Law Exam 1 S
What act generally prevents reimportation of Rx drugs?
PDMA
Biologics are licensed under what act?
PHSA
What act made is so that device manufacturers have to follow GMPs?
Medical Device Amendments
What is a cosmetic?
articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering appearances
What does the definition of a device exclude?
articles that achieve their purpose through chemical action and metabolism
How does congress oversee administrative agencies?
appointment confirmations and appropriations to agencies
The Delaney Clause of the Food Additives Amendment (1958) prohibits what?
approval of food additives that may cause cancer
What is the role of the president in the legislative process?
approve or veto bill
What is the ISO goal for compounding sterile products?
class 5
How is bioequivalence established?
clinical trials done by manufacturer or if FDA can conclude it from other studies/facts submitted by company
What is injunction?
command to cease activities
What products cannot be compounded?
commercially available products, unless there is a shortage
How do courts make laws?
common law
Why does the FDA allow manufacturers to apply the adequate provision requirement to DTC advertising?
compliance with 502(n) is impractical
What did the Dietary Supplement Health and Education Act (1994) do?
created new special category of drugs called dietary supplements (DS)
What are the qualification, licensure requirements, supervision, and ratio requirements for ancillary personnel in a pharmacy?
depends on state
Who is authorized to dispense medications?
depends on state
Who has the authority to dispense?
depends on state law
What are the procedures when one receives an adulterated product?
destroy or quarantine and send back to manufacturer
What are the objectives in a criminal case?
deter, punish, rehabilitate
Who defines scope of authority?
determined by the state for prescribers who are not MDs or DOs
What do DS manufacturers responsible for?
determining if their product is safe and only making truthful / non-misleading claims substantiated by adequate evidence
In what order does personnel garbing take place in sterile compounding facilities?
dirtiest to cleanest article of clothing
What is the objective in an administrative hearing?
disciplinary determination that may include warning, fines, licensure revocation/suspension, or probation
What must DS labels contain?
disclaimer
Internet dispensing pharmacies are accredited by what body?
NABP
What kinds of drugs are required to be distributed with PPIs?
estrogens, oral contraceptives, DES
What reasons would a lower court have for deviating from precedent set out by stare decisis?
factual distinctions and changing times/circumstances
What is the Orange Book?
evaluates pharmaceutically equivalent products on basis of bioequivalence, and provides 2-letter rating system
What act is considered adulteration and misbranding?
failure to manufacture product in a tamper-resistant container when required by law
How often must PDUFA be reauthorized?
every 5 years
Who do federal laws apply to?
everybody
Courts generally regard labeling as what related to standard of care?
evidence toward, but not prima facie establishing standard of care
What is a 503A pharmacy?
exempt from misbranding, cGMP and new drug requirements if certain standards are met (prescription is for individual patient, limited quantity, and etc.)
What do adulteration provisions focus on?
facility and product
Does patient preference to not have safety caps have to be in writing?
no, but it should be
Can the FTC require that companies submit advertising to it for premarket approval?
no, must act after the fact
Are there any specific laws and regulations for direct-to-consumer advertising?
no, so 502(n) applies, even though it was originally intended to regulate advertising to healthcare professionals
What are FDA guidance documents?
non-legally binding/enforceable documents that explain compliance and should be followed
Without the prescriber's permission, either express or tacit, substitution is _____ _____ in most states, even if the consumer wishes a substitute.
not allowed
By what process are regulations enacted?
notice and comment rulemaking
What is stare decisis?
opinions are binding on lower courts in the same jurisdiction and serve as precedent
What is an example of a public good?
orphan drugs and vaccines
The 1990 OIG report found that pharmacy boards did not focus on what?
outcomes
What are three things the BOP should regulate for?
outcomes, structure, and funciton
What is a 503B facility?
outsourcing facility that has one geographic location engaged in compounding of sterile drugs
What is the difference between the federal register and the code of federal regulations?
fed. reg. is a daily publication of proposed/final regulations and notices, while CFR is an annually published compilation of final regulations divided and indexed by subject matter
Who indirectly establishes pharmacy standards of practice?
federal government
A state court is likely in the selection of courts unless....?
federal issue is involved or parties are from different states
What is the jurisdiction of the federal district courts?
federal law, constitutional issue, diversity citizenship, or if a state or the US is a party
Where do you find federal regulations?
federal register (fed. reg.) and code of federal regulations (CFR)
The lower the ISO number, the _____ larger-sized pariculate matter per cubic meter is allowed.
fewer
Why is state legislative history generally harder to determine than federal legislative history?
fewer written records of committee hearings / reports
What is USP <797>?
first set of enforceable sterile compounding standards issued by USP
What is direct regulation?
government makes decisions for people rather than helping them make it for themselves
In what case would a criminal case be applicable?
government v private party
Drugs approved before June 30, 2015 will be ______ _______ ______ the new labeling standards.
gradually phased into
Court decisions require that ______ ______ be used as a "safe harbor" in industry-supported education programs.
guidance documents
What must non-compounding support personnel who perform cleaning procedures be trained in?
hand hygiene, garbing, and cleaning/disinfection
What are qualified health claims?
has to have "not approved by FDA" disclaimer because it did not meet the significant scientific agreement test
States laws must bear a reasonable relationship to public ______, ______, and ______.
health, safety, welfare
How can foreign pharmacy school students graduates able to take the board exam?
may be allowed to take equivalency exam
Brochures, booklets, mailing, bulletins, calendars, and other information distributed to health care professionals by a manufacturer is considered what?
labeling
What is evidence that a product is a drug?
labeling, advertising, and nature of product
The term _____ includes _____.
labeling, labels
What does the third NDC segment identify?
package size and type of drug
What is situation where misbranding is not the same as mislabeling?
package tampering
What is "accompanying" as defined by the courts?
part of an integrated distribution program with a common origin and destination that explains the drug
What is an example of a monopoly?
patents and market exclusivity for new drugs
The FDA has the authority to reclassify devices based on what?
new safety and efficacy information
Are BOP responsible for protecting pharmacists?
no
Are intermediate appellate courts present in all states?
no
Can a pharmacy's right to compound override a manufacturer's patent rights?
no
Can community pharmacies receive samples according to PDMA?
no
Can the judge overturn the jury's decision in criminal cases?
no
Can you put a prescription label on an OTC drug?
no
Do DSs require premarket approval?
no
Do all states allow substitution with B rated products?
no
Do laws and regulations describe all standards of practice?
no
Do states have to reissue a revoked license?
no
Does having a NDC denote FDA approval?
no
Does the FDA have to follow committee recommendations?
no
Is citizenship required for licensure?
no
Is ignorance a defense in the eyes of the law?
no
Must cosmetics obtain premarket approval or conformance with cGMP?
no
Without a prescription, can you advise about an OTC drug for a non-OTC indication?
no
What were medical devices classified as before the Medical Device Amendments (1976)?
drugs
What is the FDA bad ad program?
enlists healthcare professional to help ensure company promotion of prescription drugs is truthful and report those that are not
What equal characteristics must biosimilar products have?
equal MOA, route of administration, dosage form, and strength
Laws are regulation are generally _____ strict for LTCF pharmacy practice.
equally
What did the Poison Prevention Packaging Act do?
established standards for child-resistant containers
Compounding involves _____ _____ medication.
patient specific
The Abigail Alliance decision declared what?
patients do not have constitutional right to investigational new drugs
What is mandatory generic substitution?
