Pharm. Law

1906: The Pure Food & Drug Act
this act required all food and drugs to meet a standard purity and strength
1914: The Harrison Narcotic Act
this act regulated drugs that produced or sustained physical or psychological dependence ex: marijuana, synthetic agents synthetic, derivatives
1938: The Federal Food, Drug, and Cosmetic Act
-manufacturers of drugs and cosmetics must prove that their products are safe
-medical devices must be proved effective
This gave the FDA limited authority to remove products from the marketplace if they are found to be ineffective or unsafe.`
1951: The Durham-Humphrey Amendments to the FFDCA
-Further clarified the distinction between prescription and over the counter drugs based on whether or not the drugs were habit forming, narcotic, hypnotic, or potentially harmful
-Required physician’s consent in order to dispense refills, giving rise to the legend, “Caution: Federal law prohibits dispensing without prescription.” Warning must be affixed on all legend containers
1962: The Kewfauver-Harris Amendments to the FFDCA
required drug manufacturers to prove the safety and efficacy of their products before the approval was given by the FDA for marketing
1970: Poison Prevention Packaging Act
requires child proof packaging
1970: Controlled Substances Act (CSA)
classified drugs based on the potential for abuse, Schedule I, II, III,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.”
The Joint Commission
The mission of the Joint Commission is to improve the quality of care provided to the general public. The Joint Commission is responsible for accreditation of institutional settings.
1987: Prescription Drug Marketing Act of 1987 (PDMA)
PDMA 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 the secondary gray market.
EX: sale or distribution of free samples
sale of deeply discounted drugs intended for the use in hospitals and health care entities
1990: Omnibus Budget Reconciliation Act (OBRA-90)
This act required pharmacists to offer counseling to Medicaid patients regarding medications
The Anabolic Steroids Control Act of 1990
this act places “any drug or hormonal substance chemically and pharmacologically related to testosterone” under the regulatory provisions of the Controlled Substance Act.
1996: Health Insurance Portability and Accountability Act of 1996 (HIPPA)
First comprehensive federal regulation designed to safeguard the privacy of the protected health info. (PHI)
1997: FDA Modernization Act
This act changed the legend requirements to “Rx Only”
2003: Medicare Prescription Drug, Improvement, and Modernization Act (Medicare Modernization Act)
produced the largest overhaul of Medicare in the public health program’s history. The MMA was signed, creating Medicare part D. These programs subsidize the costs of prescription drugs of Medicare Beneficiaries and went into effect on Jan. 1, 2006
2005: The Combat Methamphetamine Epidemic Act of 2005 (CMEA)
was to regulate, retail over-the-counter sales of: ephedrine, pseudoephedrine, and phenylpropanolamine- all used to illegally make meth
2005: The Patient Safety and Quality Improvement Act of 2005
the goal of this act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.
Controlled Substances Act (CSA) 1970
enacted to improve the administration and regulation of all parties involved in the manufacturing, distribution, and dispensing of controlled substances.
Food Drug and Cosmetic Act of 1938 (FDCA 1938)
-clearly defined adulteration and misbranding of drugs and food products
-The U.S. Food and Drug Administration (FDA) was created under the FDCA 1938
-defined manufacturer drug labeling and OTC packaging labeling
-required all new drug applications be filed with the FDA
1994: Diet Supplement Health and Education Act
herbal products are dietary supplements rather than drugs. The manufacturers of the supplements are allowed to make claims with regard to general health promotion but not disease claims.
Occupational Safety & Health Act of 1970
Ensures a safe and healthful workplace for employees
Drug Listing Act of 1972
Each drug is assigned a specific 11 digit number to identify it. This # is called a national drug code (NDC)
-first 5 digits rep. manufacturer
-next 4 rep. the drug product
– the final 2 rep the package size
Medicaid Tamper-Resistant Prescription Act 2008
-act enacted to prevent copying prescription pads
-prescription pad must be designed and made to prevent erasure and modification and counterfeiting, etc. of prescriptions
Hatch-Waxman Act of 1984
Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses
Resource Conservation and Recovery Act (RCRA) 1970
pharmacies arrange for the disposal of their hazardous wastes through an outside vendor
Food and Drug Administration Safe Medical Devices Act 1990
all medical devices are to be tracked and records maintained for durable medical equipment
Orphan Drug Act of 1983
orphan drugs are medications for treatment of diseases or conditions of which their are fewer than 200,000 cases in the world
Prescription Drug Marketing Act of 1987
-forbids the sale or distribution of samples to anyone other than those licensed to prescribe them
-requires “Caution use by or on an order of a licensed veterinarian”
Federal Privacy Act of 1974
-regulates what personal info the federal government can collect on private individuals and how that info. can be used
-people have the right to see the info. the govt. has about them
Omnibus Budget Reconciliation Act 1987 (OBRA 87)
requires state and federal govt. to inspect nursing homes