Arizona Board of Pharmacy Compounding Task Force May 1, 2013 Minutes

THE ARIZONA STATE BOARD OF PHARMACY
HELD A COMPOUNDING TASK FORCE MEETING ON MAY 1, 2013
MINUTES FOR COMPOUNDING TASK FORCE MEETING
Call to Order – May 1, 2013
Chairman John Musil convened the meeting at 10:00 A.M. and welcomed the audience to the
meeting.
Roll Call
The following Task Force Members were present: Chairman John Musil, Tom Van Hassel (via
telephone), Rich Monty (via telephone), Dana Reed-Kane (via telephone), Eric Bauer (via
telephone), Linda Carboni, Dennis Waggoner, Danielle Evans (via telephone), and Sandra
Sutcliffe.
Review of Rule R4-23-410 – Current Good Compounding Practices
Chairman Musil opened the discussion by stating that the task force would do a line by line
review of R4-23-410 that was revised by Ms. Sutcliffe and incorporated the recommendations
made by the task force at the last meeting.
R4-23-410 – Section A
The task force did not recommend any changes for Section A.
R4-23-410 – Section B - Component Selection
Mr. Musil stated that he had concerns about section 2 where it states that a certificate of analysis
(CofA) must be obtained for all components for compounding that do not meet the requirements
of subsection (1) (a). Mr. Musil stated that re-packagers often do not provide a certificate of
analysis because they do not do an analysis of the product. Mr. Musil stated in that case the
certificate of analysis would come from the point of origin.
Ms. Reed-Kane recommended that if the company does not provide a certificate of analysis then
the pharmacy would have to do their own analysis.Mr. Wand stated that the rule could be written to state that a certificate of analysis is obtained
and/or verified by the pharmacy.
The task force members recommended that Certificate of Analysis should be defined in the
definitions.
R4-23-410 – Section C- Training and Personnel
Mr. Musil stated that the rule reads that competency assessments must be maintained for two
years and questioned how long records should be kept for employees that have terminated their
employment.
Ms. Sutcliffe stated that the record retention requirements for employees that have terminated
employment are usually found in the policies and procedures of the individual pharmacy.
Mr. Van Hassel asked how long the compounding logs are kept. Ms. Sutcliffe stated that she
selected two years but the task force could change the requirement.
Ms. Sutcliffe stated that the records requirement could be changed to keep the records for three
years the same as other records are maintained. Ms. Sutcliffe recommended that the rule could
read that a pharmacy needs to maintain an ongoing record of all personnel compounding for
three years.
Ms. Reed- Kane asked if the record retention would include interns that were on rotation at the
pharmacy.
Mr. Musil replied yes that it would include anyone that compounded medications.
R4-23-410- Section D
Mr. Musil stated this section was changed to require both the permit holder and pharmacist in
charge to ensure the security, safety, and quality of a compounded pharmaceutical product.
R4-23-410 – Section E – Compounding Facilities
Mr. Musil stated that this section adds a minimum non-sterile pharmaceutical compounding area
of not less than 60 square feet except for pharmacies that been permitted or remodeled prior to
a specified date may continue to meet the previous requirements.
Ms. Reed- Kane asked about a pharmacy that has never remodeled their space. Ms. Sutcliffe
stated that the previous requirements would remain in place.
Mr. Van Hassel stated that he feels that this would have an economic impact on pharmacies.
Ms. Sutcliffe stated that this requirement would not affect pharmacies compounding simple or
moderate compounds. Ms. Sutcliffe stated that it would just affect pharmacies preparing complexpreparations.
Ms. Carboni asked if the pharmacy would be required to remodel their pharmacy. Ms. Sutcliffe
stated that they would need to remodel if they were compounding complex preparations.
Mr. Musil stated that he had some concerns because some hormone and antibiotic preparations
are considered to be simple and moderate compounds.
Mr. Musil stated that he had concerns about employee’s exposure to hormones.
Mr. Wand stated that certain preparations could be excluded in the definition of simple
compounds.
The task force members decided that the following products would be excluded from
simple and moderate compounds: hormones, antibiotics, chemotherapeutics, and cytotoxics.
The task force members decided to define the following compounding terms: simple, moderate,
and complex.
Ms. Sutcliffe asked if the compounding of hazardous compounds should be conducted in a
powder hood.
Mr. Musil stated that he felt that Narcotics should be compounded in a powder hood.
Mr. Musil stated that there were some concerns about the 60 square foot requirement for
a non-sterile compounding area. Mr. Musil stated that he feels that the area should be isolated
from the pharmacy dispensing area.
The task force members decided that Section E (2) (ii) should read is isolated from the
dispensing area instead of is isolated from other pharmacy functions.
Ms. Sutcliffe asked how the task force members would like to restrict entry or access.
Mr. Van Hassel stated that he feels that a designated area could be designated in the pharmacy
and a separate room would not be needed. Mr. Van Hassel stated that there would
have to be a designated room for sterile compounding and for non-sterile compounding a
designated area would be fine.
Mr. Wand asked if plastic strips could be used to restrict the area.
Mr. Musil stated that he would have no problem with the plastic strips as long as there is a
defined area.
Mr. Van Hassel stated that it should be 60 square feet of contiguous space.
The task force decided to add in Section E (2) (b) that the space provides a non-steriledesignated compounding area.
Mr. Van Hassel recommended that non-sterile compounding area be defined in definitions.
R4-23-410 – Section F – Compounding Equipment
The task force agreed to adding #2 which states that compounding of hazardous non-sterile
compounds must be made in a powder containment hood.
The task force decided to define hazardous non-sterile compound in definitions.
