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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
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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
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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.
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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.
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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.
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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.
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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.
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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
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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.
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Ensure safe and effective prescription drug distribution
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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.
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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.
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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.
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Medicare part D; prescription drug benefits for medicare patients. Benefits are voluntary and patients must enroll in it during a designated period each year.
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Law that classified anabolic steroids as schedule-III controlled substances
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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.
