Content about Regulatory and Washington

March 18, 2014

Avella Specialty Pharmacy announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act.

March 18, 2014

The Consumer Healthcare Products Association this year will be focusing on restoring OTC eligibility under flexible spending accounts and helping to finalize OTC monographs, Scott Melville, CHPA president and CEO, told attendees of the 2014 CHPA Annual Executive Conference Tuesday morning.

March 17, 2014

Abbott voluntarily recalled the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter, neither of which have been in production since 2010.

March 17, 2014

New York Attorney General Eric Schneiderman on Monday joined Ohio Attorney General Mike DeWine in leading an effort to persuade the largest pharmacy chains in the United States to stop selling tobacco products.

March 17, 2014

An educational briefing, “Widespread Nutrient Shortfalls: A Public Health Crisis?” was held for Capitol Hill staffers Friday by the Congressional Dietary Supplement Caucus, in cooperation with the leading trade associations representing the dietary supplement industry — the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.

March 17, 2014

The legislature is mulling a bill that would alter the structure of Florida’s Board of Pharmacy, raising from one to three the number of seats for pharmacists representing both smaller and larger pharmacies, according to the Associated Press.

March 14, 2014

In a statement, HDMA president and CEO John Gray said the national association representing primary healthcare distributors applauds U.S. Attorney General Eric Holder's weekly address concerning the nation's prescription drug abuse epidemic.

March 14, 2014

Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

March 14, 2014

The Federal Trade Commission is holding a public workshop in March to examine U.S. healthcare competition issues as healthcare spending swallows up a significant part of federal and state budgets. Among the topics up for discussion, according to reports, are retail clinics and telemedicine.

March 13, 2014

The American Association of Nurse Practitioners, a national professional membership organization for nurse practitioners of all specialties, is calling on state lawmakers to consider the consequences of undue restrictions on APRNs, or nurse practitioners, as recommended by the Federal Trade Commission.

March 12, 2014

Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

March 11, 2014

The Centers for Medicare and Medicaid Services has decided not to move forward on several of the proposed provisions of the Medicare Advantage and Part D prescription drug program, according to reports.

March 11, 2014

Bipartisan legislation that would designate pharmacists as healthcare providers under the Medicare program was introduced in the U.S. House of Representatives on Tuesday. The bill would amend The Social Security Act of 1935 to enable pharmacists to work to their full capability by providing underserved patients in the Medicare program with services not currently available to them.

March 10, 2014

The majority of pediatric bacterial infections that cause severe diarrhea and are potentially life-threatening occur among children who recently took antibiotics prescribed by doctors for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

March 10, 2014

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy.

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 7, 2014

A study published online Friday shows that the omega-3 fatty acids EPA and DHA — commonly found in fatty fish and fish oil supplements — are as effective, if not more effective, in lowering blood pressure as some of the commonly recommended lifestyle changes like increasing physical activity and restricting alcohol and sodium intake.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

March 6, 2014

Could retail-based health clinics be coming soon to Boston? While it appears that there are no definite plans in the works, a spokeswoman for Mayor Martin J. Walsh reportedly said that he has no intention of blocking the clinics from coming to Boston, the Boston Herald reported.

March 6, 2014

The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post.

March 5, 2014

Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

March 5, 2014

In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for health of the Department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.

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