Download Objectives - South Carolina Society of Health

SC Board of Pharmacy
Being Prepared for
Board of Pharmacy
Inspections
Lee Ann Bundrick, R.Ph.
Administrator
110 Centerview Drive
Columbia SC 29210
Columbia,
(803) 896896-4700 Phone
(803) 896896-4596 Fax
Visit us on the Web:
www.llr.state.sc.us/POL/pharmacy
Objectives
Clelia Sanders, RPh
[email protected]
sandersc@llr sc gov
803--260803
260-9818
Applications/Forms






Inspection Report Forms
Non--Dispensing Drug Outlet
Non
Institutional Pharmacy
Nuclear Pharmacy
Retail Pharmacy Report 2
Sterile Permit Inspection Checklist
Non--Sterile Compounding Inspection
Non
Report



Describe the laws that pertain to
institutional pharmacy inspections.
Describe the laws and standards of
practice for sterile and nonnon-sterile
compounding.
Summarize the laws that pertain to
pharmacists, technicians and facilities.
40--4340
43-86(I)(1)
All drugs dispensed for use by inpatients of a hospital or
other health care facility, where the drug is not in the
possession of the ultimate user prior to administration,
shall meet these requirements:
 (a) The label of a single unit package of an individualindividualy
of p
packaging
g g of drugs
g shall
dose or unitunit-dose system
include:
 (i) the nonproprietary or proprietary name of the drug;
 (ii) the route of administration, if other than oral;
 (iii) the strength and volume, where appropriate,
expressed in the metric system whenever possible;
 (iv) the control number and expiration date;
date;
 (v) special storage conditions, if required.
1
Repackaging Log
Section 40
40--43
43--86 (I)(b)






Identify Repackager
Name of the Drug and Strength
Manufacturer, Lot Number, Expiration
Facility Control Number and Expiration
Quantity Repackaged
Initials of Pharmacist
Drugs for SelfSelf-Administration
Section 4040-4343-86(I)(2)
All drugs dispensed to inpatients for
self--administration shall be labeled in
self
accordance with item (4).
Section 4040-4343-86 (I)(4)
All drugs dispensed to ambulatory or outpatients shall
contain a label affixed to the container in which the drug
is dispensed including:
including:







(a) the name and address of the pharmacy dispensing
the drug;
(b) the name of the patient for whom the drug is
prescribed;
ib d
(c) the name of the prescribing practitioner;
(d) such directions as may be stated on the prescription
drug order;
(e) the date of dispensing;
(f) any cautions which may be required by federal or
state law;
(g) the serial number of the prescription drug order;
40--43
40
43--86(I)(4) Continued





Automated Dispensing Machines
Section 4040-4343-86(Q)
(g) the serial number of the prescription drug order;
(h) the name or initials of the dispensing pharmacist;
(i) the proprietary or generic name of the drug
dispensed and its strength, if more than one strength of
the drug is marketed;
(j) the brand name of the drug
g product
p
dispensed
p
or the
generic name of the drug product dispensed and its
manufacturer or labeler, either written in full or
appropriately abbreviated;
(k) when dispensing a prescribed medication, if a
pharmacist selects an equivalent drug product for a
name--brand prescribed drug, the generic drug name
name
must either be listed on the prescription label first
followed by the name
name--brand prescribed drug, or this
information must be affixed to the container on an
auxiliary label.
Investigational Drugs
Section 4040-4343-86(Q)
Machines used in the prescription drug distribution process
must be under the control of and are the responsibility of a
licensed pharmacist.

**Medications restocked in ADM’s must be checked
by a pharmacist or certified pharmacy technician
prior to restocking
**Pharmacy must restock the ADM’s and not a nurse
or other health care worker.

