11/7/08 - FDA Issues Final Rule Requiring Toll-Free Number on Medication Labeling (Compliance date - July 1, 2009)
Food and Drug Administration (FDA) has issued a final rule requiring the labeling for certain medications to include a toll-free number for patients to report side effects. The final rule confirms the interim final rule “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products” and its requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. The statement must include a toll-free number and advise that the number is to be used only for reporting side effects and is not intended for medical advice. This final rule also affirms the interim final rule’s addition of a new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Food and Dug Administration Amendments Act of 2007. The final rule is effective November 28, 2008, and the compliance date is July 1, 2009. More information is available in the Federal Register [Docket No. FDA–2003–N–0313].

 

10/7/08 - Internet Pharmacy Bill Cleared for White House
The Senate passed legislation that will target illegal online pharmacies and protect patients’ ability to fill legitimate prescriptions online. Illegal online sites lure consumers into schemes to obtain prescription drugs without a prescription or a valid patient-prescriber relationship. Often these sites sell unapproved, counterfeit, mislabeled, or adulterated drug products. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, H.R. 6353, is designed to curb these rogue websites and prevent them from selling controlled substances.

 

10/7/08 - Congress Sends to the President PSE Logbooks Bill
The House approved by unanimous consent the Senate-passed version of S. 1276, the Methamphetamine Production Prevention Act. The bill would provide flexibility to pharmacies to use existing systems to comply with differing federal and state requirements to track the sale of products containing pseudoephedrine.

 

8/26/08 - Governor Kaine Proposes Decrease in Medicaid Dispensing Fees for 2010 Fiscal Year
As part of a $17 million cost-savings package, Governor Kaine will propose a decrease in Medicaid dispensing fees from $4.00 to $3.75. This reduction would go into effect in July, 2009 as part of the State’s Fiscal Year 2010 budget. There would be no reduction in FY 2009.

The 25 cent decrease would be limited to fee-for-service and would not apply to Medicaid managed care plans. The total State General Fund savings as a result of this change is estimated to be approximately $460,000. The total impact on Virginia pharmacies is estimated to be approximately $920,000, which includes federal matching funds for Medicaid.


Additional information will be released as this situation develops.

 

7/1/08 - Pharmacists and Technicians Are Encouraged To Share Their Experiences with Electronic Prescribing on New NASPA/SureScripts Online CQI Portal
NASPA and SureScripts have announced a collaborative effort to gather direct input from practicing community pharmacists and technicians about the experiences that they have had with electronic prescriptions.