[DOC] [TLE] Over-the-counter drug - Wikipedia [PAR] Over-the-counter (OTC) drugs are medicines sold directly to a consumer without 
a prescription ... These drugs are kept in an area of the retail outlet where self-
selection is ... but the act exempts any drugs generally recognized as safe and 
effective ... The FDA requires that OTC products are labeled with an approved "
Drug... [DOC] [TLE] Prescription drug - Wikipedia [PAR] A prescription drug is a pharmaceutical drug that legally requires a medical 
prescription to be .... Often a lower strength of a drug will be approved for OTC 
use, whereas higher ... prescribe drugs for uses other than those specified in the 
FDA approval; this is .... Jump up ^ "Drug Expiration Dates - Are They Still Safe to 
Take? [DOC] [TLE] Development & Approval Process (Drugs) > Orange Book ... - FDA [PAR] The publication, Approved Drug Products with Therapeutic Equivalence ... 
existing OTC monographs; (3) drug products with approval under Section 505 of 
the ... are approved as safe and effective; (2) they are pharmaceutical equivalents 
in .... the in vivo determination of bioequivalence is self-evident and a waiver of 
any in... [DOC] [TLE] Development & Approval Process (Drugs) > National Drug ... - FDA [PAR] Jun 14, 2012 ... What are the NDC Number and the National Drug Code Directory? ... The current 
edition of the NDC Directory is limited to prescription drugs, OTC drugs, and 
insulin ... are generally supplied by the manufacturer (also called labelers or ... 
drug is safe and effective for use under the conditions prescribed,... [DOC] [TLE] 21 CFR Part 334 - FDA [PAR] the-counter (OTC) laxative drug ... safe and effective and not misbranded. ... part 
of the ongoing review of OTC drug .... monograph the abbreviation gm is ... 
through self-medication, the comments ..... recognized that some of the so-called. [DOC] [TLE] Oral Health Care Drug Products for Over-the-Counter Human ... - FDA [PAR] May 29, 2003 ... ongoing review of OTC drug products. ... safe and effective or would result in .... 
an approved new drug application ..... may be self-diagnosable because people 
... is termed marginal gingivitis and occurs ..... stand alone. 2. [DOC] [TLE] OTC Status for Low-Dose Lovastatin Would Have Widespread ... [PAR] The FDA stands poised to approve OTC low-dose statins, following a similar 
change ... Food and Drug Administration consideration of switching the status of 
the .... a degree that would satisfy the FDA, Merck conducted an unusual study, 
called a ... drug fits well into the self-management profile required of OTC 
medications. [DOC] [TLE] Over-The-Counter Drugs: A Dangerous Prescription For Confusion ... [PAR] Feb 4, 2014 ... Shopping for medicine can become bewildering, as pharmaceutical companies 
... Efforts to stop using the abbreviation are currently underway. ... People have 
the impression that if a drug is approved for over-the-counter use, then it .... 
prescription drugs OTC under certain so-called conditions of safe use. [DOC] [TLE] Use, Abuse, Misuse & Disposal of Prescription Pain Medication ... [PAR] As the leader for the specialty of Preventive Medicine and physicians dedicated 
to ... Abuse: Self-administration of medications to alter one's state of .... About 1 in 
20 abuse Oxycontin; Prescription and OTC medications account for 8 of the 14 .... 
FDA approval of drugs as safe and efficacious with precautionary "black box... [DOC] [TLE] A. Background to the Durham-Humphrey Amendments [PAR] However, the 1962 Drug Amendments expanded the FDA's power regarding Rx 
to .... among many other changes, required the FDA to approve all new OTC 
drugs and .... many drugs that were safe for self-medication as prescription-only 
because ...... In fact, the Director of one Office of Drug Evaluation called Dr. 
Galson's... [DOC] [TLE] a critical investigation of the impact of labeling and advertising on ... [PAR] In the early 1970's, the Food and Drug Administration (FDA) launched an Over- 
the-Counter (OTC) Drug Review with the objective of creating

Question: Drugs that the FDA approves as safe for self-medication are termed "OTC", which stands for this
Answer: Over-the-Counter