AGENDA ITEM 18 – Wells Pharmacy Network – Case 14-0019-PHR
President Foy asked Ms. Sutcliffe to address this agenda item.
Ms. Sutcliffe stated that she and Mr. Waggoner conducted an inspection at the Florida facility at
the request of the Board.
Ms. Sutcliffe stated that the personnel were cordial and were willing to work with them. Ms.
Sutcliffe stated that they were taken on a tour of the facility.
Ms. Sutcliffe stated that they observed that the pharmacist did not verify each step during the
compounding process.
Ms. Sutcliffe stated that they had 10 random prescriptions/orders pulled from the Arizona report.
Ms. Sutcliffe stated that there were issues with Beyond Use Dates (BUD). Ms. Sutcliffe stated
that there appeared to be issues with the BUD for Trimix. Ms. Sutcliffe stated that they were
placing a 6 month date on Trimix when it was frozen but should have a 1 month date if
refrigerated. Ms. Sutcliffe stated that there was no indication of a BUD recommendation for the
individual components prior to compounding, as Trimix.
Ms. Sutcliffe stated that their sterility testing policies indicate that they follow USP 71. Ms.
Sutcliffe stated that is not what they found when looking at the compounds. Sterility sampling
was not compliant for number of containers/total volume tested.
Ms. Sutcliffe stated that they were inconsistencies in all 10 Arizona records pulled
Ms. Sutcliffe stated that they looked at the Last FDA 483 letter and noted violations. Ms.
Sutliffe stated that they also noted that the sampling plan is not compliant with USP 71
requirements. Ms. Sutcliffe stated that there was a breach of ante room protocol.
Ms. Sutcliffe stated that additional records were obtained and they also contained missing or
incomplete information.
Ms. Sutcliffe stated that the Pharmacy must have an NABP inspection in order to renew their
Texas license. Ms. Sutcliffe indicated that they would be sending a copy of the inspection to the
Board Office.
Dr. Musil asked if they had a current non-resident permit. Ms. Sutcliffe replied yes. Ms.
Sutcliffe stated that a new Pharmacist in Charge started in August. Ms. Sutcliffe stated that the
new pharmacist in charge is aware of the issues but has not been able to implement changes yet.
Mr. McAllister stated that the Board could wait for the NABP inspection or the Board could take
action based on the Compliance Officer’s inspection.
Mr. Kennedy asked how long it would take to schedule the NABP inspection. Mr. McAllister
stated that it could take up to 8 weeks.
Mr. Van Hassel stated that he felt that we should offer a consent based on our findings.
On motion by Mr. McAllister and seconded by Mr. Van Hassel, the Board unanimously
agreed to offer Wells Pharmacy Network a Consent Agreement with the following terms:
1. Reimburse the Board for the Compliance Officer’s trip
2. A civil penalty of $1, 000 dollars for each violation – 9 violations
3. Probation for 1 year. The probation can be ended by passing an inspection by
an Arizona Compliance Officer. The inspection and related costs will be paid
by the Pharmacy. The pharmacy must pass the inspection and then they can
petition the Board for removal of the probation.
A roll call vote was taken. (Ms. Locnikar – aye, Dr. Musil-aye, Mr. Francis- aye, Mr. Van Hassel
– aye, Mr. Minkus- aye, Mr. Kennedy – aye, Mr. McAllister – aye, and Dr. Foy – aye)
Mr. Lee suggested that the Board may also want to offer the Pharmacy a Consent Agreement for
Voluntary Surrender of their license and the Pharmacy could choose which agreement they
would like to sign.
On motion by Mr. McAllister and seconded by Mr. Van Hassel, the Board unanimously
agreed to also offer the Pharmacy a Consent Agreement for Voluntary Surrender of their license.
A roll call vote was taken. (Ms. Locnikar – aye, Dr. Musil-aye, Mr. Francis- aye, Mr. Van Hassel
– aye, Mr. Minkus- aye, Mr. Kennedy – aye, Mr. McAllister – aye, and Dr. Foy – aye)
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President Foy asked Ms. Sutcliffe to address this agenda item.
