Wednesday, September 17, 2014

Third Question of the Day September 17, 2014 How are non-resident pharmacies doing business in Texas doing with their third-party inspections? Is this just more layers that look good on the surface but really have no impact and instead it is business as usual in Texas?


Observation of the Day: Doing a search on Oklahoma Board of Pharmacy website they show 2428 pharmacy licensed to do business who are non-resident. I am not sure how many of those do sterile compounding but if it is even half that is a lot of pharmacy that will need parenteral permits and an Oklahoma licensed pharmacy manager or PIC.

Total Records:  2428  


Beginning July 1, 2014 there will be a change in the licensing requirements for non-resident pharmacies licensed by the Board that are compounding sterile drug products.  If a licensed non-resident pharmacy is compounding sterile drug products, they must obtain an Oklahoma "Parenteral Permit" in addition to their pharmacy license.
Beginning January 1, 2015 all new and renewal non-resident pharmacy license applications that require a parenteral permit (i.e. pharmacies compounding sterile drug products) will also be required to have an Oklahoma license pharmacy manager or pharmacist-in-charge.

Updated List of Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates U.S. Voluntary Recall of One Lot of Potassium Chloride Injection Due to Shipping Carton Mislabeling

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiates U.S. Voluntary Recall of One Lot of Potassium Chloride Injection Due to Shipping Carton Mislabeling

Second Question of the Day September 17, 2014 Is Senate Bill 2825 a good idea or a bad idea? What are the pros and cons? What is DEA's position on this one? How would this work with the DQSA if it is a compounded preparation that contains a controlled subtance but pharmacists are mass producing the same preparation and sending it to doctors for specific patient? Is this a way for compounded pain pharmacist and doctors to continue to gain mass profits from illegal compounded pain medications?


IACP Successful in Introducing Senate Bill 2825


IACP Successful in Introducing Senate Bill 2825

by iacprx
Working with U.S. Senators John Cornyn (R-TX) and Sherrod Brown (D-OH), theInternational Academy of Compounding Pharmacists (IACP) successfully has introduced legislation that would allow a pharmacist to deliver a controlled substance to a practitioner.
S. 2825 ‘‘Ensuring Safe Access to Prescription Medication Act of 2014’’ is designed to "amend the Controlled Substances Act to treat as dispensing the delivery of a controlled substance by a pharmacy to a practitioner, pursuant to a patient-specific prescription of the practitioner, under certain circumstances."
"This has been a long-term goal of the Academy," said IACP President Pat Stephens, PharmD. "When we established our 2014 legislative agenda in February, resolving the constructive transfer issue once and for all was one of the top three directives we gave our Washington offices. Even while we keep our focus on monitoring the implementation of the Drug Quality & Security Act, IACP continues its work on other critical issues affecting our members."    

Question of the Day September 17, 2014 Now that the FDA has sent its letter to Congress and IACP has its answer regarding office use will it start encouraging or demanding that its members comply with the law as it was written and passed?


Interesting from ScriptsAmerica, Inc.

  1. ScripsAmerica, Inc. (OTCBB: SCRC) today announced that the

    investorshub.advfn.com › ... › ScripsAmerica Inc (SCRC)
    ADVFN
    10 hours ago - Are the referrals for compounded drugs? Or other Rx types? If compounding, we need to see the impact of the new restrictions on insurance coverage that took ...

What's in a Compound? The Question Is More Like, What Isn't? | AIS Health

What's in a Compound? The Question Is More Like, What Isn't? | AIS Health

DEA Offers New Prescription Drug Return Policy Posted on September 17, 2014

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.
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