UPS pays $40M to end online pharmacies probe By PAUL ELIAS - Associated Press Friday, Mar. 29, 2013 | 10:44 AM Read more here: http://www.fresnobee.com/2013/03/29/3235552/ups-pays-40m-to-end-online-pharmacies.html#storylink=cpy

SAN FRANCISCO -- Shipping company UPS has agreed to pay $40 million to end a federal criminal probe connected to its work for online pharmacies.

The U.S. Department of Justice announced Friday that the Atlanta-based company would also "take steps" to block illicit online drug dealers from using their delivery service.

The DOJ says the fine amount is the money UPS collected from suspect online pharmacies.

UPS won't be charged with any crimes. Its biggest rival, FedEx Corp., has also been a target of the federal investigation.

The investigation of the two companies stems from a global campaign to shutter illicit online pharmacies launched in 2005. Since then, dozens of arrests have been made and thousands of websites closed worldwide as investigators continue to broaden the probe beyond the operators.

Read more here: http://www.fresnobee.com/2013/03/29/3235552/ups-pays-40m-to-end-online-pharmacies.html#storylink=cpy

The FDA BLog has a must read--Disclosures in a Small Space: The FTC’s Revisions to .Com Disclosure

 Katie Bond –

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Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones had not yet met the internet and social media barely existed.  In the new version of the guide, updated recommendations and new examples focus on how to craft disclosures given the smaller screen sizes of smartphones as compared to computers and the character and space limitations of most social media (e.g., the 140-character limit for Twitter tweets).

Clear & Conspicuous Requirement.  Under the FTC Act, if a disclosure is necessary to prevent a claim from being deceptive, then the disclosure must be “clear and conspicuous.”  The revised guide, like the 2000 version, continues to emphasize that advertisers should consider the following factors in determining whether an online disclosure is clear and conspicuous:

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FDA cites contamination issues in Delta compounding phamacy Mississippi State strengthening safety requirements

In the wake of contaminated steroid shots at New England Compounding Center linked to a deadly meningitis outbreak, the Food and Drug Administration has discovered problems at a Mississippi Delta compounding pharmacy.

Mississippi is now strengthening safety requirements. “We’re beefing up our compounding rules,” said Frank Gammill, executive director for the state Board of Pharmacy.

The FDA has accelerated inspections of compounding facilities across a dozen states. Last month, it visited the Cleveland facility run by the Illinois-based PharMEDium and reported that procedures designed to prevent contamination of drug products failed to include adequate validation of the sterilization process.

PharMEDium officials say patient safety is their highest priority and that none of the company’s products has been linked to a patient’s death. The New England center’s contamination is linked to 50 deaths.

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RI Compounding Issues Involved:: HEALTH Director Fine Denies License Restoration for Pharmacist Leo Blais' pharmacist license was reinstated just two days earlier, with restrictions. By Lauren CostaEmail the authorMarch 28, 2013

  

The RI Dept. of Health announced Monday the restoration of former state Sen. Leo Blais' pharmacist license, but with stipulations. Just two days later, HEALTH Director Michael D. Fine denied the restoration.

Last March, Director Fine suspended Blais' license indefinitely after a "dispensing error" at his East Greenwich pharmacy, Apothecare Compounding Solutions, resulted in a 2-year-old and an 11-month-old receiving multiple unintended doses of morphine.

The Dept. of Health also cited Blais for removing drugs from his pharmacy, to an unlicensed and unauthorized location during the RI flood event of 2010, as well as compounding prescription drugs in an environment not meeting standards; both allegations that he disputes. 

It was the third time he had disciplinary action taken against him; once in 1999 and again in 2007. 

Last Friday, Blais accepted a court-ordered two-year suspension retroactive to March 23, 2012, with the second year of suspension stayed. His license was on probation during the second year and he was also forbidden from serving as a Pharmacist-in-Charge or an instructor during that period of time. Blais was also required to undergo 40 hours of training; 20 in the areas of law and ethics and 20 in the area of compounding.

In a letter sent to Administrative Hearing Officer Catherine Warren on Wednesday afternoon, Fine said he "disapproved of the Consent Order ratified by the Rhode Island Board of Pharmacy" that allowed Blais his license back.

According to the Health Dept., Fine took this action under the authority of Rhode Island General Law Chapter 5, Section 19.1-5, which requires all board actions to be approved by the director.

“After reviewing the Consent Order ratified by the Board of Pharmacy, I consider the agreement between the parties outlined in the order to be insufficient, given the facts leading to the Summary Suspension of Leo Blais,” Director Fine said. 

Click here to learn about a Barrington couple outraged at the license reinstatement order after Blais administered mislabeled morphine to their 11-month-old daughter.

Source found here

NABP Reports 2012 Year-End Clearinghouse Totals: 4,223 Disciplinary Actions Reported by State Boards of Pharmacy

NABP’s 2012 year-end
data results show a total of
4,223 disciplinary actions
reported by the state boards
of pharmacy to the NABP
Clearinghouse. Of the
4,223 actions reported, 61%
were actions taken against
pharmacists and 39% were
actions taken against pharmacy
technicians.

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NABP 2013 Newsletter Points Out Difficult Legal and Practicual Challenges for Boards of Pharmacy Created by Interstate and International Business

Subpoena Knows No Borders
By Dale J. Atkinson, JD
Advancements in technology increase
the likelihood of licensees practicing
across state and international lines.
As has been emphasized in previous
Newsletter articles, and in a feature
article in this issue, physical presence
is not necessarily a prerequisite to
practice. That is, practitioners can use
technology to render services within
the scope of practice as defined without
stepping foot within the jurisdiction
where the patient is located. Practice
without physical presence creates
difficult legal and practical challenges
for boards of pharmacy. The courts are
currently, and will continue to grapple
with jurisdictional issues involving what
board and/or court has the authority
to adjudicate administrative disputes.
Further, the investigative processes will
also be challenged regarding the gathering
of relevant information to pursue
administrative prosecution. Consider the
following.
A physician (Licensee)
is licensed in both Kansas
and Missouri. In 2009, the
Kansas State Board of Healing
Arts (Board) opened an
investigation of the Licensee
based upon information
that a patient filed a lawsuit
alleging medical negligence,
fraud, and misrepresentation.
The lawsuit was filed
in Missouri based upon the
fact that the medical services
were rendered in Missouri.
The Board issued a subpoena
to the Licensee requesting
documents related to the
medical treatment of the
patient. The Board took
the position that it had the
authority to investigate the
Licensee’s practice and issue
the subpoena because the Licensee
holds a Kansas license
and the allegations in the
Missouri lawsuit constituted
grounds for discipline under
the Kansas Healing Arts Act.
The Licensee filed a petition
in district court seeking
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NOTE:  That each states law is different as to these types of issues and that one state's law is not binding on another state, but is merely persuasive authority.

The April 2013 NABP Newsletter is Jam Packed With Compounding News

To read click here

NABP TO OFFER--Compounding Pharmacy Information Sharing Network Available to Boards Soon Data on Preparation of Patient-Specific Drugs and Non-Patient- Specific Drugs to Be Included

For more information click here

Question of the Day: Are Compounding Pharmacists Being Unfairly Treated in the Press?

Lobbyists weigh in on pharmacy oversight

4 hours ago by editor 0

By Kimberly Kindy and Lena H. Sun

Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.

Commercial drug makers are also pressing a lobbying campaign aimed at stopping these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.

This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.

Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations have begun pressing their own interests along a wide front.

Veterinary groups, for instance, have launched their own lobbying campaign opposing the drugmakers. These groups warn that any legislation that required patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.

Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.

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