R4-23-410 – Section G
The task force did not recommend any changes for Section G.
R4-23-410 – Section H – Handling and Storage of Components, Containers, and
Closures
The task force did not recommend any changes for Section H.
R4-23-410 – Section I – Compounding Documentation
Ms. Sutcliffe stated that this section was changed to indicate that the documentation could be
either be in a written or electronic format.
Ms. Sutcliffe stated that the compounding record section was changed from initials or name of
the licensee to identity of the licensee.
R4-23-410- Section J – Quality Controls
Ms. Sutcliffe stated that changes were made to allow the procedures for documentation to be
kept in either written or electronic format.
Mr. Musil asked if there were any other testing for variability that should be added to #4.
Mr. Bauer stated that a final visual inspection should be added.
Mr. Musil suggested that final visual inspection should be added to both #2 and # 4 in that
section.
R4-23-410 – Section K - Re-packaging of powders
Mr. Musil stated that if repackaging the component into smaller containers the beyond use
date should be consistent.
R4-23-410 – Section L – Beyond use datesMr. Van Hassel asked if other sources could be used to determine the expiration date other
than official compendium.
Ms. Reed-Kane stated that PCAB allows the pharmacist to use their professional judgment in
determining the beyond use date. Ms. Reed-Kane stated that the pharmacist could use a
research paper or other documentation.
The task force decided to change the statement from in the absence of stability information to
in the absence of documented stability information.
Mr. Musil stated that they could use internal stability studies.
Mr. Bauer left the phone call at this time.
R4-23-410 – Section M – Labeling
The task force did not recommend any changes for Section M.
R4-23-410 – Section N
The task force did not recommend any changes for Section N.
R4-23-410 – Section O – Compounding in Excess of Prescription
Mr. Musil stated that he feels that to compound in excess there should be some kind of
documentation.
Mr. Van Hassel suggested that the statement should be changed from shall establish a
history of compounding valid prescriptions to shall establish a documented history of
compounding valid prescriptions.
Mr. Van Hassel stated that in #2 the label on the container should include the beyond use date
and storage information.
R4-23-410 – Section P
The task force did not recommend any changes for Section P.
R4-23-410 – Section Q – Compounding for Office Administration
Ms. Sutcliffe stated that Letter g was added to this section which states that the product is not for
resale or distribution.R4-23-410 – Section R
The task force did not recommend any changes for Section R.
R4-23-410 – Section S – Compounding Commercially Available Products
Mr. Musil stated that a product that is commercially available could not be compounded except
when there is documented shortages.
Mr. Musil stated that a documented clinical need should exist for compounding a commercially
available FDA product.
Ms. Sutcliffe asked if it should be a patient specific reason.
Mr. Musil stated that there should be a documented clinical need such as a clinically relevant
reason.
Mr. Musil summarized by stating that a like product could be compounded if there is a
documented clinical shortage or there is a documented clinical need for the patient.
Mr. Musil stated that office use medications should only be compounded for the same reasons.
It was recommended to move Section S before Section Q.
R4-23-410 – Section T
Mr. Musil recommended to change #4 to read written or electronic manual.
R4-23-410 – Section U
Ms. Sutcliffe stated that she could add each section in the rule to be required in the policies
and procedures.
R4-23-670 – Sterile Pharmaceutical Products
Mr. Musil stated that he would like to see ante room and sterile product compounding
area defined.
Mr. Musil stated that he feels that an ante room should be in addition to the square footage of the
compounding area.
Ms. Carboni asked if there should be a square footage requirement for the ante room.
Mr. Musil recommended that the ante room should meet ISO 7 requirements.
Mr. Van Hassel stated that ante room,sterile room, and storage room should be included in thedefinitions.
Mr. Musil stated that there should be a sink in the ante room and gowning area.
Mr. Musil was asked if an ante room would be required in all instances for example if a glove
box was in the use.
Mr. Musil stated that an ante room would be required.
Ms. Sutcliffe asked if 100 square feet would be required if someone was using a glove box.
Mr. Musil stated that the size of the room would remain the same no matter what type of hood
was being used.
Mr. Monty asked if a separate chemo room would be required.
Mr. Van Hassel recommended defining negative pressure in the definitions.
Ms. Carboni stated that some hospitals have a glove box in a separate room to do chemo.
Mr. Van Hassel stated that cytotoxic should be defined in the definitions.
Mr. Musil stated that the sterile preparation area should have a separate HVAC system from the
dispensing pharmacy.
In section C, it was recommended to add testing to #1.
Mr. Monty asked if the task force should specify criteria for who can certify the rooms.
Mr. Wand stated that the Board could approve a list of individuals who could certify the room.
Ms. Carboni asked about the daily monitoring of the temperature of the room.
Mr. Wand stated that the temperature could be monitored remotely.
The task force members decided to add temperature under #4 for supervisory controls and
verification procedures.
The task force members wanted “during excursion” added under #4 for supervisory controls and
verification procedures.
Ms. Sutcliffe asked if this was for both refrigerator and room temperatures.
The task force members decided to review risk in 797 and discuss at the next meeting.Call to the Public
Chairman Musil announced that interested parties have the opportunity at this time to address
issues of concern to the task force; however the task force may not discuss or resolve any issues
because the issues were not posted on the meeting agenda.
No one came forth.
Topics for next meeting
1. Concerns for Senate Health Draft
2. Office Use prescriptions – percentage
3. Interstate and intrastate compounding
Next Meeting
The Task Force will try to hold their next meeting prior to or at the Convention in June.
The meeting adjourned at 12:00 noon.