pharmacists must substitute a less expensive generic drug unless dispenser writes "dispense as written"
Who composes the BOP?
practicing pharmacists from different areas and consumer members
What does the FDA require to inspect a pharmacy/hospital to determine if the entity is compounding or manufacturing?
probable cause
What is the jurisdiction of state limited jurisdiction courts?
probate, family, juvenile
What did the Food Additives Amendment (1958) do?
required components added to food products receive premarket approval for safety
What did the Prescription Drug User Fee Act (1992) do?
required manufacturers seeking NDAs to pay feeds for applications and supplements, not the public
What did the Color Additive Amendments (1960) do?
required manufacturers to establish safety or color additives in foods, drugs, and cosmetics
What is the general definition of law?
requirements for human conduct applying to all persons within their jurisdiction
What is sterile compounding?
requires maintenance of sterility (free of contamination)
Why is the FDA definition of a drug intentionally broad?
to include almost anything with an intended therapeutic purpose or purpose of altering structure / function of the body so that the FDA can regulate it
What does the Controlled Substance Act allow?
total combined quantity of 50 dosage units that must be transported personally across the border
What is a 503A pharmacy?
traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required)
What is the jurisdiction of state very limited jurisdiction courts?
traffic, small claims
What is a drug sample?
unit of drug not intended to be sold and intended to promote sale of drug
What are some intentionally vague, catchall phrases in pharmacy practice acts?
unprofessional conduct and moral turpitude
Why were people dying prior to the enactment of the Pure Food & Drug Act (1906)?
unsanitary and poorly labeled foods/drugs
Only _____ (in states that allow internet dispensing) are legally permitted to dispense prescriptions via the internet.
verified internet pharmacy practice sites (VIPPS)
Can political subdivisions within a state (ordinances/municipalities) write their own statutes?
yes
Can the BOP discipline a pharmacist's license even if they've been acquitted in court?
yes
Can the reasons to regulate professions be challenged?
yes
Do DS manufacturers have to conform to GMPs?
yes
Do all prescription drugs marketed in the US have to have a NDC?
yes
Do investigational drugs need to be included on the HD list if they meet one of the NIOSH criteria?
yes
Do most states allow CPE exceptions for hardship?
yes
Do the Color Additive Amendments contain a Delaney Clause?
yes
Does ever state require continuing pharmacy education (CE)?
yes
Does every state have its own laws?
yes
Does every state now permit pharmacists to substitute generically in some manner?
yes
Does the jury have to be unanimous in criminal cases?
yes
Is off-label prescribing and dispensing legal under the FDCA?
yes
Is price advertising (reminder advertising) by pharmacies exempt from 502, provided certain conditions are met?
yes
Is product advertising by pharmacies subject to strict liability standard?
yes
Is there a difference between authorization of a refill and transmittal authority?
yes
What is the burden of proof in a criminal case?
"beyond a reasonable doubt"
What must be included on new patient package inserts (PPI)?
-"highlights" section at beginning -table of contents -"full prescribing information" organized to give prominence to most important information -"patient counseling information" section
What is the jurisdiction of the US supreme court?
-9 justices appointed for life -original jurisdiction in cases involving ambassadors, public ministers, consuls, and when state is a party -other cases heard by writ of certiorari
What are the requirements for HD set out by USP <800>?
-HD storage and prep in areas separate from non-HDs -administer HD with closed-system transfer devices -sterile HD need CII BSCs or CACls for PEC -non-sterile HD need externally vented C1 BSC and containment ventilated enclosures (CVEs) -must occur in pressure environment -negative pressure rooms for HD compounding cannot be used for non-HD compounding
What must an herb have to get a monograph?
-FDA approved use OR -USP DI panel recognized use
What is FDA policy on promoting off-label uses?
-FDAMA provides "safe harbor" provisions/guidance that manufacturers can provide written information about off-label uses to healthcare professionals under certain conditions -written information must be in form of journal articles, reference texts, and clinical practice guidelines that have not been influenced by the company -for individual private requests such as by email or telephone, the agency stated that a manufacturer can provide off-label information only to the individual making the request and that the answer should be no broader than the question asked -for public unsolicited requests through electronic media such as websites, discussion boards, and chat rooms, the guidance provides that the manufacturer may provide only contact information and not off-label information. -2014 guidance document is last authority
What does the compounding record include but is not limited to?
-actual lot numbers of ingredients used in prep -expiration dates of ingredients -name of person who prepared it and date prepared -beyond use date
What are the required elements in Rx drug labeling?
-adequate information for use -name/address of manufacturer -name of drug -ingredient information, quantity, proportion -inactive ingredients if not for oral use -statement of generic/proprietary name identity -recommended dosage -"Rx only" -route of administration, if not for oral use -lot/control number -statement directed to pharmacist specifying type of container to be used in dispensing drug -expiration date unless exempted
USP Chapter <800> applies to who?
-all healthcare workers who handle HD -all entities that store, prepare, transport, or administer HD
What did the Generic Drug Enforcement Act (1992) do?
-banned individuals/firms from participating in drug approval process if convicted of related felonies -imposed severe civil penalties for any false statements, brides, failure to diclose material facts, and other offenses
What are some controversies for generics and healthcare practitioners?
-bioequivalence of generics to parent and each other (vary +/- 20%) -whether a drug without market exclusivity for a particular indication could be prescribed and dispensed for that indication
List 11 NTIs.
-carbamazepine -cyclosporine -digoxin -ethosuximide -levothyroxine -lithium -phenytoin -procainamide -tacrolimus -theophylline -warfarin
What are the limits of the law?
-certain human relationships -de minimis violations -protecting individual freedoms while preventing harm to others -punishment must fit crime -society shapes law
There are FDA guidance documents relating standards for what in regards to DTC advertising?
-communications through interactive promotional media -communications through social media platforms with space limitations -correcting third-party misinformation through the internet or social media
What are the requirements for a 503B facility?
-complies with cGMP -permits FDA inspection according to risk based schedule -prohibit the sale or transfer of compounded products by an entity other than the outsourcing facility -compliance with the DQSA labeling requirements -reporting of ADR and compounding information
Where is tax paid alcohol used?
-compounding in community pharmacies -obtainable from outlets that sell liquor at retail
What does it mean when a drug is adulterated?
-contains in whole or in part any filthy, putrid, or decomposed substances. -has been prepared, packaged, or held under unsanitary conditions where it may have been contaminated -manufactured under conditions that do not meet the standard GMP -contains an unapproved color additive -contains a drug recognized in official compendia, but its strength, purity, or quality is lower than the official standards. -container is composed of a deleterious substance that may enter (leach) into the product container.
How does one clean/disinfect sterile compounding facilities?
-dedicated mops, buckets, and disinfecting agents -cleaning should be done from cleanest to dirtiest areas -area to area, within area ceiling-->wall-->floor, within PEC in direction of airflow source --> exit -daily cleaning of work surfaces, counters, floor, storage and shelving, and ceiling
What did the Dietary Supplement Health and Education act (1994) do?
-defined dietary supplements -forced FDA to regulates\ dietary supplements more as food than drugs
What are the principles of interpretation when the courts must interpret statutory law?
-determining legislative intent -ordinary meaning of words -due process rights of the individual
Why is it important to define the practice of pharmacy?
-distinguish from practice of medicine -distinguish pharmacist from ancillary personnel -distinguish pharmacists from unlicensed persons performing pharmacy-related roles
Describe immediate use CSPs.
