12/17/2019	09/13/2019	Dercher Enterprises, Inc., DBA Gordon Laboratories	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
12/17/2019	09/26/2019	LNK International, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
12/17/2019	11/06/2019	Unipharma, LLC	Office of Pharmaceutical Quality Operations, Division II	CGMP/Finished Pharmaceuticals/Adulterated

Importation of Prescription Drugs - InsuranceNewsNet

Importation of Prescription Drugs - InsuranceNewsNet: Agency: ' Food and Drug Administration, HHS.' SUMMARY: The Food and Drug Administration is proposing to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. DATES: Submit either electronic or written comments on the proposed rule by March 9, 2020.

Former NECC pharmacists avoid prison time in prescription medication scheme

https://www.wcvb.com/article/former-necc-pharmacists-avoid-prison-time-in-unrelated-prescription-scheme/30316257#

Tampa marketing firm owners sentenced to federal prison for $60M kickback scheme involving MacDill residents and workers

https://www.bizjournals.com/tampabay/news/2019/12/23/tampa-marketing-firm-owners-sentenced-to-federal.html

The debate over America’s drug-pricing system is built on myths. It’s time to face reality By MATTHEW HERPER @matthewherperDECEMBER 23, 2019

https://www.statnews.com/2019/12/23/debate-over-us-drug-pricing-system-time-to-face-reality/

49 monthly - PacerMonitor

https://www.pacermonitor.com › public › filings › DHCOFBVI › USA_v_...

4 hours ago - 139.2 - Filed 11/02/2018: Exhibit Exhibit B - Interview of Doyle Beach, - 

West Virginia pharmacy pleads guilty to money laundering ...

https://woay.tv › west-virginia-pharmacy-pleads-guilty-to-money-laundering

11 hours ago - (AP) — A West Virginia pharmacy has pleaded guilty to a money laundering ... to dispense compound opioids that were not for legitimate medical purposes,

Additional Clarification from the Oklahoma State Pharmacy Board Regarding the New OSBP Statute

Additional Clarification on NEW OSBP Statute:

59 O.S. § 353.20.2(D): Upon receipt of a valid Schedule II opioid prescription issued pursuant to the provisions of Section 2-309I of Title 63 of the Oklahoma Statutes, a pharmacist shall fill the prescription to the specified dose, and shall not be permitted to fill a different dosage than what is prescribed.  However, the pharmacist maintains the right not to fill the valid opioid prescription.

In response to the concerns expressed by several pharmacists across the State of Oklahoma further discussions were held between OSBP staff and legal counsel.  As a result of those talks it was determined that:

• The Oklahoma State Board of Pharmacy has responsibility for the enforcement, application, and interpretation of this statute.
• Furthermore, in an effort to promote, preserve, and protect the public health, safety, and welfare, the Oklahoma State Board of Pharmacy has determined that the terms “specified dose” and “different dosage” do not apply to the specific quantity dispensed pursuant to a Schedule II opioid prescription. 

 In order to dispense a lesser than prescribed quantity, a new prescription is not required.

FDA Continues to Address Antiparasitic Resistance in Livestock and Horses

The U.S. Food and Drug Administration continues to work with stakeholders to address antiparasitic resistance in livestock (cattle, sheep, goats, swine, and poultry) and horses. In an on-going effort to help maintain the effectiveness of approved antiparasitic drugs, the FDA has produced two videos on antiparasitic resistance; released the results of a survey of the U.S. veterinary community about antiparasitic drug use and antiparasitic resistance in grazing animals; and asked animal drug companies to add information about antiparasitic resistance to the labels of all approved antiparasitic drugs for livestock and horses.

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FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in 2013. Although compounded drugs can fill an important role for patients and the FDA recognizes the need to preserve access to these products, they may also present a greater risk to patients because, among other things, they are not required to...

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