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Allergan Recalls Sample Packs of Taytulla 1 mg/20 mcg, Due to Out of Sequence Capsules

Posted on Jun 07, 2018

Allergan issued a voluntary recall in the United States market of one lot of Taytulla® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg, 6×28 physicians sample pack. The recalled product, an oral contraceptive indicated for use by women to prevent pregnancy, was distributed to health care providers nationwide. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of Taytulla. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. The affected lot number is 5620706 and has an expiry date of May 2019. Additional details about this recall may be found in the company’s announcement posted to Food and Drug Administration’s (FDA’s) website. Adverse events or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Deadline Nears on Walgreens-Rite Aid Deal

Posted on Jan 25, 2017

Mergers and acquisitions are the norm in the pharmacy world, but several of those appear to be stalled or postponed.  The FTC has yet to approve Walgreens’ proposed acquisition of Rite Aid.  read more

Hospira Recalls One Lot Bupivacaine Hydrocloride Injection, USP

Posted on Aug 18, 2016

Hospira, Inc, of Lake Forest, IL, is voluntarily recalling one lot of 0.25% bupivacaine hydrochloride injection, USP due to the presence of particulate matter within a single vial. The issue was identified through a confirmed complaint. The recall affects National Drug Code number 0409-1159-02 and lot number 59-064-DK with the expiry date of November 1, 2017. The lot was distributed nationwide in the United States to wholesalers and hospitals between December 2015 and January 2016. The product is packaged as 50 units of 30 mL single-use tear-top vials per case (25 bottles per tray, two trays per case). To date, Hospira has not received reports of any adverse events associated with the recall. The press release posted to FDA’s website states that anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Adverse reactions or quality problems may be reported to Food and Drug Administration’s (FDA’s) MedWatch Safety Information and Adverse Event Reporting Program

Teva Recall

Posted on Aug 10, 2016

Teva Pharmaceuticals of North Wales, PA, has recalled seven lots of amikacin sulfate injection, USP, 500 mg/2 mL (250 mg/mL) and 1 gram/4 mL (250 mg/mL) vials because of the potential for the presence of glass particulate matter. Amikacin sulfate injection 250 mg/mL, 2 mL and 4 mL vials were distributed nationwide through wholesalers, retailers, and pharmacies. The specific lot numbers, expiration dates, and national drug code numbers can be found in the recall alert posted to FDA’s website. To date, Teva has not received any reports of adverse events or complaints related to this recall. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Adverse events or quality issues can be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program

Tennessee: HB 1697 to go before Full House on 3/10/2016

Posted on Mar 09, 2016

HB 1697 will go before the Full House in Tennessee’s General Assembly on Thursday, March 10.  It is critical that you contact your State Representative today and encourage him or her to SUPPORT HB 1697. 
In 2014, the General Assembly passed a law to regulate a technique used by Pharmacy Benefits Managers (PBMs) to limit the sums paid to pharmacies which dispense generic drugs to their patients.  The technique involves the establishment of a maximum allowable cost (MAC) for each drug.  The MAC price is the amount paid by a PBM to a pharmacy which dispenses the generic drug.
Before a PBM can establish a MAC price for a particular drug, the PBM must find that the drug is generally available for purchase by pharmacies at or below that price from a national or regional wholesaler.  A pharmacy which believes that a PBM has incorrectly established a MAC price because the drug cannot be purchased at the MAC price is allowed to appeal the determination on that drug through an appeal process established by the PBM.
The current statute (§56-7-3108) states that “a pharmacy may contest the listed maximum allowable cost for a particular drug.”  Pharmacies often utilize an agent to handle all their administrative matters, including MAC appeals.  These organizations are called pharmacy services administrative organizations (PSAOs).
Why Do We Need to Pass HB 1697?
House Bill 1697 adds to the statute a definition of “pharmacy services administrative organization” and provides that a pharmacy has a right to designate a PSAO or other agent to file and handle its appeal of a MAC price established by a PBM for a particular drug.

2016 CMS Part D Prescriber Validation Requirements

Posted on Jan 06, 2016

Effective January 1, 2016, prescriptions will no longer be covered under Medicare Part D if written by a prescriber who does not have a valid Type 1 NPI. When a claim rejects due to an inactive, invalid or missing NPI and cannot be resolved at the point of sale, the pharmacy must provide information to the beneficiary explaining the reason the claim could not be covered under Medicare Part D.
Medicare Part D Plans must reject the claim if:
 Non-NPI is submitted
 Type 1 NPI is inactive
 Invalid NPI is submitted (e.g. Type 2 NPI)
Claims will reject and pharmacies can no longer use the submission clarification code (SCC) 49 – “Type 1 NPI unavailable” to communicate with the plan sponsor. SCC 42 – “Submitted Prescriber ID is Active and Valid with Appropriate Prescriptive Authority” will be permitted.
In the event a claim rejects for invalid Prescriber ID, please review the following steps.
 Verify the submitted NPI is a Type 1 – Individual. If the Prescriber’s NPI is not a type 1, call the Prescriber to obtain the individual Prescriber NPI.
 Validate the NPI online by using the CMS NPI checker: https://nppes.cms.hhs.gov/NPPESRegistry/NPIRegistryHome.do
Please note – For controlled substance prescribing, a prescriber must have an active DEA identifier in good standing and have the authority to prescribe a controlled substance in a given DEA drug class schedule (2, 2N, 3, 3N,4, and 5), but the appropriate SCC value can be used to override the rejection. You can
You can validate a Prescriber’s DEA at https://www.deadiversion.usdoj.gov/webforms/validateLogin.jsp.