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Saturday, January 26, 2013

New Legislation Proposed In Oklahoma: But What's The Point Without More Inspectors and Actual Enforcement?


State Senator and compounding pharmacist Rob Standridge pre-filed SB 522 bill in the Oklahoma Senate.  SB 522 as written provides: 


STATE OF OKLAHOMA
1st Session of the 54th Legislature (2013)
SENATE BILL 522 By: Standridge
AS INTRODUCED
An Act relating to nonresident pharmacies; requiring 
nonresident pharmacies to submit certain information 
in applications for license issuance or renewal; 
providing for certain fees; providing for 
codification; and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1.     NEW LAW     A new section of law to be codified 
in the Oklahoma Statutes as Section 355.3 of Title 59, unless there 
is created a duplication in numbering, reads as follows:
As used in this act:
1.  "Nonresident pharmacy" means any pharmacy located outside of 
this state which delivers, dispenses, or distributes by any method 
prescription drugs or devices to a user physically located in this 
state, in addition to the initial application or renewal form and 
other documents required for a pharmacy located in Oklahoma; and
2.  "Pharmacist-in-charge" means a professionally competent, 
legally qualified pharmacist responsible for compliance with all Req. No. 367 
Page 2
laws and regulations governing the operation of the respective 
pharmacy.
SECTION 2.     NEW LAW     A new section of law to be codified 
in the Oklahoma Statutes as Section 355.4 of Title 59, unless there 
is created a duplication in numbering, reads as follows:
A nonresident pharmacy, in addition to the initial application 
or renewal form and other documents required for a pharmacy located 
in Oklahoma, shall:
1.  Submit an affidavit signed by the pharmacist-in-charge that 
the pharmacy shall comply with non-sterile and sterile compounding 
standards of the newest edition of the United States Pharmacopeial 
and United States Food and Drug Administration Good Manufacturing 
Practices;
2. a. Submit a pharmacy site inspection form completed and 
signed within the previous eighteen (18) months by a 
person authorized by the pharmacy's resident state 
agency or board which is responsible for issuing 
pharmacy licenses,
b. Submit a pharmacy site inspection form completed and 
signed within the previous eighteen (18) months by a 
staff person employed by the Oklahoma State Board of 
Pharmacy and pay all costs incurred by the Board for 
completion of the inspection, orReq. No. 367 
Page 3
c. Submit an inspection report or certificate of 
approval, from an organization approved by the 
Oklahoma State Board of Pharmacy, which shall include 
the standards and procedures to which the pharmacy 
demonstrated compliance; and
3.  Pay an additional fee of One Hundred Dollars ($100.00) over 
and above the licensing and inspection fees charged to in-state 
pharmacies to cover the additional costs associated with 
administrative review and consideration of documents listed in 
subparagraphs a, b and c of paragraph 2 of this section.
SECTION 3.  This act shall become effective November 1, 2013.
54-1-367 JAM 1/25/2013 11:43:36 AM


The pre-filed bill would require non-resident pharmacies to complete an affidavit stating their compliance with USP standards and FDA Good Manufacturing Practices. Additionally, non-resident pharmacies would need to submit current inspection reports from their home state Board of Pharmacy and pay an additional fee for renewal.

While Standridge's bill is a start even if passed it will serve no purpose if there are not more and better inspections and enforcement of the laws and regulations.  Anyone can sign an affidavit stating compliance with USP standards and FDA Good Manuafacturing Practices.  What are the consequences for signing such an affidavit if it is false?  And how does it work when the inspection in another state is based on different standards and laws than those in the state of Oklahoma?  No problem if the other states' standards are higher, or is there?  There is definitely a problem if the other state has  lower inspection standards?  Can you never do business in Oklahoma again if you submit a false affidavit?  The bill provides no fine or consequences for failure to comply with the provisions.  And is $100.00 really enough of an additional fee to charge out of state pharmacies who do business here?   The bill provides for no additional funding at the Oklahoma State Board of Pharmacy. This also is another example of how complex and complicated the patchwork legislation can be for pharmacies to comply with in all states.   This proposed legislation maybe a start in Oklahoma but is by no means a solution to the problems in the compounding world.

As note that Oklahoma State Senator Bingman has written Senate Bill 250, addressing workers compensation program reimbursement whereby compounded medications would be paid by the state's worker's compensation court at the rate of ingredient costs plus a $5.00 dispensing fee. Senate Bill 250 is a companion bill to pre-filed legislation in the Oklahoma House -- HB 1546.






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