Guidance Document 11023 Virginia Board Of Pharmacy Practitioner Of

guidance document: 110-23 virginia board of pharmacy practitioner of the healing arts selling controlled substances inspection deficie

Guidance Document: 110-23
Virginia Board of Pharmacy
Practitioner of the Healing Arts Selling Controlled Substances
Inspection Deficiency Monetary Penalty Guide
Major Deficiency
Law/Reg Cite
Conditions
$ Penalty
1.
Practitioner selling on an expired license.
18VAC110-30-30
Per individual
100
2.
Selling by unauthorized individuals.
§ 54.1-3302 & 18VAC110-30-20
Per individual
500
3.
Change of location, remodel, or addition of a selling location
without application or Board approval.
18VAC110-30-80
must submit an application and fee
250
4.
More than one person present in the storage and selling area to
assist in performance of pharmacy technician tasks.
18VAC110-30-40 & 18VAC110-30-130
per each person
First Offense – Minor 3 deficiency
Second Offense – Major 4 deficiency
100
5.
Persons assisting in the performance of pharmacy technicians
duties other than a registered pharmacy technician or licensed
nurse or physician assistant who has received training in
technician tasks.
18VAC110-30-40
Per individual
250
6.
Refrigerator/freezer temperature out of range greater than +/- 4
degrees.
18VAC110-30-110
determined using inspector’calibrated thermometer
100
Drugs may be embargoed
7.
Insufficient enclosures or locking devices.
18VAC110-30-120
Major 7 if there is evidence that non-compliance contributed to a drug
loss.
Minor 6 if no drug loss.
500
8.
Storage of drugs for sale not in the storage and selling area.
18VAC110-30-90
500
9.
Alarm not operational or not being set. Enclosure not locked and
alarmed when licensee not on duty.
18VAC110-30-120
1000
10.
Unauthorized access to alarm or locking device to the drug storage
and selling area.
18VAC110-30-120 & 18VAC110-30-130
1000
11.
No biennial inventory, or over 30 days late, or substantially
incomplete, i.e., did not include all drugs in Schedules II-V.
54.1-3404 & 18VAC110-30-180
Minor 23 if only expired drugs not included in inventory.
500
12.
Theft/unusual loss of drugs not reported to the Board as required
or report not maintained.
54.1-3404
per report/theft-loss
250
13.
Hard copy prescription or record of sale not maintained or
retrievable as required.
18VAC110-30-190
250
14.
Automated data processing records of sale not maintained as
required.
18VAC110-30-200
250
15.
Practitioner not verifying or failing to document verification of
prescriptions sold.
18VAC110-30-40
10% threshold for documentation
500
16.
Practitioner not checking and documenting repackaging.
18VAC110-30-210
Review all entries for 5 drugs for six consecutive months. Deficiency
if 10% or more are not compliant
250
17.
Practitioner not documenting final verification of non-sterile
compounding.
54.1-3410.2, 18VAC110-30-40
500
18.
Practitioner not documenting final verification of sterile
compounding.
54.1-3410.2 18VAC110-30-40
5000
19.
Schedule II through VI drugs are being purchased from a wholesale
distributor, warehouse, or other entity not licensed or registered
by the Board or from a pharmacy not in compliance.
110-30-255
250
20.
No clean room.
54.1-3410.2
10000
21.
Have clean room, but not all physical standards in compliance,
e.g., flooring, ceiling.
54.1-3410.2
2000
22.
Performing sterile compounding outside of a clean room.
54.1-3410.2
Compliant clean room present but not utilized for preparation of
compounded sterile drug products.
3000
23.
Sterile compounding of hazardous drugs performed in an area not
physically separated from other preparation areas.
54.1-3410.2
2000
24.
High-risk drugs intended for use are improperly stored.
54.1-3410.2
5000
25.
Certification of the direct compounding area (DCA) for compounded
sterile preparations indicating ISO Class 5 not performed by a
qualified individual no less than every 6 months and whenever the
device or room is relocated, altered, or major service to the
facility is performed.
54.1-3410.2
Review 2 most recent reports; certification must be performed no later
than the last day of the sixth month from the previous certification
3000
26.
Certification of the buffer or clean room and ante room indicating
ISO Class 7 / ISO Class 8 or better not performed by a qualified
individual no less than every six months and whenever the device
or room is relocated, altered, or major service to the facility is
performed.
54.1-3410.2
Review 2 most recent reports;
certification must be performed no later than the last day of the
sixth month from the previous certification
27.
Low or medium-risk compounded sterile preparations assigned
inappropriate beyond use date (BUD).
54.1-3410.2
1000
28.
No documentation of sterilization methods or endotoxin pyrogen
testing for high-risk level compounded sterile preparations or
high risk compounded sterile preparations assigned inappropriate
beyond use date (BUD).
54.1-3410.2
5000
29.
No documentation of initial and annual (12 months) media-fill
testing for persons performing low and medium-risk level
compounded sterile preparations.