Investigational drugs which are used
within an institutional facility must
be stored in and dispensed from the
pharmacy only.
All information with respect to
investigational drugs must be
maintained in the pharmacy.
2
Inspection of Drug Storage Area
Section 4040-4343-86(Q)
All drug storage areas must be routinely
inspected by pharmacy personnel to ensure
that no outdated or unusable items are
present, and that all stock items are
properly labeled and stored.
**Be a spy and find the stash
**Off site NonNon-Dispensing Drug Outlet
Permits must keep a copy of monthly
inspection on site
Records
Separate for each Permit
(Z) A current record showing disposition of all restricted
pharmaceutical preparations, such as federal legend
drugs, exempt class V, insulin, controlled substances,
poisons and any other drugs so designated by the board
dispensed or sold …must be maintained for two years in
the prescription files or in the records of the permitted
facility showing the name of the person to whom
dispensed or sold, the name, strength, and quantity
dispensed or sold, and the date of the transaction.
**Must be able to trace medications from receiving to
dispensing, destroying, recalls, or transferring for each
permit.
Non-Sterile Compounding
NonSection 4040-4343-86(CC)


1.
2.
USP 795 & 797 Education
(3) Pharmacists engaging in compounding shall
maintain proficiency through current awareness
and training. Continuing education shall include
training
g in the art and science of compounding
g
and the rules and regulations of compounding.
Pharmacy technicians may assist the pharmacist
in compounding.

The pharmacist is responsible for training and monitoring
the pharmacy technician.
The pharmacy technician's duties must be consistent with
the training received.

FDA SEC. 503A. [21 USC §353a]
Pharmacy Compounding
Compounding
PPA 4040-43
43--86
86--CC(6)


Formulas/logs maintained manually or
electronically
Formulas must include:





Ingredients
Amounts
Methodology
Equipment
Any special information regarding sterile
compounding
The SC Board of Pharmacy has further
defined the Continuing Education to have
had 6 hours of initial training documented
and to have annual continuing education
or training of 4 hours in a documented
checklist in the employee files
This education does NOT have to be ACPE
or CME Category I
(I)
comply with the standards of an
applicable United States
Pharmacopoeia or National
Formulary monograph,
monograph if a
monograph exists, and the United
States Pharmacopoeia chapter on
pharmacy compounding;
**USP is considered the National
Standard for Compounding
3
Beyond Use Dating
USP 795
In the absence of stability information that is applicable to a specific
drug and preparation, the following maximum beyond
beyond--use dates are
recommended for nonsterile compounded drug preparations that are
packaged in tight, light
light--resistant containers and stored at controlled room
temperature unless otherwise indicated.
For Nonaqueous Liquids and Solid Formulations—
Formulations— Where the Manufactured
Drug
g Product is the Source of Active Ingredient—
Ingredient
g
— The beyondbeyond
y
-use date is not later
than 25% of the time remaining until the product's expiration date or 6 months,
whichever is earlier.
Where a USP or NF Substance is the Source of Active Ingredient—
Ingredient— The beyondbeyond-use
date is not later than 6 months.
For Water
Water--Containing Formulations (prepared from ingredients in solid form)—
form)—
The beyondbeyond-use date is not later than 14 days for liquid preparations when stored at
cold temperatures between 2 and 8 (36 and 46 F).
For All Other Formulations—
Formulations— The beyond
beyond--use date is not later than the intended
duration of therapy or 30 days, whichever is earlier. These beyondbeyond-use date limits
may be exceeded when there is supporting valid scientific stability information that is
directly applicable to the specific preparation (i.e., the same drug concentration
range, pH, excipients, vehicle, water content, etc.).
Compounding Logs
PPA 4040-43
43--86 (CC)





Comprehensive and include ingredients,
amounts, methodology, equipment
Date of compounding
D t off expiration
Date
i ti
Assign Compound Batch/Lot number
List all ingredients


Lot number
Expiration
SECTION 40
40--43
43--88
Compounding
Standards for preparation, labeling, and distribution of
PPA 4040-43
43--86
86--CC(6)


Pharmacist ensures accurate
weights/measurements at each stage of
compounding procedure
Procedures put in place to monitor output of
compounded prescriptions





