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Principles for Drug Safety

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Every consumer should feel secure the medicines they purchase are of the highest quality. Drug safety can be compromised by taking medications past the expiration date or if they are stored or handled improperly. Imitations of FDA approved drugs could be contaminated with harmful or unsafe materials. Counterfeits might contain non-standard amounts of active ingredients that affect the integrity of the medication.

The Partnership for Safe Medicines has developed the following principles to support quality assurance programs and establish a drug distribution system that is without compromise.

Protect Our Supply Chain

  • We believe there is strong need for strict, rigorous regulatory oversight of imported pharmaceuticals, including the regulation of the storage throughout the distribution system of imported pharmaceuticals.
  • We support a dramatic and sustained increase in funding for the FDA in order to increase inspections of foreign facilities that manufacture drug products or components of drug products sold in the United States. Additionally, the FDA should be empowered to inspect distribution facilities.
  • We endorse establishing permanent FDA field offices in China, India and other key exporting countries staffed with both inspectors and criminal investigators.
  • We advocate the development and implementation of a standardized drug pedigree program at a national level.

Regulate Online Drug Sellers

  • We value the rigorous oversight and standards that govern traditional pharmacies in the United States and believe all online drug sellers should be held to the same standards.
  • We endorse the full Verified Internet Pharmacy Practice Site (VIPPS) accreditation program created by the National Association of Boards of Pharmacy.
  • We believe all Internet drug sellers, regardless of which state or country they are based in, must comply with the pharmaceutical licensing and survey requirements for every state they sell pharmaceuticals.
  • We advocate that no one should be able to purchase prescription drugs, including controlled substances, over the Internet without a valid prescription and physician oversight.

Unify in the Fight Against Counterfeit Drugs

  • We believe the United States needs to be a leader in the global fight against counterfeit drugs.
  • We recognize that counterfeit drugs, tainted medicines, and rogue online drug sellers are a global problem that requires an international solution.
  • We advocate for international cooperation between government agencies around the world in order to prosecute the unscrupulous counterfeiters who do not hesitate to use foreign, even toxic, materials in their products.
  • We support increasing criminal penalties against the perpetrators of counterfeit medicines to reflect the gravity of their offenses.
  • We endorse granting the FDA authority to destroy unapproved drugs entering the United States rather than returning them to the criminals who sent them here.

pdficon_small Download your own copy of Principles for Drug Safety.

Read about the International Principles for Drug Safety