-emergent use situations -do not need to be compounded in ISO class 5 as long as aseptic technique is followed -no batching or storage -no more than one hour elapses from time compounding to commencement of administration
What did the Medical Device Amendments (1976) do?
-established criteria for classifying devices into one of three categories -required classification of devices according to function, premarket approval of devices, establishing of performance standards, conformance with GMP regulations, and adherence to record/reporting requirements
What did the Food & Drug Administration Amendments Act (2007) do?
-established mandate that FDA develop track and trace standards and SNIs (standardized numerical identifier) -allowed FDA broader use of fees from PDUFU and increased them -established that FDA could mandate labeling changes related to safety, require clinical trial data reporting/registries, require postmarket clinical studies, and require companies to implement REMS -gave FDA authority to require manufacturers to add safety information or warning postmarket
What did the Durham-Humphrey Act (1951) do?
-establishes criteria for distinguishing Rx and OTC drugs -legally establishes oral prescriptions and refills -established that labels of Rx drugs not contain "adequate directions for use" as long as they contain a legend "caution: federal law prohibits dispensing without a prescription" and a pharmacist's label -stated expiration or beyond-using dating on dispensed Rx label required pursuant to state laws
What are medical foods?
-foods formulated for oral or enteral use under supervision of a physician and that are intended for specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation -provide nutritional requirements impossible for patient to meet through normal diet
Describe low risk CSPs.
-for facilities that compound sterile products without a buffer ISO Class 7 area -non-HD substances -administration must be started no later than 12 hours from preparation or as recommended by manufacturer
What are factors courts commonly apply in reaching decisions?
-fundamental notions of fairness -custom or history involved -command of a political entity -best balance between conflicting societal interests
What did the Safe Medical Devices Act (1990) do?
-gave FDA additional authority related to post-marketing requirements and premarket notification/approval for devices -expedited premarket device approval process
What are the requirements for class II medical devices?
-general controls are insufficient alone to ensure safety/efficacy -must meet specific performance standards established by FDA before marketing is permitted -e.g. insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, electric heating pads
What does it mean when products are therapeutic equivalent?
-generic is pharmaceutically equivalent and bioequivalent -generic is pharmaceutically equivalent and expected to have same clinical effect and safety
What dose simple non-sterile compounding involve?
-have USP monograph or appear in peer reviewed journals with specification of all components, procedures, equipment, and stability data -reconstituting or manipulating commercial products with addition of more ingredients
What did the Food & Drug Administration Modernization Act (1997) accomplish?
-increased FDA public accountability -required FDA mission statement to define scope of its responsibilities -required FDA to publish compliance plan in consultation with industry, scientific experts, healthcare professionals, and consumers -creates fast-track process for drugs intended for serious/life-threatening diseases -clarifies pharmacy compounding -replaced "caution: federal law....without a prescription" statement with "Rx only" -warning of "may be habit forming" eliminated -established databank of information on clinical trials -authorized scientific panel to review clinical investigations -expands manufacturer rights to disseminate unlabeled use information -expands FDA authority over OTC drugs and establishes ingredient-labeling requirements for inactive ingredients -mandated priority review for breakthrough technologies in medical devices -established 503a facilities (traditional compounders)
What are some ways the FDA can enforce its regulations?
-injunction -criminal action -seizure of products -warning letters -fines
What are some controversial innovator drug manufacturer practices under the Drug Price Competition and Patent Term Restoration Act (1984)?
-innovator company producing "authorized generics" -30-month stay in ANDA approval awarded when patent holder sues for patent infringement -innovator manufacturer filing of secondary patents, often for product changes and attempt to shift market share to new product (product hopping) -exclusion payments (pay-for-delay agreements)
What can be included in "moral turpitude"?
-intentional acts contrary to honest and good morals -medicaid fraud -DUI
What are some available PEC?
-laminar airflow workbench -compounding aseptic isolator for non-HD materials -biological safety cabinet (BSC) class II
What are the requirements for class I medical devices?
-least potential harm to users -general controls: manufacturers register facility and list their products with FDA, provide premarket notification, maintain records/reports, and adhere to GMP -e.g. needles, scissors, gloves, stethoscopes, toothbrushes
What parts of the three branches of US government actually make laws?
-legislative = legislature -executive = administrative agencies -judiciary = courts
What does the Homeland Security Act permit?
-limits personal importation from Canada for people transporting drugs on their person in a quantity not to exceed a 90-day supply -no controls or biologicals
What must be included in drug labeling?
-list of active ingredients -quantity and listing of inactive ingredients in alpha order -"adequate directions for use" and "adequate warnings against use" by children and other for whom use might be dangerous (OTC drug_ -if drug cannot be labeled with "adequate directions for use", must contain "adequate information for use" (Rx drug)
What did the Nutrition Labeling & Education Act (1990) do?
-mandated nutrition labeling on food products -authorized health claims on product labeling as long as they are made in compliance with FDA regulations
Where is tax free alcohol used (190 proof ethyl alcohol)?
-medicinal, mechanical, scientific, and treatment purposes for inpatients in hospitals -charity clinic mays use for outpatients if they do not charge
Why does the board adopt a broad definition of the practice of pharmacy?
-more latitude to implement regulations -establish professional identity to courts / society
Describe medium risk CSPs.
-multiple doses of sterile products combined or pooled to administer to multiple patients or one patient on multiple occasions -more than 3 commercially available sterile products are used for compound -More complex compounding process (parenteral nutrition)
What are the requirements for class III medical devices?
-must have premarket approval because they are life-supporting / life-sustaining or present potential unreasonable risk of illness/injury -e.g. pacemakers, soft contact lenses, replacement for heart valves
What is an externality?
-when production/consumption of a good affects someone who does not fully consent to the effect -when costs of good are not fully incorporated in the price of good
What is the role of the National Association of Boards of Pharmacy (NABP)?
-overseeing standardized licensing exams -forum for developing professional policies and standards -developing model legislation and regulations for use by member boards
What were some connections givens to innovator drug manufacturers in the PTRA?
-patent-term extensions (longer than initial 20 started at the beginning of drug development) -market exclusivity for an innovator manufacturer that develops a new chemical entity or new use for a previously approved drug (5 years) -generic manufacturer must make patent certification relevant to reference drug
What is described in an herb monograph?
-portion of plant used -botanical characteristics -appropriate assay for procedure for ingredients
What are several reasons for the vast number of marketed unapproved drugs?
-pre-1938 drugs -FDA has yet to remove drugs lacking efficacy after DESI -lax FDA policies on generics approvals prior to 1984 -unscrupulous manufacturers
Describe high risk CSPs.
-prepared from non-sterile ingredients -compounded using non-sterile device prior to terminal sterilization -exposed to conditions worse than ISO class 5 air quality for longer than 1 hour -containing bulk ingredients whose chemical purity and content strength are not verified by labeling and documentation from suppliers or by direct determination -contain or are compounded from sterile contents commercially manufactured products or CSPs without antimicrobial preservatives -prepared by compounding personnel who are improperly garbed or gloved -pre‐sterilization procedures for high risk CSPs such as weighing and mixing shall be completed in no worse than ISO Class 8 environment -must be terminally sterilized before administration to patients
What are exemptions to the Poison Preventing Packaging Act?
-prescriber requests (one medication) -patient requests (blanket request for all meds) -institutionalized patients -certain drug products such as SL nitroglycerin and SL//chewable isosorbide dinitrate -manufacturer may market one size with noncompliant package with an appropriate statement
What are implications of the Dietary Supplement Health and Education Act for pharmacists?
