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Drug Control Laws and Regulations
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Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Purpose: To regulate online pharmacies and prevent the illegal distribution of controlled substances. Enforcement Methods: DEA licensing for online pharmacies, penalties for illegal sales, prescription requirements.
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Purpose: To streamline the process for generic drug approval and extend patent terms for innovator drugs. Enforcement Methods: Provides framework for generic approvals, patent litigation, exclusivity periods.
Secure and Responsible Drug Disposal Act of 2010
Purpose: To reduce prescription drug abuse by allowing for safe disposal of medications. Enforcement Methods: Drug take-back programs, regulations for collection sites, DEA oversight.
Orphan Drug Act of 1983
Purpose: To encourage the development of treatments for rare diseases by providing financial incentives. Enforcement Methods: Granting market exclusivity, tax credits for research, FDA assistance.
Comprehensive Drug Abuse Prevention and Control Act of 1970
Purpose: To consolidate various laws controlling drug abuse and to enhance enforcement measures. Enforcement Methods: Establishing treatment programs, rehabilitation, enforcement of drug policies.
Prescription Drug Marketing Act of 1987
Purpose: To prevent the diversion of prescription drugs from legitimate commercial channels. Enforcement Methods: Restricting drug samples, regulating wholesaling, licensing requirements.
Drug Quality and Security Act (DQSA) of 2013
Purpose: To clarify compounding pharmacy practices and establish a uniform system for tracking pharmaceuticals through the supply chain. Enforcement Methods: New compounding pharmacy standards, track and trace system, FDA oversight.
Federal Food, Drug, and Cosmetic Act (FDCA)
Purpose: To ensure the safety and efficacy of drugs, medical devices, and food. Enforcement Methods: FDA regulation, inspections, product recalls.
Combat Methamphetamine Epidemic Act of 2005
Purpose: To combat methamphetamine abuse by regulating the sale of precursor chemicals. Enforcement Methods: Sales logs for pseudoephedrine, storage requirements, purchase limits.
Drug Addiction Treatment Act of 2000 (DATA 2000)
Purpose: To expand the clinical context for the treatment of opioid dependency with medications. Enforcement Methods: Training and certification of physicians, FDA oversight, counselling requirements.
Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012
Purpose: To give the FDA tools to ensure the safety and efficacy of medicinal products and to expedite their availability to the public. Enforcement Methods: User fee programs, enhanced authority for safety, accelerated approval processes.
Drug Supply Chain Security Act (DSCSA) of 2013
Purpose: To protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Enforcement Methods: Tracking and tracing of pharmaceuticals, verification mechanisms, enhanced record-keeping.
FDA Amendments Act of 2007
Purpose: To give the FDA new authority to regulate the safety of prescription drugs, including post-market surveillance. Enforcement Methods: Risk Evaluation and Mitigation Strategies (REMS), post-market study requirements, new labeling authority.
Anabolic Steroid Control Acts
Purpose: To prevent abuse of anabolic steroids and classify them as controlled substances. Enforcement Methods: Restricting sales, prosecuting illegal distributors, amending the CSA.
Drug Enforcement Administration (DEA)
Purpose: To enforce the controlled substances laws and regulations in the United States. Enforcement Methods: Drug scheduling, raids and arrests, monitoring of pharmaceuticals.
Antitampering Act
Purpose: To prevent tampering with consumer products, including over-the-counter medications. Enforcement Methods: Tamper-evident packaging requirements, criminal penalties for tampering, FDA enforcement.
Generic Drug Enforcement Act of 1992
Purpose: To increase the penalties for fraudulent activities related to generic drug approval. Enforcement Methods: Disqualification of noncompliant companies, fines and imprisonment for offenses, FDA enforcement.
Controlled Substances Act (CSA)
Purpose: To regulate the manufacture, importation, possession, use, and distribution of certain substances. Enforcement Methods: Drug Scheduling, DEA enforcement, penalties for non-compliance.
Poison Prevention Packaging Act of 1970
Purpose: To prevent accidental poisoning in children through the use of safe packaging. Enforcement Methods: Standards for packaging, compliance checks, fines for non-compliance.
Ensuring Patient Access and Effective Drug Enforcement Act of 2016
Purpose: To enhance collaborative efforts between regulators and industry to promote patient access to medications, while preventing drug diversion. Enforcement Methods: Partnerships for supply chain integrity, adjusting enforcement policies, promoting patient access.
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