Ms. Sutcliffe stated that she and Mr. Waggoner conducted an inspection at the Florida facility at
the request of the Board.
Ms. Sutcliffe stated that the personnel were cordial and were willing to work with them. Ms.
Sutcliffe stated that they were taken on a tour of the facility.
Ms. Sutcliffe stated that they observed that the pharmacist did not verify each step during the
compounding process.
Ms. Sutcliffe stated that they had 10 random prescriptions/orders pulled from the Arizona report.
Ms. Sutcliffe stated that there were issues with Beyond Use Dates (BUD). Ms. Sutcliffe stated
that there appeared to be issues with the BUD for Trimix. Ms. Sutcliffe stated that they were
placing a 6 month date on Trimix when it was frozen but should have a 1 month date if
refrigerated. Ms. Sutcliffe stated that there was no indication of a BUD recommendation for the
individual components prior to compounding, as Trimix.
Ms. Sutcliffe stated that their sterility testing policies indicate that they follow USP 71. Ms.
Sutcliffe stated that is not what they found when looking at the compounds. Sterility sampling
was not compliant for number of containers/total volume tested.
Ms. Sutcliffe stated that they were inconsistencies in all 10 Arizona records pulled
Ms. Sutcliffe stated that they looked at the Last FDA 483 letter and noted violations. Ms.
Sutliffe stated that they also noted that the sampling plan is not compliant with USP 71
requirements. Ms. Sutcliffe stated that there was a breach of ante room protocol.
Ms. Sutcliffe stated that additional records were obtained and they also contained missing or
incomplete information.
Ms. Sutcliffe stated that the Pharmacy must have an NABP inspection in order to renew their
Texas license. Ms. Sutcliffe indicated that they would be sending a copy of the inspection to the
Board Office.
Dr. Musil asked if they had a current non-resident permit. Ms. Sutcliffe replied yes. Ms.
Sutcliffe stated that a new Pharmacist in Charge started in August. Ms. Sutcliffe stated that the
new pharmacist in charge is aware of the issues but has not been able to implement changes yet.
Mr. McAllister stated that the Board could wait for the NABP inspection or the Board could take
action based on the Compliance Officer’s inspection.
Mr. Kennedy asked how long it would take to schedule the NABP inspection. Mr. McAllister
stated that it could take up to 8 weeks.
Mr. Van Hassel stated that he felt that we should offer a consent based on our findings.
On motion by Mr. McAllister and seconded by Mr. Van Hassel, the Board unanimously
agreed to offer Wells Pharmacy Network a Consent Agreement with the following terms:
1. Reimburse the Board for the Compliance Officer’s trip
2. A civil penalty of $1, 000 dollars for each violation – 9 violations
3. Probation for 1 year. The probation can be ended by passing an inspection by
an Arizona Compliance Officer. The inspection and related costs will be paid
by the Pharmacy. The pharmacy must pass the inspection and then they can
petition the Board for removal of the probation.
A roll call vote was taken. (Ms. Locnikar – aye, Dr. Musil-aye, Mr. Francis- aye, Mr. Van Hassel
– aye, Mr. Minkus- aye, Mr. Kennedy – aye, Mr. McAllister – aye, and Dr. Foy – aye)
Mr. Lee suggested that the Board may also want to offer the Pharmacy a Consent Agreement for
Voluntary Surrender of their license and the Pharmacy could choose which agreement they
would like to sign.
On motion by Mr. McAllister and seconded by Mr. Van Hassel, the Board unanimously
agreed to also offer the Pharmacy a Consent Agreement for Voluntary Surrender of their license.
A roll call vote was taken. (Ms. Locnikar – aye, Dr. Musil-aye, Mr. Francis- aye, Mr. Van Hassel
– aye, Mr. Minkus- aye, Mr. Kennedy – aye, Mr. McAllister – aye, and Dr. Foy – aye)
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