-product selection -education of patients as opposed to promotion of products -restrictions regarding display of DS publications
What did the Virginia decision not bar states from doing?
-prohibiting false/misleading advertising -advertising professional superiority -from making it illegal for pharmacies to offer discounts or rebates
What are reasons to regulate professions?
-protect public from unqualified providers -increase quality of health care -reduce cost of health care -inhibit criminal abuse of drugs
What is the rationale for federal drug regulation?
-protection of public against adulterated and misbranded drug products -necessity of balanced direct regulation with indirect regulation
What did the FDA Safety and Innovation Act (2012) do?
-reauthorized PDUFA -added new user fees for generics and biosimilars -provisions reducing drug counterfeiting -allowed FDA to inspect foreign drug manufacturers -mandated FDA issue guidance on prescription drugs promotion through social media
What are some prohibited acts as they relate to pharmacists?
-receipt or subsequent delivery of an adulterated/misbranded drug -doing of any act which causes a drug to be counterfeit -alternation, mutilation, etc. of the labeling
What did the Compounding Quality Act (2013) do?
-reinstated 503A and thus stripped FDA of new drug authority over compounded drugs -clarified/strengthened FDA oversight over pharmacies engaged in large-scale compounding of sterile products to other licensed entities -entities compounding sterile products may voluntarily register with FDA and comply with cGMP -allows compounders of sterile products to voluntarily register as "outsourcing facilities", and their products will be exempt from misbranding provisions
How do administrative agencies carry out judicial function?
-render decisions pursuant to "hearings" resembling court proceedings -these decisions are subject to judicial review
What can the FDA do if it determines that a device presents unreasonable risk of substantial harm?
-require firms to notify healthcare professionals -recall product -require manufacturer to repair/replace/ refund the purchase price of devices
What does complex non-sterile compounding involve?
-require special training, equipment, facilities, or procedures -includes transdermal or modified release preparations
What are medguides?
-required for drugs FDA has determined as posing "serious and significant concerns" -required for new and refill prescriptions -required for outpatients not under direct supervision of healthcare professional with some exceptions -every new medguide approved since 2007 has been in conjunction with a REMS
What did the Drug Supply Chain Security Act (2013) do?
-required manufacturer serialization of drugs by 2017 -required by 2015 that manufacturers provide transaction info to purchasers, who in turn must provide transaction data to subsequent purchasers (trace and trace) -established timeline for trading partners toward implementation of electronic track and trace system (nov 2023) -established uniform national licensing standards for wholesalers and 3PL providers
What did the Prescription Drug Marketing Act (1987) do?
-required state licensing of wholesalers -banned reimportation of Rx drugs except by manufacturer -banned sale, trade, or purchase of Rx drug samples -mandated requirements for Rx drug samples -prohibited resale of Rx drugs purchased by hospitals or healthcare facilities (unless pursuant to a prescription)
What did the Kefauver-Harris Amendment (1962) do?
-required that new drugs be proved safe AND effective -efficacy requirements made retroactive to all drugs marketed between 1938-1962 -transferred jursidiction of prescription advertising from FTC to FDA -established GMP requirements -added more extensive controls for clinical investigations by requiring informed consent of research subjects and reported of adverse drug reactions
What does moderate non-sterile compounding involve?
-special calculations or procedures required to measure quantities -stability data may not be available
What can be included in "unprofessional conduct"?
-specified, but not inclusive violations -violations that may or may not be related to professional practice of pharmacy
What must be submitted in an ANDA?
-sponsor does not have to conduct clinical studies to establish safety/efficacy -submit sufficient information that generic contains same active ingredient, route of administration, dosage form, and strength as pioneer drug -establish bioequivalence and acceptable manufacturing methods and control procedures
What did the Drug Price Competition and Patent Term Restoration Act (1984) do?
-streamlined generic drug approval process while giving patent extensions -made generic drugs more readily available to public -provided incentives for manufacturers to develop new drugs
What are special dietary foods?
-those supplying a special dietary that exists by reason of a physical, physiological, pathological, or other, condition -infant formulas, artificial sweeteners, caloric supplements
What is track-and-trace, and what is the reason behind it?
-transaction data from very beginning of product life all the way to the pharmacy including every single location that pill or bottle went along the way -prevent counterfeit drug distribution
What must be included on nonprescription drug labeling?
-user friendly format -pharmacological category -principle intended use -cautions and warnings -adequate directiosn for use -"drug facts" panel
What is misbranding?
-when labeling is false/misleading, including healthcare economic information -if drug imitates another drug
What are some controversies involving generic drug labeling?
-whether FDA can approve an ANDA for a generic when lableling will not include one or more of indications contained on the innovator drug product's labeling -whether generic drug manufacturers should be required to change labeling to reflect a known adverse effect
What was Nutrilab, Inc., et al v Schweiker about?
-whether a weight-reduction product (starch-blocker) was a food or a drug, since it was derived frm kidney beans -court found it was a drug because it did not fit the statutory or commonsense definition of food
What is consumer medication information (CMI)?
-written patient information about prescription -not mandated, but recommended by FDA guidance
How do states regulate pharmacy?
10th amendment and police powers
Where does state authority to regulate drugs come from?
10th amendment to US constitution and inherent police powers
Billings and claims submissions require an ____-digit NDC number.
11
The FDA will not take action if a hospital pharmacy distributes compounded drug products without first receiving patient-specific prescriptions/orders provided that...?
1. drug products distributed only to healthcare facilities owned and controlled by same entity that controls pharmacy 2. drug products only administered to patients within healthcare facility pursuant to a patient specific prescription/order 3. drug products compounded in accordance to all other provisions of section 503A
What are three main criticisms of the Dietary Supplement Health and Education Act?
1. prevents FDA from acting aggressively enough to protect public against unsafe DS 2. lack of consumer information about dangers of taking DS with OTC or Rx meds 3. lack quality standards for strength and purity
What are the four types of market failure relevant to regulating drug use?
1. public goods 2. externalities 3. natural monopolies 4. information asymmetry
What did the Virginia decision establish?
1st amendment applies to commercial speech and to recipients of the speech
What two acts allow foods to contain health claims if approved by FDA regulation or "significant scientific agreement"?
1. Nutritional Labeling & Education Act (1990) 2. FDAMA
How long does the President have to return a bill to congress?
10 days
What is the National Drug Code number?
10-digit three segment code that identifies a drug
What are two titles under the Drug Quality and Security Act (2013)?
1. Compounding Quality Act 2. Drug Supply Chain Security Act
What are the four types of patent certifications made in an ANDA?
1. NDA holder did not file information on patent to FDA 2. patent already expired 3. date the patent will explore 4. patent is invalid will not be infringed upon by manufacture, use, or sale of applicant's generic drug
What are three methods to switch prescription drugs to OTC?
1. SNDA - product specific switch 2. petition - product-specific switch 3. adding or amending an OTC drug monograph - affects all products in class
What are six centers in the FDA?
1. center for drug evaluation and research 2. center for biologics evaluation and research 3. center for devices and radiological health 4. center for tobacco products 5. center for veterinary medicine 6. center for food safety and applied nutrition
Outline the different levels of the federal court system.
1. US supreme court 2. court of appeals 3. district courts 4. specialty courts
The Dietary Supplement Health and Education Act permits what four types of nutritional support claims on DS?
