewal, been inspected, copy of P&Ps, inspection reports provided, list of
24. Renewal CSPs made, for non-resident pharmacy reimbursement for inspection costs.
Only compound for hospital patients in same physical plant, for services administered in
25. Satellite Rx same plant.
26. Non-Resident Notice BOP in 10 days of any accreditations, 12 hours for any recalls, any complaint received
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Law Study Strategy Tips

• What lines involve communication requirements with patient, doctors, or BOP?

• What lines have specific written content requirements to provide?

• What lines have specific days for action?

• What lines have specific frequency of occurrence?

• What lines have defined measurements (e.g. air exchanges, potency ranges)

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