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orthotics
See over-the-counter (OTC) drugs Federal Regulation of Medications: Development, Production, and Marketing See over-the-counter (OTC) drugs Use and Disclosure of PHI; Right to Access
See opioid treatment programs (OTPs) Issuance of Prescriptions Methadone Opioid Treatment Programs Preface Purpose of a Controlled Substance Prescription See opioid treatment programs (OTPs) The Closed System of Controlled Substance Distribution Treatment of Addicts Outside of OTPs
outcomes, regulations for
over-the-counter (OTC) drugs advertising and promotion child-resistant containers defined, Durham-Humphrey Amendment (1951) emergency contraception labeling regulations methamphetamine manufacture new drug approval (NDA) prescription drug vs. product tampering review of Use and Disclosure of PHI; Right to Access
own use doctrine
package insert, prescription drugs federal regulations Pharmaceutical Manufacturers Association v. Food and Drug Administration pharmaceutical manufacturers association V. food and drug administration - pharmaceutical manufacturers association V. food and drug administration proposed electronic distribution of ramon V. farr (1989) - Ramon V. Farr REMS
packaging regulations
pain medication, prescription validity
pain medication addition, duty to intervene
parallel track policy
Park Doctrine
Parker v. Yen (1991)
partial fills, prescriptions Dispensing of Schedule II Controlled Substances Dispensing of Schedule III, IV, and V Controlled Substances
patents Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984 issues
Patent Term Restoration Act (PTRA)
patient authorizations drug information website for consumers and health professionals drug information website for pharmacists information and Medication Guides Patient Package Inserts patient package inserts prescription drug labeling information for
patient counseling and patient information
patient package inserts
Patient Protection and Affordable Care Act of 2010 (ACA) Expedited Approval of Drugs Intended to Treat Serious or Life-Threatening Illnesses ("Fast Track Approval") (§ 506) FDA Safety and Innovation Act of 2012 Medicare Part D
Patient Safety Act
Patient Safety and Quality Improvement Act of 2005
patient safety organizations (PSOs)
patient safety work product (PSWP)
Patterson Drug Co. v. Kingery (1969)
pay for delay agreements
See prescription benefit managers (PBMs) Federal Antitrust Laws Fourteen-day Dispensing Cycle Medicaid Medicare Part D Overview of Important Developments in Medicaid and Prescription Drug Reimbursement Preface Regulation of Managed Care Plan Formularies/Drug Pricing See prescription benefit managers (PBMs) State Legislative Efforts to Regulate Third-Party Plans State Regulation of Third-Party Plans The Sherman Antitrust Act
See Prescription Drug Marketing Act of 1987 (PDMA) Drug Supply Chain Security Federal Regulation of Medications: Dispensing Historical Overview of the Federal Food, Drug, and Cosmetic Act Importation of Prescription Drugs for Personal Use Kennedy v. Kentucky Board of Pharmacy Penalties Prescription Drug Marketing Act of 1987 Prescription Drug Marketing Act of 1987 See Prescription Drug Marketing Act of 1987 (PDMA)
See Prescription Drug User Fee Act of 1992 (PDUFA) FDA Reauthorization Act of 2017 FDA Safety and Innovation Act of 2012 Food and Drug Administration Amendments Act of 2007 Food and Drug Administration Modernization Act of 1997 Historical Overview of the Federal Food, Drug, and Cosmetic Act Medical Device User Fee and Modernization Act of 2002 New Drug Approval Preface Prescription Drug User Fee Act of 1992 See Prescription Drug User Fee Act of 1992 (PDUFA) The Road to an Approved New Drug Application
Pearson v. Shalala (1999)