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An overview of various regulations and requirements related to drug labeling, manufacturing, and dispensing in the united states. It covers topics such as drug misbranding, the kefauver-harris amendment, the prescription drug marketing act, the biologics price competition and innovation act, the comprehensive addiction and recovery act, and the responsibilities of pharmacy interns in new jersey. The document also discusses requirements for compounded drugs, beyond-use dating, handling of hazardous drugs, prescription refusal policies, dea registration, e-prescribing, and labeling requirements for controlled substances. Additionally, it covers information on generic drug names, air quality standards, and therapeutic interchange. This comprehensive document could be useful for students studying pharmacy, pharmaceutical sciences, or healthcare regulations.
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Neither _____ nor _____ are required by an ANDA. ✔✔-pre-clinical animal studies
-clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulatedby the _____. ✔✔-FDA
-FTC (Federal Trade Commission)
Any false or misleading statements in a drug advertisement could be considered _____.misbranding ✔✔-
Pure Food and Drug Act (1906) descriptionrequired that the ingredients used in drugs met the standards of strength, quality, and purity in ✔✔-mandated accurate product labeling and USP -required that the food or drug label could not be false or misleading, and the presence andamount of eleven dangerous ingredients, including alcohol, heroin, and cocaine had to be listed
-required that no adulterated or misbranded drugs could be sent through interstate commerce
Food Drug and Cosmetic Act (1938) descriptiondue to diethylene glycol poisoning* ✔✔-resulted from the *sulfanilamide deaths
-required that the manufacturer (not the FDA) prove the safety of a drug before it could bemarketed
-defined foods, drugs, dietary supplements, cosmetics, and devices
drug adulteration description ✔✔-filthy, putrid, or decomposed
-any false or misleading information, such as imitating the properties of another drug orpromising false cures
-lack of special precautions needed to prevent decomposition that must be specified on thepackage (e.g. "protect from light" or "keep in original container)
-illegible information -lack of the proprietary or established generic name -the ingredients differ from the standard strength, quality, or purity as determined by USP -lack of the manufacturer, packer, and distributor location -improper packaging (e.g. no package insert or medication guide) or improper or incompletelabeling of additives
-deficiency in packaging requirements determined by the Poison Prevention Packaging Act
Durham-Humphrey Amendment (1951) descriptionbetween OTC and prescription drugs ✔✔-first time clear distinction was made
-drugs that were habit forming, those considered unsafe except under expert supervision due totoxicity, and those limited to Rx only by the manufacturer's NDA were made available only by prescription -authorized refills and telephone prescriptions -required adequate directions for use
_____ is another term used to describe prescription drugs. ✔✔-legend drugs
Durham-Humphrey required that OTC drugs contain _____ in the Drug Facts Label.adequate directions for use ✔✔-
*e.g. safety in pregnancy and breast feeding, calcium, sodium, magnesium, potassium content,etc.
The Controlled Substances Act of 1970 was designed to establish a _____ of the manufacturing,distribution, and dispensing of drugs with the purpose of _____. ✔✔-closed system
-reducing drug diversion The Poison Prevention and Packaging Act of 1970 requires a number of household substancesand drugs to be packaged in _____. ✔✔-child-resistant (C-R) packaging
The Drug Listing Act of 1970 required that all drug establishments register with the FDA andall drugs have a unique _____. ✔✔-NDC number
The NDC number contains _____ digits with _____ segments. ✔✔-10-
three segments of an NDCcorrespond to the manufacturer ✔✔1. labeler code: first 4 or 5 digits assigned by the FDA that
The Federal Anti-Tampering Act of 1982 required that tamper-resistant features be present onall _____. ✔✔-OTC medications (passed because of Tylenol tampering)
*certain products are exempt - skin products, insulin, lozenges, tooth cleaning powder
criteria for orphan drugs under the Orphan Drug Act of 1983 (2)disease that affects less than 200,000 people in the US ✔✔1. the drug will treat a
OR
requirements for a 505(b)(2) application (paper NDA)submit evidence of previously published reports of investigations of safety and effectiveness ✔✔-the generic drug company must