1. benefitting a classical nutrient deficiency disease 2. describing role of DS in affecting structure/function of the body 3. characterizing the mechanism by which a DS acts to maintain the structure/function 4. statements of general well-being
What must be included in compounding documentation?
1. master formulation (recipe) 2. compounding record (batch record)
What are the two main branches of the FDA?
1. national headquarters (policy making decisions) 2. extensive field force (local inspection and information acquisition)
Name four items addressed in the Food, Drug, and Cosmetic Act (1938).
1. no new drug could be marketed until proven safe for use 2. required labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs, cosmetics, and devices 3. exempted drugs marketed before 1938 from requirement that new drugs be proven safe more marketing 4. batch certification of safety/efficacy of insulin and penicillin
What are four offices under the FDA commissioner?
1. office of foods and veterinary medicine 2. office of global regulatory operations and poly 3. office of medical products and tobacco 4. office of operation
What three subsections does the new pregnancy labeling (2014) have to include?
1. pregnancy 2. lactation 3. females and males of reproductive potnetial
Why are administrative agencies created?
to administer a body of substantive law
What are two legal special food categories?
1. special dietary foods 2. medical foods
When evaluating government regulation of commercial speech, what four factors must be considered pursuant to the Hudson Supreme Court case?
1. speech must not be misleading or related to unlawful activity 2. government interest in regulation must be substantial 3. regulation must directly advance government interest asserted 4. restriction of free speech cannot be more extensive than necessary to serve that interest
Outline the different levels of the state court system.
1. state supreme court 2. intermediate appellate courts (in more populated states) 3. trial courts 4. limited jurisdiction courts 5. very limited jurisdiction courts
What are the four sources that manufacturers have to offer consumers a method to access to get full labeling information of a drug mentioned in a DTC ad?
1. toll-free number 2. internet webpage address 3. referral to a print advertise in a concurrently running print publication 4. referral to a healthcare providers
Section 502(n) of the FDCA requires all advertisements from manufacturer to contain what two things?
1. true statement of established drug name + formula showing active ingredients 2. brief summary of other information required by regulation
What are three validity tests for a regulation?
1. within scope of board's authority 2. based on statutory authority 3. reasonable relationship to public health, safety, and welfare
How many years of exclusivity does a biologic reference product get?
12
What is the jurisdiction of the federal court of appeals?
12 judicial circuits and courts that hear appeals
What are the CPE requirements in most states?
15 hours annually or 30 hours biennially
A generic company filing a successful paragraph IV ANDA enjoys a ______-day exclusivity period.
180
How many biosimilars are on the market, and how many of them have been deemed interchangeable?
3 biosimilar, none interchangeable
How can congress override a veto?
2/3rds vote
Orphan drugs are used to treat diseases that affect fewer than _______ Americans.
200,000
What are the old pregnancy risk categories?
A - adequate, well-controlled studies that have not demonstrated risk to fetus B - animals studies failed to demonstrate risk to fetus, but there is no adequate, well-controlled studies in pregnant woman C - either animal studies have shown an adverse effect on the fetus or there are no animal reproductive studies, and there are no adequate well-controlled studies in pregnant women D - positive evidence of fetal risk exists based upon data from investigational or marketing experience or studies in humans; however, potential benefits from the drug may be acceptable despite potential risks X - studies in animals or humans have demonstrated fetal risk, and that risk in pregnant women clearly outweighs any benefit
What is the FDA definition of a drug, as define by the FDCA?
A: articles recognized in USP-NF or HPUS B: articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease C: articles other than food intended to affect the structure of function of the body
Generic drugs marketed after 1984 and approved under an ANDA should all have an ____ rating because of what act.
A; PTRA
What is the 2 letter rating system used by the Orange Book?
A____ and B____
Biologics are under the authority of what organization?
FDA (via FDCA)
What act gave the FDA the authority to regulate tobacco products?
Family Smoking Prevention and Tobacco Act (2009)
The Dietary Supplement Health & Education Act only permits DS manufacturers to make health claims if...?
FDA approves claim by regulation or by significant scientific agreement test
How does a biosimilar become interchangeable an interchangeable product?
FDA determination
What is FDA policy on prescription and dispensing of drug for off-label uses?
FDA endorses prescription/dispensing of drugs for off-label use, but NOT pharmacist promotion of said off-label use
Why did the FDA remove Ephedra and Ephedrine Alkaloid?
FDA received long-term adverse event reports
What did the Rx Depot case reveal?
FDA will enforce the "no importation" law against businesses
Name some federal agencies that deal with pharmacy.
FDA, CDC, NIH, EPA, DEA, OIG
What act removed requirements that distributors must submit adverse events reporting to FDA or device manufacturers?
FDAMA
Which act is the nucleus of today's drug laws?
FDCA
What was the outcome of United Sates v Sullivan, 332 U.S. 689?
FDCA has jurisdiction in transactions between pharmacist and patient, even if its within state lines
Who regulates OTC drug advertising?
FTC
What have national pharmacy organization created to oversee accreditation of outpatient pharmacies?
CIPPA
What monitors CPE credit?
CPE monitor, which is provided by NABP
What may pharmacists obtain in many states that allow collaborative practice agreements?
DEA registration
The FDA is housed under what department?
DHHS
What are some state agencies that deal with pharmacy?
DOH, BOP, local government bodies
What did the Pharmanex, Inc. v Shalala case establish?
DSs cannot be specially manufactured to concentrate the natural drug ingredient
What is another name for the Kefauver Harris Amendment (1962)?
Drug Efficacy Amendment
What statutorily created the ANDA for all generic drugs?
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
What citations indicate what court?
F., F.2d, F.3d = federal court of appeals F. Supp. = federal district court U.S, S.Ct. = US supreme court state/region abbreviation = state court opinion
Who can recall devices?
FDA
Who has primary enforcement for administering the FDCA?
FDA
Who is the first NDC segment assigned by?
FDA
Who regulates Rx drug advertising?
FDA
What act established FDA authority to order recalls for certain products, but not drugs?
Food Drug Administration Amendment Act
What is a buffer room?
ISO Class 7 or cleaner area where the primary engineering control is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSP
What are primary engineering controls (PEC)?
HEPA filter and unidirectional airflow
What are three classes of recalls?
I - reasonable probability that product will cause serious adverse health consequences or death II - product may cause temporary or medically reversible adverse health consequences, but probability of serious consequences in remote III - products not likely to cause health consequences
What is the ante room?
ISO class 8 area or cleaner where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate-generating activities are performed
Some states require a separate license for what kind of pharmacies and pharmacists?
LTCF pharmacies and consulting pharmacists
______ has published self-policing guidelines about industry-supported education programs.
PhRMA
What decision may limit FDA's authority to regulate off-label use communications?
U.S. v Caronia, which challenged FDA on grounds of 1st amendment
Where are guidelines for non-sterile compounding located?
USP <795>
What documents specify beyond use dates (BUD)?
USP monographs and standard recipes
What publications have monographs for some botanical herbs?
USP/NF
What is the United States Pharmacopeia / National Formulary (USP/NF)?
USPC publication that sets out uniform standards and drug monographs
By what other name is the Durham-Humphrey Amendment (1951) known?
Waxman Act
What is another name for the Drug Price Competition and Patent Term Restoration Act?
