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Pharmacy Law
Brief History of US Drug Law
| Legal Incident | What it did |
|---|---|
| The Import Drugs Act | First federal drug act attempting to ensure the quality of drugs. Provided for lab inspection at ports of entry and for detention, destruction or re-exportation when USP standards not met. Failed due to lack of enforcement |
| Dr. Wiley | Chief chemist for the USDA, his poion squad scientifically tested foods laced c preservatives to determine their toxic effects. Preservatives such as borax, dyes, formaldehyde more common as nation grew and industrialized and packed/shipped more food. |
| Biologics Control Act | Required licensing and regulation of the interstate sale of serums and vaccines. Resulted from tetanus-contaminated diptheria antitoxin made by the STL Health Dept. |
| Pure Food and Drug Act | Signed by Teddy Roosevelt. Prohibited sale of adulterated (not as labeled; differs in strength, quality or purity; contains filthy, decomposed, putrid substances) or misbranded (false label statements about ID of ingredients) food, drinks, and drugs |
| US vs Johnson | Dr. Johnson's Mild Combination Treatment for Cancer. Supreme Court ruled that only false and misleading claims as to the identity of the drug were prohibited, but not false therapeutic claims. |
| Sherley Amendments | Prohibited false & fraudulent label claims of therapeuic effectiveness. Gov't had to prove the promoter of worthless drugs deliberately lied to defraud the public, virtually impossible. Manufacturers simply transferred claims from labels to advertising |
| Harrison Narcotic Act | Required licensing of those importing, manufacturing, compounding, selling, and dispensing opium and coca leaves and all derivative preparations. Required prescriptions for dispensing narcotics. |
| Elixir of Sulfanilamide | Miracle drugs, but tasted bad and hard to swallow. Massingill made a yummy raspberry flavored liquid using diethylene glycol as the solvent, killed 107 people |
| ENSOL | Used in cancer therapy. 125K bottles were imported and given free by doctors to cancer patients. 6 deaths from contamination with tetanus. No regulation since imported plus not sold. |
| Insulin Certification Amendments | U of Toronto patented insulin and the manufacturing process. Issued licenses to ensure a standardized product during commercial manufacturing. When the patent expired, the FDCA was amended to ensure a continuous stream of standardized insulin. |
| Durham-Humphrey Amendments | Drugs that can't be used safely w/o supervision must be dispensed only by Rx. Created 2 categories of drugs: Rx and nonRX. Prohibited refills w/o prescriber consent. Specified what minimal info must be on the Rx label. |
| Thalidomide | New OTC drug in Europe and Canada as a sleeping agent for pregnant women. Thousands of babies born with phocomelia. FDA cheif medical officer, Francis Kelsey, refused to relase drug into US marketplace. |
| Kefauver-Harris Act (Drug Efficacy Amendements) | Manufactuers must provide package inserts, register with FDA, have FDA approve ads, informed consent before human trials. Also prove safety AND efficacy of their drugs. Required retrospective review of all drugs approved over last 24 years. |
| Drug Efficacy Study Implementation (DESI) | Evaluated all Rx drugs (previously approved on safety alone) for effectiveness, result of the Kefauver-Harris Act. 4 categories: effective, probably eff, probably ineffective, ineff. Removed many drugs from market, required many to be further studied |
| Controlled Substances Act | Created 5 federal schedules of controlled substances based on their relative potential for abuse and a "closed record keeping system" |
| Poison Prevention Packaging Act | Administered and enforced by the Consumer Products Safety Commission. Enacted to prevent accidental poisoning of children by requiring child-resistant closures for all RX and some OTC products. Extended to include almost all harmful household products. |
| OTC Drug Review | Further implemented the Drug Efficacy Amendments by analyzing over 300K OTC products, classifying them into 3 categories. |
| Medical Device Amendments | Assures safety and effectiveness of medical devices, including certain diagnostic and lab products by enhancing FDA authority over such items |
| Federal Anti-Tampering Act | Response to deliberate contamination of Tylenol. Packages "must have and indicator or barrier to entry which when breached or missing, will provide visible evidence to consumers that tampering has occured." For certain OTC products, cosmetics, med devices |
| Orphan Drug Act | Provides incentives to manufacturers to research, develop and market drug products intended for the treatment of rare diseaes or medical conditions in the US. Commercial markets sufficient to recover costs do not exist |
| Price Competition and Patent Restoration Act | Title I: FDA can accept Abbreviated New Drug Apps for generics. Must be bioequivalent to pioneer drugs. Safety and efficacy data not needed if on file for pioneer. Title II: Patent life may be extended up to 5 yrs to cover time lost in FDA review period |
| Prescription Drug Marketing Act (PDMA) | Designed to control the distribution of Rx drugs through legitimate channels. States must license wholesale distributors, hospitals may not resell Rx drugs. Bans sale, trade, and purchase of Rx samples and requires all requests for samples be in writing |
| Ominbus Budget Reconciliation Act (OBRA 90) | Fed gov't can take advantage of discounts afforded to large institutional buyers of drugs through "best price" rebate program. RPhs must report NDC #s for all drugs dispensed to Medicaid recipients and must counsel Medicaid patients on all new Rxs |
| Prescription Drug User Fee Act (PDUFA) | Intended to generate funds to accelerate drug approval. FDA can charge drug manufacturers fees to help defray cost of review process, reducing approval time from >30 mo to ~13 mo |
| Health Insurance Portability and Accountability Act | Individuals can't be denied health insurance, exclusionary periods limited to 1 yr and can't be imposed on previously insured c no break in coverage. Must provide plans for ind. & small companies, can't cancel previously available plans. Also Privacy Rule |
| National Formulary | Lists inactive ingredients used in preparing drugs, now published with USP |
| US Pharmacopeia | 1.Selects drug substances c most fully established utility 2. Make from these substances compounds that would use their therapeutic powers to best advantage 3.Distinguish these substances by convenient and definite names to minimuze confusion |
| UPS/NF | legally recognized standards for drugs and excipients; specifications for packaging, labeling, and storage; tests and assays for strength, quality, purity and ID; standards for med devices and dietary supplements |
| The Food, Drug, and Cosmetic Act | Required drugs be tested for safety, labeled c essential info & adequate directions, drugs too dangerous for self-use be labeled for Rx only, med devices to be safe & effective, and cosmetics to be safe. Mandated New Drug Apps & unannounced inspections |
Created by:
glenna
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