Prescription Drug Marketing Act (1987) descriptioncountries and bring them to the US except under 1 of 2 conditions: ✔✔-made it illegal to buy drugs in other
-also restricted hospital selling of drugs and prohibited selling of drug samples
Omnibus Budget Reconciliation Act (OBRA) (1990) descriptionperform a prospective drug utilization review and counseling for all Medicaid beneficiaries ✔✔-required the pharmacist to
-also required that states perform a retrospective drug utilization review *most states have expanded the counseling requirements to all patients The Dietary Supplement Health and Education Act of 1984 (DSHEA) established that dietarysupplements do not need _____ to be marketed, but the supplement was still prohibited from being _____. ✔✔-FDA approval
-adulterated or misbranded *FDA only reviews if the the product contains a new dietary ingredient, otherwise managed bythe FTC
*not expanded to mid-level providers yet
REMS programs were established by the _____. ✔✔-FDA Amendments Act of 2007
Biologics Price Competition and Innovation Act (2009) descriptionpathway* for biological products that are demonstrated to be biosimilar to or *interchangeable ✔✔-created an abbreviated with an FDA-approved biological product
requirements for a biosimilar ✔✔1. same mechanism of action
*cannot be considered bioequivalent
Drug Quality and Security Act (2013) descriptioncompounders and outsourcing facilities (i.e. 503B facilities)* ✔✔-makes a *distinction between traditional
-drugs compounded in outsourcing facilities are exempt from the FDA new drug approvalprocess and certain labeling requirements, but need to comply with CGMP requirements, report adverse events, and provide the FDA with certain information about the products theycompound
-the Drug Supply Chain Security requires that all transactions of prescription drugs throughthe pharmaceutical supply chain be documented
new categories established by the Pregnancy and Nursing Labeling Final Rule of 2014 (3) ✔✔1. pregnancy: labor and delivery guidelines fall under this category, which includes information for pregnancy exposure registries
Of the 30 CE credits required in NJ, _____ must be related to opioid drugs and _____ must berelated to pharmacy law. ✔✔-1 credit
-3 credits
Of the 30 CE credits, _____ must be didactic in nature. ✔✔-10 credits
*in-person instruction - may include telephonic or electronic instruction that is interactive (i.e.questions can be asked), but not videotaped instruction
_____ may be carried over into a succeeding biennial period only if such credits were earnedduring the last six months of the preceding biennial period and were not previously reported. ✔✔-10 CE credits
tasks that can be legally performed by pharmacy interns in NJsupervision of a pharmacist, including counseling and dispensing of schedule V OTCs ✔✔-pharmacist tasks under the
-retrieve prescription and patient files
-enter data -collect demographic or patient information -transcribe prescriptions -label preparations -prepare prescriptions -accept refill authorizations -administer certain vaccines
Pharmacy interns can provide _____ in NJ. ✔✔-counseling
primary certification exams for pharmacy technicians (2)Certification Examination* - developed by PTCB ✔✔1. *Pharmacy Technician
If the pharmacy is transferred to another owner, an _____ must be taken on the day the drugs aremoved, either before the day's shift has started, or at the end of the day. ✔✔-inventory of controlled substances According to the Drug Supply Chain Security Act of 2013, pharmacies must maintain _____,_____, and _____ for each drug received for _____ from the date of the transaction. ✔✔- transaction information -transaction history-a transaction statement
-6 years
pharmacist breaks requirements in NJadditional restroom breaks ✔✔-break is limited to 30 minutes for a meal and
-the pharmacist must remain onsite during the break -a sign must be posted that the pharmacist is on break but available for emergencies andcounseling
-support personnel can continue to work
controlled substance storage requirements (2) ✔✔1. in a locked cabinet
OR
Class I Recall definitionadverse health consequences or death* (e.g. morphine tablet manufactured at 10x the dose) ✔✔-reasonable probability that the use or exposure will cause *serious
Class II Recall definitionconsequences* or where the probability of harm is remote (e.g. possibility of particles in vials) ✔✔-use or exposure can cause *temporary or reversible adverse health
Class III Recall definitionconsequences* (e.g. coloring on tablets may have been applied inconsistently) ✔✔-use or exposure is *not likely to cause adverse health
