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The Pure Food & Drug Act
Required that drugs not be mislabeled. Drugs were required to meet standard set by industry. However, manufacturer's could still false claim the therapeutic effects of the drug. Also prohibits interstate transportation -
The Food, Drug, and Cosmetic Act
Legally defined what a drug is and established policies to determine safety. 1.Items listed in the official united states pharmacopoeia, (USP), the national formulary (NF) or the homeopathic pharmacopoeia of the united states 2. anything intended for use in the prevention, treatment, cure, diagnosis, or mitigation of disease 3. anything that is intended to affect the structure or function of the body of man or other animal. Any manufacturer wanting to produce a new drug must fill out a NDA -
Durham-Humphrey Amendment
A amendment of the FDCA, distinguishing medications into two categories: Over the counter & Prescription (OTC & Rx). "Caution: Federal law prohibits dispensing without a prescription" this how prescription drugs became known as "legend drugs". Required pharmacists to obtain permission verbal or written to dispense a prescription drug. -
Kefauver-Harris Amendment
Required all medication to be both safe and effective in addition to the FDCA. Passed in response to severe birth defects seen in children out side of the US after pregnant women took thalidomide for morning sickness. -
Controlled Substances Act
Start of DEA (Drug Enforcement Act), categorizes drugs into five schedules depending on medical use and if they can become addictive. Schedule III-V are considered good drugs, they are used for medical reasons, and not likely to be addictive/abused. Schedule II drugs are in between good and bad, they are used because of medical reasons but however can be addictive. Schedule I drugs are considered bad drugs, not used for medical reasons, and are highly addictive. -
The Poison Prevention Packaging Act
Requires that household substances be packaged in child resistant packaging. Should be difficult for children under five to open but easy for adults to open. -
Occupational Safety & Health Act
Made to assure safe and healthy working conditions for working men and women. Authorizes enforcement of the standards. Assists and encourages the states to assure safe and healthy working conditions for workers. -
Drug Listing Act
Requires registered drug establishments the FDA with current list of drugs prepared and made at their facility. When first passed they also wanted to inspect drug establishments -
Orphan Drug List
Law passed in the US to allow development of orphan drugs for rare diseases that affect a small number of individuals.Such as ALS, Tourette syndrome, muscular dystrophy, etc. -
Prescription Drug Marketing Act
Ensure safe and effective prescription drug distribution -
The Omnibus Budget Reconciliation Act (OBRA)
Created to reduce the US budget but largely impacted the health care system. Making pharmacy technicians tell patients how to use medication, how often to use it and review patient information. -
Dietary Supplement Health and Education Act (DSHEA)
Requires all herbal products to be labeled as a dietary supplement and identify all ingredients. They are only required to meet quality and purity specifications not to prove safety or effectiveness. -
The Health Insurance Portability and Accountability Act (HIPAA)
Protect privacy of patients protected health information. Regulations include how to store information and when it is appropriate to access them. Designed to PROTECT the PUBLIC. -
Medicare Prescription Drug Improvement and Modernization Act of 2003
Medicare part D; prescription drug benefits for medicare patients. Benefits are voluntary and patients must enroll in it during a designated period each year. -
Anabolic Steroid Control Act
Law that classified anabolic steroids as schedule-III controlled substances -
Combat Methamphetamine Epidemic Act
Passed to aid in the restriction of sales of ephedrine, pseudoephedrine, phenylpropanolamine. These drugs and products were placed in the "scheduled listed chemical products" category. Sales of these drugs and products have restrictions and require record keeping. Purchase limit of 3.6 g a day to 9 g a month. Pharmacy must keep written or electronic records of sales. Product name, quantity sold, name and address of purchaser, day and time sold.
