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Federal Law

Federal law requires that all prescriptions expire ___ year from the date written. one
PRN indicates "_______" within the one year requirements. refills as needed
The Pure Food and Drug Act: 1906, required all foods and drugs to meet a standard of purity and strength.
The Harrison Narcotic Act, created in 1914, regulated: opium, marijuana, synthetic agents, derivatives
The Federal Food, Drug, and Cosmetic Act (FFDDCA) required that: 1938, manufacturers proved their drugs/cosmetics were safe and medical devices were effective.
The Federal Food, Drug and Cosmetic Act gave the FDA: limited authority to remove products that they found to be unsafe and ineffective.
The Durham-Humphrey Amendments to the FFDDCA: clarified distinction between Rx and OTC based on whether they were habit-forming, narcotic, hypnotic, or harmful.
The Durham-Humphrey Amendments to the FFDDCA required: a Rx to dispense refills, which created the legend "Caution: Federal law prohibits dispensing without a Rx"
The Poison Packing Prevention Act: 1970, required child proof packging
The Controlled Substances Act: 1970, classified drugs based on their potential for abuse (Sch. I-V), it also required that all controlled substances bear the label: "Federal law prohibits the transfer of this drug to any other person other than the patient for whom prescribed"
The Joint Commission's mission is to: improve the quality of care provided to the genera public.
The JCHAO is responsible for: accreditation of institutional settings
OSHA is responsible for: safety in the workplace.
American Association of Pharmacy Tech. : 1979, set forth 10 codes of ethics that details the responsibilities of the tech. while protecting their rights to due process.
Prescription Marketing Act of 1987: enacted to address certain Rx drug marketing practices that have contributed to the diversion of drugs into a secondary gray market
Omnibus Budget Reconciliation Act (OBRA 90) required: pharmacists to offer counseling to Medicaid patients
Anabolic Steroids Act of 1990: places any drug or hormonal substance related to testosterone under regulation of the Controlled Substances Act
FDA Modernization Act of 1997; changed labeling requirements to "Rx only"
Medicare Modernization Act (MMA): 2003, produced largest overhaul of Medicare and created Medicare Part D
Combat Methamphetamine Epidemic Act of 2005 (CMEA) regulated: ephedrine, pseudophedrine, and phenlypropanolamine
Patient Safety and Quality Improvement of 2005's goal is to: encourage reporting of events that adversely affect patients
Schedule I drugs: have the potential to be highly abused and are not accepted for medical use.
Schedule II drugs require: a Rx and are not refillable.
When dispensing partial fillings of Sch. II drugs, the pharmacist needs to: record the number dispensed and dispense the remainder within 72 hours.
Partials for patients in long term care is valid for ___ days. 60
In an emergency situation, a Sch. II Rx can be called via telephone only if: - immediate administration is required - no alternatives are available - physician cannot reasonably provide a written Rx - pharmacy must receive hard copy of Rx within 7 days
Use DEA Form ___ to report theft of Sch. II drug. 106
All ____ products are now a Sch. II drug. Hydrocodone
Schedule III drugs can be refilled up to: five times within six months
Schedule IV drugs have: the same dispensing rules as Sch. III
Benzodiapines are: Schedule IV drugs
Schedule V drugs can be sold OTC only if: - the customer is over 21 - the substance is sold by the pharmacist - not more than 240 oz of opoid containing substances or 120 ml of non-containing substances may be dispensed within 48 hours - must have a record book
All records of controlled substances must be kept for at least ____ years for inspection. 2
Sch. II records must be maintained _____ from Sch. III-V records. seperately
DEA form ___ is used to order Sch. II substances, return to supplier, and send to the reverse distributor. 222
DEA form ___ is used to dispose of controlled substances. 41
A red "C" must be used and stamped _____ to identify Sch. III-V Rx. an inch high
If there is a conflict between federal and state requirements for filing Rx: you should use the stricter of the two.
The first letter of a DEA number identifies _______. the type of prescriber.
The second letter a DEA number identifies ______. the first letter of the prescriber's last name.
An inventory is defined as: a complete and accurate list of controlled substances.
When recording the number of Sch. II drugs in possession, an ____ count or measure is required. exact
When recording the number of Sch. III-V drugs: an estimated count is required, unless the contents hold more than 1,000
The pharmacy is required to do inventory check every __________. two years
Sch. II drugs must be in a _________. locked cabinet or distributed throughout general stock.
Sch III-V drugs can be ordered by calling the __________. wholesaler
Investigational drugs go through _________ before being released to the general public. 4 phases of testing
Phase I: drug is introduced for public use and patients volunteer to participate.
Phase II: establishes effectiveness and safety and patients are closely monitored.
Phase III: specifies effective/indications and adverse effects are studied.
Phase IV: Post marketing trials, no controlled involved, remaining drugs are returned.
Created by: Michelle Lee



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