Maffeo - Legal and regulatory issues in self-care pharmacy practice




 * 1) Identify legal and regulatory processes and issues that relate to self-care pharmacy practice.
 * 2) Outline three categories that OTC drugs are currently available on the market.
 * 3) Know the FDA labeling requirements for nonprescription medications (i.e. the drug facts label).
 * 4) Describe the three ways drugs can be reclassified from prescription to OTC status.
 * 5) Identify the information considered by the Nonprescription Drug Advisory Committee when deciding prescription to OTC switches (or reclassification).
 * 6) Define the following: reclassification, tamper-evident, tamper resistant, and Behind-the-Counter medications.
 * 7) Understand the differences between tamper-evident and tamper resistant.
 * 8) List the benefits of the availability of self-care products.
 * 9) Identify OTC medications that have Behind-the-Counter or Regulated sales.