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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

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Related Experiment Video

Updated: Jun 24, 2026

Enhanced Cochlear Coverage and Hearing Preservation in High-Frequency Hearing Loss via Electric Acoustic Stimulation with Longer Electrode
03:49

Enhanced Cochlear Coverage and Hearing Preservation in High-Frequency Hearing Loss via Electric Acoustic Stimulation with Longer Electrode

Published on: October 11, 2024

DEA issues proposed rule on e-prescribing.

Frederick R Ball1

  • 1Duane Morris LLP, 227 West Monroe Street, Suite 3400, Chicago, IL 60606, USA. frball@duanemorris.com

The Journal of Medical Practice Management : MPM
|March 18, 2009
PubMed
Summary
This summary is machine-generated.

The Drug Enforcement Administration (DEA) proposed new rules to modernize controlled substance regulations. Electronic prescribing and dispensing aim to improve accuracy and efficiency in handling controlled medications.

Related Experiment Videos

Last Updated: Jun 24, 2026

Enhanced Cochlear Coverage and Hearing Preservation in High-Frequency Hearing Loss via Electric Acoustic Stimulation with Longer Electrode
03:49

Enhanced Cochlear Coverage and Hearing Preservation in High-Frequency Hearing Loss via Electric Acoustic Stimulation with Longer Electrode

Published on: October 11, 2024

Area of Science:

  • Pharmacology
  • Health Law
  • Regulatory Affairs

Background:

  • Current regulations for controlled substances require modernization.
  • Electronic prescribing offers potential for improved accuracy and efficiency.

Purpose of the Study:

  • To discuss the Drug Enforcement Administration's (DEA) proposed rule change.
  • To outline the implications of permitting electronic prescribing for controlled substances.

Main Methods:

  • Review of the DEA's Notice of Proposed Rulemaking published June 27, 2008.
  • Analysis of the proposed amendments to controlled substance regulations.

Main Results:

  • The DEA proposed allowing practitioners to electronically write prescriptions.
  • Pharmacies would be permitted to electronically dispense and archive controlled substance prescriptions.

Conclusions:

  • The proposed rule aims to enhance the accuracy and efficiency of controlled substance management.
  • Electronic prescribing represents a significant modernization of controlled substance regulation.