About GPhA

For Consumers

Below are additional resources for consumers seeking more information about their medicines, health care services, or other programs.

Centers for Medicare and Medicaid Services (CMS)

Medicare Prescription Drug Coverage Information (CMS)

DrugDigest: An interactive web site that allows consumers to determine whether they could have drug interactions from certain drug combinations.

Be MedWise: An informational web site about the kinds of questions you should ask your doctor before you take medicine.

Frequently Asked Questions About Generic Drugs, FDA web site

FDA and Bioequivalence: FDA's information helps consumers understand that generic medicines must have the same active ingredients and produce the same results in order to receive approval.

SOSRx Coalition: A coalition, of which GPhA is a member, working to make the outpatient use of medicines safer.

National Council on Patient Information and Education (NCPIE): NCPIE is a consumer group that works to advance the safe, appropriate use of medicines through enhanced communication. GPhA is a member.

MedWatch: The FDA's safety information and adverse event reporting program.

Find Your Local Poison Control Center: The American Association of Poison Control Centers provides information on finding your local poison control center.

Resources for Researchers

Below are additional resources to assist researchers gain a better understanding of the generic industry. Please note that some presentations from GPhA events can be found under "Past Meetings."

Patent Expirations

Drugs@FDA: FDA's searchable database of approved medicines. Use this database if you are searching for available generics (and download GPhA's how-to guide).

Anticipated patent expirations through 2010 (listed on page 26 in GPhA's 2008 Annual Report)

FDA Electronic Orange Book: The FDA's official book of approved drugs, which includes patent dates.

FDA First Generics Approval: A posting of the latest medicines approved as generics.

Generic Sales and Prescriptions

Pharmacy Facts and Figures, Drug Topics Magazine: Lists the top brand and generic medicines by retail sales and prescriptions dispensed.

RxList Top 300 Prescriptions Dispensed, 1995-2005

The Generic Approval Process

FDA Drug Applications Site Map: Frequently asked questions and guide to submitting an ANDA or NDA.

FDA's brief background on bioequivalence.

Paragraph IV and 180-Day Exclusivity Issues: FDA's explanation of certain issues regarding patent challenges.

A Look at OGD Applications: Presentation from Gary Buehler, Director of the Office of Generic Drugs, at GPhA's October 2007 Fall Technical Conference. (PDF)

Other Resources

U.S. Pharmacopeia (USP): USP is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards. USP's standards are also recognized and used in more than 130 countries.

National Coordinating Council for Medication Error Reporting and Prevention: An independent body whose aim is to maximize the safe use of medications and to increase awareness of medication errors through open communication, increased reporting and promotion of medication error prevention strategies. GPhA is a member.

Coalition for a Competitive Pharmaceutical Market: A group of large employers, manufacturers, insurers, and others concerned about increasing health care costs.

** GPhA is not responsible for the content of outside web sites.