Capsule weight variation
Adequacy of mixing
Clarity
pH of solutions
Procedures to prevent microbial contamination when
medications are purported to be sterile
sterile products by pharmacies
(B) The pharmacy shall have a separate area designated for placement
of the Class 100 laminar airflow hood, which must:
(1) be constructed so as to allow visual observation
observation;;
(2) not be
b a thruway
h
for
f traffic;
ffi
(3) have walls, floor, ceiling, and work surfaces constructed of
materials that are nonporous and do not produce particulate matter;
(4) be ventilated in a manner that will not interfere with the
outward flow of air from the hood;
(5) not be used for unpacking bulk supplies;
(6) not be used for storage of bulk supplies and materials; and
(7) have an eye wash station and sink readily accessible to the area.
Policies and Procedures Address
Cleaning and Maintenance of Facility
40--43
40
43--88(C)
Adequate area for preparation of
sterile products

Only furniture, equipment, supplies necessary for compounding in
buffer area and ante area

Surfaces nonnon-porous, smooth, nonnon-shedding, impermeable,
cleanable, and resistant to disinfectants

No drains in buffer area




Detailed for cleansers, disinfectants, and non
non--shedding wipe and
mop material

Address actual procedures for cleaning hoods, buffer, and ante
areas with schedules and disinfectants used
Low to Medium risk can have ante area (ISO 8) and buffer area
(ISO 7) which have line of demarcation. High risk must have
separate ante room and clean room

If Hazardous preparation need a negative pressure room (ISO 7)
that feeds into an positive pressure ante area of ISO 7. It is okay
to share ante room with NonNon-hazardous preparation

Need schedule for cleaning of equipment, hoods, buffer, ante,
floors, walls and shelving which insures that the time cleaned would
be separated from environmental testing
Prefilter Changes must be changed in accordance with
manufacturer’s specifications
Sink shall be in ante area (room/area)
4
Clean Room and Hoods Certified
Every 6 Months (Per USP 797)



Maintain Storage Areas (Pharmacy,
Refrigerator, Freezer, and Compounding
Area) at Proper Temperature
Need to have separate reports for each hood,
buffer area, and ante area
Will need to look at places with highest particle
countt and
d suggestt environmental
i
t l ttesting
ti iin
those areas
Viable airborne micromicro-organisms should be
provided and will be sent after the incubation
period




Velocity Meter from buffer area to ante area if using a line of
demarcation (0.2 M/sec or 40 ft/min)

Should document at least daily and may use continuous monitor,
but should be able to show that continuous has alarms or report
Logs for Environmental Testing of
Sterile Compounding Area
Logs must have date, time and initials
Specific to each area and hood (hood – per
shift; floors in Buffer and Ante Areas &
C
Counters
t
d
daily;
il Walls,
W ll ceilings,
ili
shelves,
h l
and
d
bins in Buffer and Ante Area monthly


Changing of pre
pre--filters


Times separated by shift from environmental
testing
Adequate Equipment and Devices in
Use for the Level of Compounding
Performed. Calibration/Verification
Logs in Place for Equipment.


Pressure Differential Monitoring - Pressure gauge from clean
room to ante area( 0.02 – 0.5 and not <30 ACPH and ante area
to general area not <5Pa(0.02)

Logs for Cleaning of Sterile
Compounding Area

Logs for Temperature - 68 F(20 C) or at comfortable temp not >
76 F and Humidity – 35 to 60 relative humidity
Should be doing
g volume verification on
compounders
Need to review changes in weight
variation
Logs shall show location of testing
Logs need to show results and
incubation times
Logs indicate time, date, and initials of
person performing testing
Evidence of Training and/or Continuing
Education in Compounding of Sterile
Products Annually



