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Web Sightings
Informative and interesting industry news and views from web sites around the globe.
Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update
On February 18, 2004, FDA issued a Report entitled "Combating Counterfeit Drugs: A Report of the Food and Drug Administration." The comprehensive Report highlights several measures that can be taken to better protect Americans from counterfeit drugs. These measures address six critical areas:
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COMBATING COUNTERFEIT DRUGS
A Report of the Food and Drug Administration
The counterfeiting of currency and consumer products are common problems that plague governments and manufacturers around the world, but the counterfeiting of medications is a particularly insidious practice. Drug counterfeiters not only defraud consumers, they also deny ill patients the therapies that can alleviate suffering and save lives. In some countries the counterfeiting of drugs is endemic -- with some patients having a better chance of getting a fake medicine than a real one. In many more countries, counterfeit drugs are common. In the United States, a relatively comprehensive system of laws, regulations, and enforcement by Federal and state authorities has kept drug counterfeiting rare, so that Americans can have a high degree of confidence in the drugs they obtain through legal channels. In recent years, however, the FDA has seen growing evidence of efforts by increasingly well-organized counterfeiters backed by increasingly sophisticated technologies and criminal operations to profit from drug counterfeiting at the expense of American patients.
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FLORIDA LEGISLATION ON PRESCRIPTION DRUG "PEDIGREES"
Last month, Florida Governor Bush signed prescription drug counterfeiting legislation that toughens the state’s law on “pedigree paper” and other transactions for pharmaceutical wholesalers. Pedigree paper refers to a document, either in paper or electronic form, that contains information that records each distribution of any given prescription drug, from sale by a manufacturer, through acquisition and sale by any wholesaler or repackager, until final sale to a pharmacy or other person administering or dispensing the drug.
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States move to comply with drug pedigree laws
To counter the rise in drug counterfeiting, three states now have prescription drug pedigree laws on their books, another 15 have similar legislation in the pipeline, and the Food & Drug Administration is threatening to enforce its long- dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees by the end of 2006.
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Electronic Authentication of Pharmaceutical Packaging and the Assurance of Public Safety: Position of the Pharmaceutical Research and Manufacturers of America
This White Paper establishes the position of the Pharmaceutical Research and Manufacturers of America (PhRMA) on the use of electronic authentication technologies, such as two-dimensional bar codes and radio-frequency identification (RFID) tags, to secure the U.S. Drug supply against counterfeiting threats. PhRMA issues this White Paper to engage patients, trading partners, state regulatory authorities and the Food and Drug Administration (FDA) in discussions that will lead to a safer and more secure pharmaceutical supply chain.
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Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule
The Food and Drug Administration (FDA) is issuing a new rule
to require certain human drug and biological product labels to have bar
codes. The bar code for human drug products and biological products
(other than blood, blood components, and devices regulated by the
Center for Biologics Evaluation and Research) must contain the National
Drug Code (NDC) number in a linear bar code. The rule will help reduce
the number of medication errors in hospitals and other health care
settings by allowing health care professionals to use bar code scanning
equipment to verify that the right drug (in the right dose and right
route of administration) is being given to the right patient at the
right time. The rule also requires the use of machine-readable
information on blood and blood component container labels to help
reduce medication errors.
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call Optel Vision today at 1-866-688 0334 or 1-418-688 0334.
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September 26-28, 2005
Las Vegas
Booth N-10529
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