Waxman-Hatch
What is notice and comment rulemaking?
agency writes up initial regulations --> posts for comment in fed. reg. --> holds open public meeting to discuss --> takes comments into consideration --> posts final regulation draft with an effective date
Who issues indictments, and why?
a grand jury when it determines enough evidence exists for an arrest and trial
How does the FDA recruit for committees that advise on guidelines?
academic institutions and openings
What are the required elements in OTC drug labeling?
adequate directions for use + this picture
What is the purpose of the state Boards of Pharmacy (BOP)?
administer state pharmacy practice acts and protect the public
What type of entity is the FDA?
administrative agency
What must BOP comply with in any discplinary action?
administrative procedure laws
What kinds of ads are included in advertising?
ads in journals, periodicals, broadcast media, telephone communications
If the written, printed, or graphic matter pertaining to a drug is not labeling, what is it?
advertising
The FTC regulates food _____, while the FDA regulates food _____.
advertising; labeling
What is the Park Doctrine?
affirmative duty of corporate officers to be aware of and correct violations in their company, as they are responsible for the actions of the company even if they are unaware of their goings-on
In what case would an administrative hearing be applicable?
agency v. private party
What did the Lanham Trademark Act do?
allows private parties a cause of action against false and misleading advertising
What did the Johnson case prompt?
amendment of PFDA to prohibit false and fraudulent efficacy claims
How often is the Orange Book updated?
annually
What are secondary engineering controls (SEC)?
ante room and buffer room
Medical device manufacturers and device-user facilities have to report what about their products?
any deaths or serious injuries related to their products
What is a device?
any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article / component that is A: recognized in USP/NF or HPUS B: intended for use in diagnosis of disease or other conditions, cure, mitigation, treatment, or prevention of disease in man or other animals C: intended to affect the structure or any function of the body of humans/animals but is not food
What are collaborative practice agreements?
authority granted to pharmacists in most states in which an arrangement is made between physician/practice in which a pharmacist can initiate/adjust patient's drug therapy
What is the framework for practice for pharmacists in the eyes of the law?
based upon what a reasonable and prudent pharmacist would do
Ad claims by companies must have a reasonable ____.
basis
What must an appeal be based on?
basis that the court committed an error of law
Why did pharmacists choose to become self-regulating in the 19th century?
because they sell drugs
Why is pharmacy one of the most regulated professions?
because what they sell (drugs) has a high potential for user risk
When does one clean ISO class 5 PEC?
beginning of each shift, before each batch, every 30 minutes when compounding, after spills, and when surface contamination is known/suspected
What is an unofficial third class of drugs?
behind-the-counter drugs that can only be sold from the pharmacy department
What is a criminal case based on?
being charged with a crime as prohibited by a statue and subject to penalties specific by statute
What does interchangeability mean?
biologic can be expected to produce same clinical result at reference product in any given patient
What does biosimilar mean?
biological product is "highly similar" to reference product with no clinically meaningful differences in terms of safety or efficacy
To what type of media is the adequate provision requirement applicable?
broadcast media
What are unqualified health claims?
can be put on without disclaimer because it met the significant scientific agreement test
What are the 6 criteria used to identify a hazardous drug?
carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, organ toxicity at low doses, and drugs that mimic existing drugs in structure/toxicity
In what two areas are regulations increasing?
compounding and PMP
What are state legislatures generally modeled after?
congress
What must a food manufacturer submit to support obtain FDA approval of its drug claim?
considerable evidence to support the claim
The FDA allows manufacturers to apply the adequate provision requirement, provided what?
consumer is offered full labeling information from one or more of four sources (FDA recommends all)
What is one type of non FDA-reviewed written information that pateints may receive with their prescription?
consumer medication information (CMI)
Who administered the Poison Prevention Packaging Act?
consumer product safety commission
What does pharmaceutical equivalence mean?
contain same active ingredients and are identical in strength and dosage form
Some states have enacted what kind of laws to help increase regulation for outcomes?
continuous quality improvement (CQI)
FTC has the authority to require _____ _____.
corrective advertising
What are other names for state trial courts?
county courts, superior courts, district courts, circuit courts
What was the verdict in North Dakota State Board of Pharmacy v Snyder's Drug Stores Inc.?
court ruled state statute that prevented Snyder's from opening a pharmacy where the majority owners were not pharmacists unconstitutional
What happens during judicial review of administrative agency judicial function?
court will review record to determine if decision was based on substantial evidence, and if substantial evidence lacking, court will conduct entirely new trial
What is a judicial opinion?
decisions of the court that are enforceable as law
Who can appeal in criminal cases?
defendant (NOT the government)
What is a plea bargain?
defendant agrees to lesser charge rather than face trial
How does a criminal trial start?
defendant either indicated or arrested
What is the International Organization for Standardization?
defines max acceptable particulate matter and size of matter allowable per cubic meter within air of area
Are there term limits for BOP members?
depends on state
How has the definition of the practice of pharmacy evolved?
dispensing focused --> professional service / clinical actions focused
What is strict liability?
do not need intent to be liable
What does an rating that starts with A mean?
drug considered therapeutically equivalent to reference drug product
What does a rating that starts with B mean?
drug not considered therapeutically equivalent, quality standards are inadequate, insufficient data to determine therapeutic equivalence, drug product still under review
What did the old pregnancy labeling have to include?
drugs potentially risk during pregnancy be placed into one of five categories (A, B, C, D, X)
What are narrow therapeutic index drugs (NTI)?
drugs with less than a two-fold difference between MTC and MEC
What is a PMP?
electronic program in which all of a patient's controlled substances prescription are reported and monitored by pharmacists and prescribers
In most states, students are allowed to become interns starting when?
first year of pharmacy school
When may manufacturers publish professional OTC labeling?
for indications not appropriate for lay diagnosis/treatment
In what situations may investigational drugs be used for treatment outside of the clinical trials?
for patients with serious or life-threatening disease for which no comparable or satisfactory alternative therapy is available
Are misbranding and mislabeling interchangeable?
for the most part
What must compounding personnel be trained in?
garbing, aseptic technique, maintaing iso class 5 environment, cleaning and disinfection
What do most state biosimilar laws allow?
generally permit substitution, provided the prescriber has either authorized or not prohibited substitution, and that the prescriber is notified of the substitution
Is license transfer allowed by every state?
generally, but not guaranteed if you've had problems in another state
What are the patent considerations of an ANDA?
generic manufacturer must make one of four types of patent certifications
Labeling must accurately differentiate between _____ and ______.
generic; brand
Every state permits pharmacists to substitute ______ in some manner, but state laws differ ________.
generically; considerably
Some state laws have not kept up with significant changes in _____ pharmacy.
hospital
PPI distribution laws apply to _____ pharmacy, not just _____ pharmacy.
hospital; community
What do standards of practice determine?
how/where pharmacy is practiced and who can practice
Law Abbreviation Hell
https://quizlet.com/192223204/law-abbreviation-hell-flash-cards/
What is an interchangeable biologic product?
if FDA deems biosimilar therapeutically equivalent to reference product
What is not a true statement?
if advertising is false or misleading, doesn't present a fair balance between effectiveness and side effects/contradictions, and reveals all fails to reveal all material facts
When may containers be reused, according to the PPPA?
if containers are glass or threaded plastic, and only with a new closure
States vary in regards to what for their CPE requirements?
if hours must be live, approved by ACPE, or on a specific subject
When will the FDA not regulate a product as a medical device?
if intended for general wellness, has low risk, and makes no references to diseases/conditions
When may the FDA remove cosmetics from the market?
