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This act requires all food and drugs to meet a standard of strength and purity
The pure food and drug act
to enforce the controlled substance laws and regulations of the US
Required that: Manufacturers of drugs and cosmetics must prove that their products are safe
The Food, Drug, and Cosmetic Act (FDCA)
Further clarified the distinction between prescription and over-the-counter (OTC) drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful.
The Durham-Humphrey Amendment
This required drug manufactures to prove the safety and efficacy of their products
before approval was given by the FDA for marketing.
The Kefauver-Harris Amendment
This act requires child-proof packaging.
Poison Prevention Packaging Act
Classified drugs based on their potential for abuse, Schedule I, Il, Ill, IV, & V. Federal law
requires that all controlled substances dispensed bear the following: "Federal law prohibits the transfer of this drug to any person other than patient for whom prescribed.
Controlled Substances Act (CSA)
Act was created to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance.
Occupational Safety and Health Act
Assigned each drug a specific 11 digit known as National Drug Code
Drug Listing Act
Passed to expedite development of drugs for rare diseases such as Huntington's disease, myoclonus, ALS (Lou Gehrig's Disease), Tourette syndrome, and muscular dystrophy.
Orphan Drug Act
is a part of the FDC Act, which was enacted to address certain prescription drug-marketing practices that have contributed to the diversion of drugs into a secondary gray market.
Prescription Drug Marketing Act of 1987 (PDMA)
This act required pharmacists to offer counseling to Medicaid patients regarding medications.
Omnibus Budget Reconciliation Act (OBRA-90)
This act places "any drug or hormonal substance chemically and pharmacologically related to testosterone" under regulatory provisions of the Controlled Substance Act.
The Anabolic Steroids Control Act of 1990
The privacy rule took effect on April 14, 2003, and was the first comprehensive federal regulation designed to safeguard the privacy of protected health information (PHI).
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
theft of controlled substances
DEA form 106
This act produced the largest overhaul of Medicare in the public health program's history. This was signed in December 8, 2003 creating Medicare Part D. These programs subsidize the costs of prescription drugs for Medicare beneficiaries and went into effect on January 1, 2006.
2003: Medicare Prescription Drug, Improvement, and Modernization Act (Also called the Medicare Modernization Act or MMA)
(CMEA) was to regulate, retail over-the-counter sales of:
o Ephedrine (used illegally to make methamphetamine)
o Pseudoephedrine (used illegally to make methamphetamine)
The Combat Methamphetamine Epidemic Act of 2005.
registers and regulates pharmacy facilities, pharmacist and pharmacy technicians
State Board of Pharmacy
voluntary surrender of controlled substances
DEA form 104
Outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
2013 Drug Supply Chain Security Act (DSCSA) aka Track and Trace
The mission of _______ is to improve the quality of care provided to the general public. Also is responsible for accreditation of institutional settings.
The Joint Commission
ordering or transferring of controlled substances
DEA form 222
founded in 1979, set forth a code of ethics that details the responsibilities of the pharmacy technician while protecting their right to due process.
The American Association of Pharmacy Technicians (AAPT)
is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Food and Drug Administration
used to destroy controlled substances
DEA form 41