ZFederal Law
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| A few exemptions from DEA registration | show 🗑
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| show | DEA 224
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| show | True
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| show | 14 (name address, and DEA # of old business AND new business)
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| show | 1+5+2=8; 3+7+1 =11x2=22 +8 =30; the zero at end is verified by the zero at end of DEA #
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| show | True
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| show | Inventory, drugs received( invoices for C3-C5 and DEA222 for C2), and drugs dispersed
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| Which form is used if theft or loss occurs? | show 🗑
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| show | DEA 41
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| Requires all OTC and prescription drugs be subject to special packing requirements | show 🗑
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| Established 2 classes of drug, prescription and OTC | show 🗑
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| Required drugs be proven safe and effective | show 🗑
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| show | harrison narcotic act
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| show | PHI
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| Established a formal definition of dietary supplements using several criteria | show 🗑
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| Official compendia of active ingredients | show 🗑
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| show | FDAMA
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| show | Prospective DUR
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| Act that provides storage, handling, and recordkeeping for drug samples | show 🗑
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| Act regarding safety and efficacy of medical devices according to their function | show 🗑
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| show | of medicare/ Medicaid
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| show | Orphandrug
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| show | HIPPA
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| Authorized batch certification on insulin and penicillin | show 🗑
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| Dept of health and human services is an example of what kind of agency? | show 🗑
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| Fair Trade Commission is what kind of agency? | show 🗑
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| show | Fed admin agency; DEA
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| State Board of Pharmacy puts in details for legislatures framework | show 🗑
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| 4 types of law | show 🗑
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| show | Civil
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| Failing to do something that a reasonable person would do | show 🗑
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| show | Commission
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| a violation of the legal obligation to an individual; ex: misfilling a prescription | show 🗑
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| show | Duty owed
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| Proof that pharmacists misconduct caused the alleged damage | show 🗑
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| show | Damage
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| 4 elements of negligence (all 4 needed to be legally liable) | show 🗑
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| show | Habit forming OR not safe w/o supervision OR is limited by application to be used under supervision
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| show | Current good manufacturing practices
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| Drugs recognized among experts to be safe and effective | show 🗑
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| Obtaining FDA Pre-marketing drug approval; new use for previously approved drugs | show 🗑
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| once the patent on an approved parent drug product expires, the FDA allows manufacturers of generic products to submit a what? ANDA | show 🗑
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| show | Abbreviated New Drug Application; no safety or efficacy data required; have to prove it’s the same bioequivalence
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| show | SNDA (Supplemental New Drug Application)
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| show | OTC’s broken down into categories instead of making each go thru FDA process; list of safe products that can be used in a new product
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| show | NDC (National Drug Code); required on all OTC AND prescription labels
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| show | manufacturer or distributor
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| show | “product”
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| Third section of NDC | show 🗑
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| Concerned with physical condition of drug or device | show 🗑
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| show | misbranding
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| False or misleading label, inadequate directions for use, doesn’t warn of possible habit forming | show 🗑
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| show | Adulteration
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| show | Misbranding; every batch tested for strength and quality
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| Label vs labeling | show 🗑
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| show | MedGuides and Consumer Medication Information (CMI)
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| show | MedGuides of Patient Info Program; Manufacturer provides to dispenser, dispenser provides to patient
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| Mandated that written information is provided to the patient for every drug every time a new prescription is dispensed | show 🗑
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| show | Class I, irreversible damage/ death; class II reversible damage; class III often mislabeling; FDA does tell public which class
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| show | True
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| Product recall withdrawal process | show 🗑
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| set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packing, or holding of a drug product | show 🗑
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| The intent of the GMP is to do what? | show 🗑
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| Manufacturers are inspected by FDA how often? | show 🗑
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| show | Orange book
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| Two-letter coding system for the therapeutic equivalence; first letter is either an A or a B | show 🗑
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| show | Gives info about dosing- ex: oil or aerosol
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| show | Voluntary Reporting Programs
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| Pharmacists must provide: “Call your doctor for medical advice about side effects; You may report side effects to the FDA at 1-800-FDA-1088” | show 🗑
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| Clinical trials Phase I | show 🗑
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| Clinical trials phase II | show 🗑
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| Clinical trials phase III | show 🗑
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| Clinical trials phase IV | show 🗑
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| show | US Pharmacopia
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| show | NF (National Formulary)
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| USP and NF joined into 1 compendium for drug standards | show 🗑
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| HPUS is what? | show 🗑