Need documentation of training for any
pharmacist or technician involved in
compounding (checking or making)
Training documentation should have articles or
certificates
Didactic Review, Pass Written test, 3 GloveGlove-Tip
Test Annually for Low and Medium – SemiSemiannually High Risk
5
Personnel Understands and Uses
Appropriate Outer and Over
Over--wear Items
(Gowning, Gloving, and Related
Supplies)
Logs for Personnel for Media Fill Sufficient
for Risk Level of Compounded Products

Annually for Low and Medium Risk

Semi--Annually for High Risk
Semi

Media fill appropriate for Risk Level

Finger Tip Testing x3 initially and then
annually for Low and Medium and semisemiannually for High Risk




Compounding Logs


For extended Beyond Use Dating

Validation of nonnon-compendium products
Formulas electronic or written
Sterilization Used and Documentation of
Bubble Test if applicable
Logs for Testing for Pyrogens,
Sterility, and Potency

Must be garbed for Low Risk with 12
hour or less BUD
Policies and Procedures Present which
Address Facilities’ Product Testing and
Validation
Adequate Formulas and Logs
Maintained for NonNon-sterile to
Sterile products

Need to know appropriate order and
reuse of coats or shoes
For High Risk with 25 units or > per
compounding session
May need Potency Testing for
Compounding Processes
Facility Maintains a Quality Assurance
Program which is Reviewed and Updated
Annually


Need review of all testing,
documentation for environment and
staff,
Should not have to look through all files
– should have synopsis
6
Policy and Procedure #147
Remote Medication Order Processing








Receiving, interpreting, or clarifying medication
orders.
Entering or transferring medication order data.
Performing prospective drug use review.
Obtaining substitution authorizations.
Interpreting and acting on clinical data.
Performing therapeutic interventions.
Providing drug information
Authorizing the release of a medication for
administration.
SECTION 40-43-30. Definitions
(41) "Pharmacy" means a location for which
a pharmacy permit is required and in
which prescription drugs and devices are
maintained compounded,
maintained,
compounded and dispensed
for patients by a pharmacist. This
definition includes a location where
pharmacy--related services are provided by
pharmacy
a pharmacist.
Main Points for
Remote Order Enter
SECTION 40-43-30. Definitions

(44) "Practice of pharmacy" means the interpretation, evaluation, and
dispensing of prescription drug orders in the patient's best interest;
participation in drug and device selection, drug administration,
prospective drug reviews, and drug or drugdrug-related research;
provision of patient counseling and the provision of those acts or
services necessary to provide pharmacy care and drug therapy
management; and responsibility for compounding and labeling of
drugs and devices, (except labeling by a manufacturer, repackager,
or distributor or nonprescription drugs and commercially packaged
legend drugs and devices) proper and safe storage of drugs and
devices and maintenance of proper records for them; or the offering
or performing of those acts, services, operations, or transactions
necessary in the conduct, operation, education, management, and
control of pharmacy.
Pharmacy Technicians
"Pharmacy technician" means an individual
other than an intern or extern, who assists
in preparing, compounding, and
dispensing medicines under the personal
supervision of a licensed pharmacist and
who is required to register as a pharmacy
technician.




Must be from Permitted site to Permitted site
…..Not From Home
In state Pharmacist must be licensed in South
Carolina
O t off St
Out
State
t th
the Ph
Pharmacist
i t iin Ch
Charge for
f the
th
Permitted site must be licensed in SC.
Contracts must be in place be in place with
permitted sites
Pharmacists may be an employee or contract
employee
State Certified Pharmacy
Technician
(C) Notwithstanding any other provision of this
chapter, a supervising pharmacist may
authorize a certified pharmacy technician to
( ) receive and initiate verbal telephone
(1)
p
orders;;
(2) conduct one time prescription transfers;
(3) check a technician's refill of medications if the
medication is to be administered by a licensed health
care professional in an institutional setting;
(4) check a technician's repackaging of medications from
bulk to unit dose in an institutional setting.
**A pharmacy intern can not check another technician
without a pharmacist signing off on the process also.
7
Questions?
Questions can always be addressed to
the Board staff. Feel free to call, email
or fax.
8