if misbranded, adulterated, or a health hazard
What are the implications for a drug if it is recognized in USP/NF or HPUS?
if must meet all standards of the compendia
When may individual patients acting through a physician request an investigational drug?
if physician determines patient has no comparable or satisfactory alternative and the risk from the investigational drug is no greater than the risk of the disease
When can a cosmetic becomes a drug?
if seller makes a health or structure/function claim
When would a pharmacist not be subject to penalties?
if the pharmacist sells the drug in good faith and on request furnishes the FDA with information about the source of supply
What is the FDA inspection authority?
if they have probable cause that pharmacy is manufacturing (no warrant required)
What is standard for cosmetic safety?
ignorant/uninformed consumer could use it and won't be hurt
What is the FDA's compassionate use policy?
importation of small amounts of drugs, but only if they are approved in the US and are used for the treatment of a serious condition for which no satisfactory treatment is available in this country
For what reasons would the drug approval process be expedited?
in the case of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for the condition AND have an effect on a clinical endpoint predictive of clinical efficacy
How are trial court opinions reported?
include names of parties involved, citation to indicate which court decided the case and the volume/page number where its record can be found
What are some examples of externalities?
indiscriminate use of antibiotics
Commission of any of the listed offenses in Section 301 of the FDCA violates the FDCA, regardless of the person's ______ or ______.
intentions; knowledge
Where does federal authority to regulate drugs come from?
interstate commerce clause of US constitution
The FDCA excludes an articles as a DS in what situation?
it was approved as a drug prior to being marketed as a DS
Why should USP standards be followed?
joint commission requires USP adherence, and its the group that accredits hospitals, so its kind of a big deal
What happens after an arrest?
judge must determine at a preliminary hearing if there is enough probable cause for an arrest, and if so the defendant must enter a plea at an arraignment
What is common law?
judicial opinions
In an effort to free pharmacists for more professional services, some states have authorized the use of _____.
kiosks
What is the path a bill takes to become a law?
legislator sponsors bill --> bill sent to appropriate congressional committee in either house or senate --> house/senate committee holds hearings, conducts investigations, and determines whether bill will go to house/senate floor --> once bill is approved by either house/senate, the process is repeated in the other wing of congress
Who creates administrative agencies?
legislature
Conflicts generally exist when state law is ____ strict than federal law.
less
What must be included on cosmetics labeling?
list of ingredients in descending order of predominance and appropriated warning
What power does the 10th amendment to the constitution give to the states?
make laws that are not specified by federal government, as long as these do not attempt to supersede federal law
What did the Federal Anti-Tampering Act (1982) do?
makes it a federal offense to tamper with consumer products
How can a pharmacy get back a revoked license?
making application to the BOP for reinstatement and showing that the problem that originally led to revocation is no longer operative
What is the Physician Payment Sunshine Act (included in ACA)?
mandates disclosure by drug/device manufacturers and group purchasing organization in the DHHS of nontrivial payments to physicians and teaching hospitals from industry-supported education programs
If not an outsourcing facility (503B) or a 503A pharmacy, the FDA will classify an entity as a _____.
manufacturer
Who assigns the second and third NDC segments?
manufacturer
Whose responsibility it is to dispense medguides to patients for drugs requiring medguides?
manufacturer and dispenser
What does the first NDC segment identify?
manufacturer/distributor
Pharmacies that relabel or repackage must conform to same labeling standards as _____.
manufacturers
In the event of a recall, who is responsible for notifying who?
manufacturers responsible for notifying seller, and seller for notifying consumers if necessary
What are two types of FDA-reviewed written information that patients may receive with their prescription?
medguides and PPIs
Compounded drugs are exempt from new drug provisions provided the pharmacy...?
meets all conditions established in FDAMA
What type of environment is needed for sterile compounding?
minimizes any potential for contamination of product they're creating
Failure to distribute PPIs is considered what?
misbranding
Promotion of off-label use by pharmacists and sales persons is ______.
misbranding
What is it called if a drug doesn't have a label or it has an incorrect label?
misbranding and mislabeling
If a medication has a brand name label, but you dispense the generic, what is that considered?
misbranding and mislabelling
What did United States v Johnson, U.S. 488 hold?
misbranding provisions did not prevent false/misleading efficacy claims
What happens if a drug does not meet all compendium standards in the USP-NF or HPUS?
misbranding/adulterated
What is compounding?
mixing, altering, or assembling a drug and other ingredients
How does one differentiate between a drug and a biologic?
mode of action
Why do we make standards of practice into laws or regulations?
more easy to enforce
Who developed USP Chapter <800>?
national institute for occupational safety (NIOSH)
What are public goods?
necessary and beneficial commodities that private entities will not supply because there is no incentive
What is the BUD for water containing oral formulations?
no later than 14 days at controlled cold temp
What is the BUD for water containing topical/dermal liquid, mucosal liquid, or semisolid?
no later than 30 days
What is the BUD for a non-aqueous formulation?
no later than time remaining until earliest expiration date of an active pharmaceutical ingredient, or 6 months, whichever is earlier
Does the board HAVE to revoke/suspend a license of a pharmacist who voluntarily comes forward to the impaired pharmacist program?
no, BOP discretion used
What did the Patient Protection and Affordable Care Act (2010) do?
obamacare
If a manufacturers obtains NDA approval for an unapproved marketed drug, all marketed drugs in the same class but do what?
obtain NDA approval within one year
On what basis can the FDA remove a DS from market?
on the basis of public safety if it can prove the product is adulterated
What is a label?
on the immediate container or wrapper of any article
What is indirect regulation?
people regulating their own decisions with gov providing accurate/useful information through labeling
Many states allow interns to do what?
perform any function a pharmacist can perform, under the direct supervision of a pharmacist
On what conditions do some states allow the only pharmacist on duty to take a break off the premises?
pharmacist and PIC remain responsible for actions of ancillary personnel
What have courts upheld in relation to a pharmacist's conscientious objection?
pharmacist cannot obstruct a patient's legal right to receive medications, but that state regulations requiring pharmacists to dispense violate first amendment rights
Most states pharmacy owner to name a _____.
pharmacist in charge (PIC)
Why is there a issue about whether a Rx must be checked by a pharmacist when dispensed in an automated system?
pharmacist is ultimately responsible for any errors make by automation
What is permissive generic substitution?
pharmacist may choose to substitute if prescriber issues the prescription in a way that permits substitution
Depending on the situation, BOP can take disciplinary action against ...?
pharmacist, pharmacy, or both
Prescription bulk drug labels are meant for whom?
pharmacists
What do some state laws require to prevent pharmacist errors?
pharmacists get meal break of at least 30 minutes
From what phases can investigational drugs be used outside of clinical trials for?
phase 3
Drug expedition is conditional upon the manufacturer agreeing to what?
phase 4 testing
Who's name appears first in the title of a civil case?
plaintiff
What HPCUS is a _____ organization.
private
What is scope of practice?
practitioners authority to perform actions in their field of practice, as determined by state
What FDAAA has provided FDA with the authority to require _______ of ads, but it can only provide _____ to companies.
pre-review; recommendations
Many states prohibit ______ from owning a pharmacy.
prescribers
What is the adequate provision requirement?
prescription drug advertising in broadcast media need only include summary of major risk information instead of full "brief summary" provided that manufacturer makes "adequate provision for the dissemination of approved package labeling"
What are some examples of information asymmetry?