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| Prohibited the adulteration/ misbranding of drugs; not required to list ingredients; no authority to ban drugs | show 🗑
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| show | Harrison Narcotic act of 1914
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| Authorized batch certification AND required new drugs to be proven safe before marketed | show 🗑
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| show | durham- Humphrey; must contain “ federal law prohibits dispensing without prescription
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| Adequate info vs adequate directions | show 🗑
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| show | Kefauver- Harris
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| show | Kefauver- Harris; legend (prescription drugs)=FDA ; OTC= Federal trade commission
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| Special packaging and child resistant packaging | show 🗑
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| Medical Devices Act: 3 classes according to function | show 🗑
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| Tax/ licensing incentives for manufacturers to develop and market drugs for rare diseases | show 🗑
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| Extended patent to 5 years after FDA approval; streamlined generic drug approval process | show 🗑
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| Requirements for samples | show 🗑
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| show | OBRA 90 (Omnibus Budget Reconciliation Act)
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| show | Rebates, innovation, drug utilization review
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| show | Screening prescriptions prior to dispense, patient counseling, and pharmacist documentation of relevant info (allergies etc)
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| Annual Fees on manufacturers; allowed more FDA employees and faster drug approval | show 🗑
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| show | (Dietary Supplement Health and Education); product other than tobacco; vitamin, mineral, herb, amino acid orcombo of these
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| show | DSHEA
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| Fast track approval for life threatening disease; data base for clinical trials; panel review; “off-label”uses | show 🗑
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| Incentives for creating PEDIATRIC clinical studies | show 🗑
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| Designed to stimulate additional research into pediatric data for pharmaceuticals | show 🗑
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| show | Pediatrics Research Equity Act
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| Gives FDA more authority to remove unsafe dietary supplements (DS) and OTC products | show 🗑
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| Examples of individually identifiable health info | show 🗑
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| show | covered entities
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| show | health plans, clearing houses(billing etc), electronic transmission by health care provider
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| show | Office of Civil Rights; civil penalties 25k,criminal penalties 50k, intent to sell 250k and prison
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| show | Controlled Substance Act; enforces by DEA (agency of US dept of Justice)
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| Goal of this act is to trace controlled substances and prevent diversion | show 🗑
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| Controlled drugs/ scheduled drugs: | show 🗑
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| Narcotic controlled substance is defined as? | show 🗑
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| Who has the authority to place a schedule on a drug? | show 🗑
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| Used in research; high potential for abuse; no current accepted medical use | show 🗑
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| Manufacturers and distributors register with the DEA how often? | show 🗑
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| show | Determined by AG; 1-3 years. nevada is 2 years
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| Dispense: | show 🗑
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| Inventory of CII is required how often? | show 🗑
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| show | initial and then every 2 years; doesn't need to be submitted to DEA but needs to be kept in records
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| show | opened bottle holds less than 1000 units; must be counted if bottle holds more than 1,000 units
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| show | DEA Form 41; DEA will instruct registrant how to dispose; transfer, deliver to DEA, destroy in presence of DEA, other DEA authorized means
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| show | pharmacist, licensed physician, midlevel practitioner, nurse or state/ local law enforcement
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| New pharmacy initially registers to order CS with which form? | show 🗑
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| show | CI CII drugs, triplicate, serial #, states which schedules registrant is allowed to handle
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| show | CI and CII- DEA 222; CIII-V- invoice or packing slip with drug name, dosage and strength, number of units/containers; supplier info
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| Form 222 copies | show 🗑
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| show | power of attorney designated by person who signed DEA registration; can sign 222 on behalf of the signer (requires 2 witnesses)
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| Pharmacist needs to mark if something not received or can face huge fine | show 🗑
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| show | misspelled drug name, no date, package size (if only 1 package size available), strength (if only 1 strength). Supplier cannot fill in "last line completed"
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| Electronic ordering of CI-CV is allowed if? | show 🗑
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| CII must be hand written; III-V can be verbal or written | show 🗑
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| Oral Emergency CII prescription | show 🗑
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| Fax requirements | show 🗑
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| show | compounded for direct admin, LTCF, hospice
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| State Board determines if electronic prescribing is allowed | show 🗑
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| show | date of dispense, pharmacy name/ address (phone not req), script #,patient/physician name, directions for use, cautionary statements
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| Partial filling: must be able to supply full amount within 72 hours or do what? | show 🗑
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| partial filling of CII for LTCF patient; script is good for how mong? | show 🗑
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| show | no expiration under Federal Law p.61
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| show | 6 months, no more than 5 refills
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| show | 12 months, can prescribe as needed for refills
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| show | not more than 90 day supply; if 3 separate scripts are written for 30 days each, they must have instructions on fill dates
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| show | pharmacy- locked cabinet or mixed in with other meds to deter theft. Dr office must have them in a locket cabinet
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| show | CIII-CV can be transferred 1 time
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| Can a CS be mailed? Which classes? | show 🗑
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| Can CS's be delivered or shipped out of country? | show 🗑
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| show | 3.6 g/ day or 9 g/ month; less if mail order
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