54.1-3410.2
Review 2 most recent reports. Media-fill testing must be performed no
later than the last day of the twelth month from the date the previous
media-fill test was initiated.
500
30.
No documentation of initial and semi-annual (6 months) media-fill
testing for persons performing high-risk level compounded sterile
preparations.
54.1-3410.2
Review 2 most recent reports. Media-fill testing must be performed no
later than the last day of the sixth month from the date the previous
media-fill test was initiated
5000
31.
Documentation that a person who failed a media-fill test has
performed low or medium risk level compounded sterile preparations
after receipt of the failed test result and prior to retraining
and receipt of passing media-fill test.
54.1-3410.2
500
32.
Documentation that a person who failed a media-fill test has
performed high-risk level compounded sterile preparations after
receipt of the failed test result and prior to retraining and
receipt of passing media-fill test.
54.1-3410.2
5000
33.
Compounding using ingredients in violation of §54.1-3410.2.
54.1-3410.2
1000
34.
Compounding copies of commercially available products.
54.1-3410.2
per Rx dispensed up to maximum of 100 RX or $5000
50
35.
Unlawful compounding for further distribution by other entities.
54.1-3410.2
500
Minor Deficiencies
If five (5) or more minor deficiencies are cited, a $250 monetary
penalty shall be imposed. Another $100 monetary penalty will be added
for each additional minor deficiency over the initial five.
Minor Deficiency
Law/Regulation Cite
Conditions
1.
Selling drugs from a location prior to approval by the Board.
18VAC110-30-80
2.
Special/limited-use scope being exceeded without approval.
18VAC110-30-20
3.
More than one person present in the storage and selling area to
assist in performance of pharmacy technician tasks.
18VAC110-30-40 & 18VAC110-30-130
per each person
First Offense – Minor 3 deficiency
Second Offense – Major 4 deficiency
4.
No site-specific training program and manual.
18VAC110-30-40
5.
No documentation of successful completion of site-specific
training program.
18VAC110-30-40
6.
Insufficient enclosures or locking devices.
18VAC110-30-120
Major 7 if there is evidence that non-compliance contributed to a drug
loss.
Minor 6 if no drug loss.
7.
Emergency access alarm code/key not maintained in compliance.
18VAC110-30-120
8.
Selling and storage area, work counter space and equipment not
maintained in a clean and orderly manner.
18VAC110-30-90
must have picture documentation
9.
Controlled substances for ultimate sale not clearly separated from
other drugs (i.e. samples, drugs for administration).
18VAC110-30-90
10.
Storage of prescriptions prepared for delivery not in compliance.
18VAC110-30-140
11.
Expired drugs in the working stock.
18VAC110-30-150
10% threshold
Minor Deficiency
Law/Regulation Cite
Conditions
12.
No prescription balance sensitive to 15mg and weights or
electronic scale if engaged in dispensing activities that require
the weighing of components.
18VAC110-30-110
13.
Sink with hot and cold running water not available within the
immediate vicinity of the selling and storage area.
18VAC110-30-90
14.
Failure to conspicuously display sign in a public area advising
patients of their right to choose where to have their
prescriptions filled.
18VAC110-30-170
15.
Documentation of patient’s choice to have prescription filled by
practitioner not in compliance..
18VAC110-30-170
16.
No thermometer or non-functioning thermometer in
refrigerator/freezer, but temperature within range, +/-4 degrees
Fahrenheit.
18VAC110-30-110
determined using inspector's calibrated thermometer
17.
No current dispensing information reference source.
18VAC110-30-110
18.
Labels do not include all required information
18VAC110-30-220
10% Threshold
Review 25 prescriptions
19.
Special packaging not used, no documentation of request for
non-special packaging, sign not posted near the compounding and
selling area advising patients nonspecial packaging may be
requested.
18VAC110-30-240
20.
Repackaging records and labeling not kept as required or in
compliance.
18VAC110-30-210
10% threshold
21.
Packaging not compliant with USP-NF standards.
18VAC110-30-230
Minor Deficiency
Law/Regulation Cite
Conditions
22.
Biennial inventory taken late but within 30 days.
54.1-3404 & 18VAC110-30-180
23.
Inventories taken on time, but not in compliance, i.e., no
signature, date, opening or close, Schedule II drugs not separate,
failure to include expired drugs.
54.1-3404 & 18VAC110-30-180
24.
Records of receipt (e.g.invoices) of controlled substances not
maintained as required.
§ 54.1-3404 & 18VAC110-30-180
25.
Offer to counsel not made as required.
18VAC110-30-40
26.
Prospective drug review not performed as required.
18VAC110-30-40
27.
Improper disposal of unwanted drugs.
18VAC110-30-160
28.
Particle counts, environmental sampling, and smoke pattern testing
not performed under dynamic conditions.
§54.1-3410.2
29.
Equipment for sterile compounding does not comply with USP-NF
standards.
18VAC110-30-110 & § 54.1-3410.2
30.
Equipment for non-sterile compounding does not comply with USP-NF
standards.
54.1-3410.2
Adopted 03/26/2014 Page 10 of 10