prescription-only drugs and written consumer information for certain drugs
Who appointments the FDA commissioner?
president
What is a pocket veto?
president doesn't sign veto but congress adjourns before 10 day s
What is the jurisdiction of state trial courts?
pretty much unlimited
The USPC works closely with the FDA, but is _____.
private
Cosmetic manufacturers must substantiate ____ ____.
product safety
What are biologics?
products derived from living organisms
What does bioequivalence mean?
products display comparable bioavailability (rate and extent of absorption) at the site of action under similar conditions
What should pharmacists exercise when called upon to substitute B-rated NTI drugs?
professional judgment
What does the Federal Trade Commissions Act allow the FTC to do?
prohibit deceptive ads and regulate advertising for food, OTC drugs, and medical devices
What is the law on internet pharmacy in many states?
prohibit dispensing prescriptions via internet unless they were issued pursuant to a good faith prior examination by a prescriber
What does the first amendment restrict in regards to commercial advertising?
promotional activities by product sellers falls under the 1t amendment (freedom of speech), but also recognized need for government regulation of commercial activities
How do administrative agencies make laws?
promulgate regulations that interpret, define, and add detail to statutes
How does the FDA have rulemaking authority?
promulgation of regulations
How are biologics and biosimilars named?
proprietary name that includes FDA-designated suffix
What was the purpose of the Poison Prevention Packaging Act?
protect children from accidental poisonings due to "household substances"
What does FDAAA require pharmacies to do regarding medwatch?
provide patients with medwatch number and statement about reporting side effects
What did the Orphan Drug Act (1983) do?
provided tax and exclusive licensing incentives for manufacturers to develop and market orphan drugs and biologicals
What is the Homeopathic Pharmacopeia of the United States?
publication by HPCUS that sets standards for homeopathy products
What is the name of the book that lists biosimilars and interchangeable products?
purple book
What did the Biologics Price Competition and Innovation Act create?
regulatory framework for biosimilars or "follow on" biologics
What is the purpose of impaired pharmacist programs?
rehabilitate pharmacists, rather than punish them, for alcoholism and drug abuse
What kinds of ads are exempt from adequate provision requirements?
reminder and help-seeking ads
Pharmacist licenses are subject to periodic ______.
renewal
The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers to do what?
report serious AEs
What is a veto?
return bill with reasons for dissaproving
Under the Food, Drug, and Cosmetics Act (1938), the FDA had no authority to do what?
review medical devices for safety and efficacy
Off-label prescribing and dispensing requires professional evaluation of ______ v _____.
risk; benefit
What does fair balance mean?
same scope, depth, and detail of info be presented for side effects/contraindication as for effectiveness
Who does the FDA commissioner report to?
secretary of DHHS
Who has the actual authority for administering the FDCA?
secretary of DHHS
Who confirms the FDA commissioner?
senate
What are three levels of non-sterile compounding?
simple, moderate, and complex
What is excluded from the definition of cosmetics?
soap
Why do drugs that are both OTC and prescription exist?
some indications can be labeled with "adequate directions for use" (OTC), while some cannot (Rx)
Labels for herbs must contain what?
standard common names as listed in the Herbs of Commerce (reference source)
What were state pharmacy law and regulations before they became a law?
standards of practice
Guidance documents incorporate advice from who?
standing advisory committees of outside experts
Who defines prescriptive authority?
states
Describe the licensing of non-resident pharmacies.
states can require registration, but don't necessarily require they be held to same requirements as in-state pharmacies
How do legislatures make laws?
statutes (statutory law)
What are some examples of medical devices?
stents, pumps
What is the BUD for CSPs determined by?
sterility limits and chemical stability
What are section 505(b)(2) NDAs used to file for?
streamlined drug approval process for certain drugs and generic approvals that do not want to go through full NDA or ANDA (can rely on published
What does the second NDC segment identify?
strength, dosage form, formulation
Violation of the FDCA is subject to ______ ______, but what can be an applicable excuse (not often, though)?
strict liability; good faith
How does a manufacturer obtain a license to sell a biologic?
submit biological license app (BLA) that includes evaluation of purity, safety, and potency
What is the FDA biosimilar substitution law?
substitution allowed when FDA determines product is interchangeable
What was the catalyst for the Food, Drug, and Cosmetic Act (1938)?
sulfanilamide poisonings
What is the nature of a product dependent on?
supplier's intended use, NOT the buyer's
What allows federal law to preempt state law when they conflict?
supremacy clause of US constitution
What is the jurisdiction of federal specialty courts?
tax court (taxes), customs court (customs), customs and patent appeals court (appeals from customs court), claims court
Some states have developed a _____ _____ _____ approach in hospital pharmacies.
tech-check-tech
What type of pharmacy has caused states problems concerning how they should be licensed?
telepharmacy
What drug was the catalyst for the Kefauver-Harris Amendment (1962)?
thalidomide
What are some concerns about industry-supported educational programs?
that programs be independent from promotional influence and objective
Who is the plaintiff in criminal cases?
the government
What does OTC drug review approve drugs based on?
therapeutic category and conformance to a monograph (rather than on a drug-by-drug basis like prescription drugs)
What is not described in an herb monograph?
therapeutic use
Contrary to the DSHEA, in Pearson v. Shalala, the courts held that DS manufacturers could make health claims not approved by the FDA provided...?
they are not false or misleading, and they are accompanied by a disclaimer
How many unapproved drugs does the FDA estimate are on the market today?
thousands
What kind of airflow must e present in a PEC?
unilateral with sufficient velocity to sweep particles away from compounding area
What are DSs?
vitamin, mineral, herb, other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
What are two pathways into impaired pharmacist programs?
voluntary and involuntary as ordered by BOP
What is medwatch?
voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues
What is information asymmetry?
when consumer is uninformed about the true value of a good
When do common and statutory law merge?
when courts have to interpret meaning/application of statutes
What is a monopoly?
when fixed costs of providing a good are high relative to variable costs of producing the good
When are ads deceptive?
when they contain a statement (or omission) of information that is likely to mislead reasonable consumers to their detriment
To what transactions does the Drug Supply Chain Security Act apply to?
where prescription drugs change ownership
What is conscientious objection as it relates to pharmacists?
whether pharmacist has right to refuse to dispense prescriptions when a moral or religious objection exists
What does the Medicare Modernization Act allow?
wholesale importation of Rx meds from Canada provided Secretary of DHHS would approve
Can pharmacists and sales people disseminate requested scientific information to doctor in the absence of promotion?
yes
Where do state laws apply?
within the state they were enacted in
What is labeling?
written, printed, or graphic matter "accompanying" a drug article
Are HD products received and stored separately from non-HD?
yes
Are bioequivalent products generally presumed to be therapeutically equivalent?
yes
Are pharmacists responsible for knowing of product recalls and notifying patients of recalls?
yes
Are unit dose labeling subject to different information requirements than regular commercial labels?
yes
Can certain devices be available by prescription only?
yes
Can interchangeable products be substituted for reference products without intervention of the healthcare provider who prescribed the reference product?
yes
Is off-label use acceptable symposia content?
yes, as long as there is disclosure that the use is unapproved
Do all states allow pharmacies to advertise drug prices?
yes, because of the virginia decision
If there is no buffer area, can sterile compounding still occur?
yes, but air in PEC must still be ISO class 5, and only low risk compounds can be made
Does revocation of your license in one state serve as a basis for revocation in another state?
yes, if the revocation was warranted
