Wednesday, November 12, 2014

Questions Still Remains About what Georgia Board of Pharmacy Plans to do in Terms of Determining Line Between Five Percent Rule for Compounding and the Broader Use and Distribution from Wholesalers; Current Position is No Anticipatory Compoundng unless you are an Outsourcing Facility

Rule 480-6-.02 Nonresident Pharmacy Permit
Public comments from Jimmy England, Walgreens, were received. Mr. England stated that they would like to see the 72 hours changed to five business days in case it is a holiday weekend. Ms. Wray commented that would require reposting; however, she advised the Board can adopt the rule the way it is currently written and then it can post any changes at a later time. Mr. Miller stated that he feels the Board would support the 72 hours changing to five business days, but feels that the Board should move  forward with adopting the rule today and will go back to amend at a later time.
Public comments from Robert Stannard, BSL, were received.

Mr. Stannard commented on the five percent rule and asked what Georgia intends to do in terms of determining the line between that compounding and the broader use and distribution from wholesaler. He stated there seems to be some question about that on the federal level. Ms. Wray stated that he is referencing 503b outsourcing facilities. Mr. Stannard asked if one were to try and distinguish between an out-of-state compounding pharmacy asking for a permit and a wholesale distributor asking for a license, how is that distinction made? Ms. Wray responded by stating that he will need to seek the advice of an attorney in regards to that matter. Public comments from Carmen Catizone, National Association of Boards of Pharmacy, were received. 
Mr. Catizone stated that they are in almost weekly conversations with the FDA and the current position is there is no anticipatory compounding. An outsourcing facility under 403b and 503b entities will have to register or voluntarily register with the FDA depending on how the state classifies them. The 503b entities cannot engage in wholesale distribution under the law. Mr. Catizone continued by stating any compounding pharmacy, whether it is in-state or out-of-state, that is compounding in anticipation of a prescription, cannot compound those prescriptions to a pharmacy. They will have to be registered or licensed or operate as an outsourcing facility.
Public comments from Wendy Bailey, Peach State Health Plan, were received. Ms. Bailey stated that
her question is concerning the 60 hour per week requirement for pharmacies that are out of state to be open. She asked the Board to clarify whether it means they had to be operating the entire 60 hours, or if they have to have a pharmacist on call to answer questions for patients.
Ms. Wray responded by stating that there have been a lot of questions about the 60 hours. It says a
permit holder shall maintain a toll-free telephone number operational during the permit holder’s regular hours of operation, but not less than six days per week for a minimum of 60 hours per week that shall be used to provide and facilitate patient counseling. Such toll-free number shall be capable of receiving inbound calls fom patients to the permit holder. Ms. Wray stated many comments have been received and people would like for the Board to reduce the hours to 40; however, this is from the law and it cannot be reduced without a legislative change. Ms. Wray  went on to say that she thinks it means it is clearly to facilitate patient counseling and that the toll-free number has to be available the 60 hours per week.
Ms. Wray stated that comments have been received regarding substituting the permit holder pharmacist so that it can be routed out to anybody. She stated that the law says permit holder and the Board copied that verbatim from the law.
Ms. Wray mentioned one other comment spoke to why the pharmacist’s name on the label is required.
Ms. Wray stated that this is in the law. Per O.C.G.A. § 26-4-80(k) states that the pharmacist who fills an outpatient prescription drug order shall indicate the identity of the dispensing pharmacist on the label of the prescription drug.
Written comments were received from the following:
Stephen Georgeson
Peggy Dietrich, RxDirect
John Sisto, Express Scripts
Allen K. Horne, CVS Health
Lynda Chapman
quoted from Georgia Board of Pharmacy September 2014 Minutes

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