Law exam 1 Flashcards

Question

Safe Medical Device Act

Answer 1

- makes sure that medical devices are safe 1- Made the FDA have additional authority for post-marketing requirements and premarket notification 2- also allowed for approval while speeding up the premarket device approval process.

Answer 2

- made it so that generic drugs are used instead of brands because they are cheaper 1- Occurred when some FDA staff accepted bribes from generic drug industry workers to facilitate the approval process of certain generic drug products. 2- The FDA banned individuals or firms from participating in the drug approval process if convicted of related felonies. 3- Impose severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.

Answer 3

- allowed the FDA to collect user fees from an ultimate user of drugs 1- The FDA and Congress took the approach that private industry should handle part of the costs for new drug approval rather than the taxpayers. 2- Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies. 3- Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review.

Answer 4

- expedited important drugs such cancer, reproductive etc 1- Due to FDA criticism, the FDA was not efficiently administrating its statutory responsibilities, and the FDCA was too burdensome a regulatory system for drug approval. 2- FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. 1- The intent is to eliminate backlogs in the approval process and ensure timely review of applications. 2- Creates fast fast-track approval process for drugs intended for serious or life-threatening diseases 3- Establish a database of information on clinical trials, authorize scientific panels to review clinical investigations, and expand the rights of manufacturers to disseminate unlabeled use information. 4- Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.

Answer 5

- drugs are now under surveillance to make sure that they are not being abused or harmful in any way 1- clarifies and strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities. 2- The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling, and the new drug approval process. 3- title 1 also called the Compounding Quality Act 1- adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products. 2- Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers. 3- The law also mandates an electronic, exchangeable product tracing system by 2023, strengthens wholesaler and third-party logistics licensure requirements, and requires manufacturers to serialize drugs by 2017. 4- Title II known as the Drug Supply Chain Security Act,

Answer 6

- safe and effective drugs 1- FDA’s broader use of the fees generated from PDUFA, substantially increased fees 2- In response to postmarket problems with certain drug products (i.e. Vioxx), the law provides the FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting, and registries, requiring postmarket clinical studies to assess risk 3- requires companies to implement risk evaluation and mitigation strategies (REMS).

Answer 7

1- enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.

Answer 8

allowed every one to have affordable insurance Created insurance option for poor, elderly and less for fortunate people

Answer 9

article recognized in compendia Article the mitigates, treats and prevents disease

Answer 10

food drug administration All drug approvals go through them

Answer 11

- excludes articles that elicit their effect through chemical and or biological effect

Answer 12

alters appearance, for cleansing

Answer 13

any nutritious substance that people or animals eat or drink or that plants absorb in order to maintain life and growth.

Answer 14

therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

Answer 15

- DSs are used to replace food and can be vitamins, amino acids, minerals, herbs etc

Answer 16

The term labeling includes labels. Labeling is defined as written or printed or graphic matter “accompanying” the article. Courts have defined accompanying. If the written, printed, or graphic matter is not labeled, it is advertising.

Answer 17

USP - Published by the USPC - Sets uniform standards - USPC works closely with the FDA but is private. HPUS - Publishes standards for homeopathy products by the HPCUS, a private organization - Role and legal authority of HPUS Pursuant to FDCA, if a drug is recognized in USP or HPUS, the drug product must meet all standards of the compendia.

Answer 18

Adulteration Misbranded Violation of FDCA is subject to strict liability - Good faith excuse applicable Most prohibited acts involve misbranding or adulteration.

Answer 19

Adulteration provisions focus on both the facility and the product. A pure drug may be considered adulterated based on the facility. A drug is adulterated if its strength, quality, or purity differs from compendia standards unless plainly stated on the label. A drug is adulterated if its strength, quality, or purity differs from the label. A product is adulterated unless manufacturer complies to CGMP. CGMP is an exhaustive set of standards directed at manufacturers. The failure to manufacture a product in a tamper-resistant container when required by law is adulteration and also misbranding. Pill falls on the floor

Answer 20

Labeling must not be false or misleading, including healthcare economic information. Labeling must include a listing of active ingredients and quantity and a listing of inactive ingredients in alpha order. Labeling must contain “adequate directions for use” and “adequate warnings against use” by children and others for whom use might be dangerous. If a drug cannot be labeled with “adequate directions for use,” it must contain “adequate information for use.” It is misbranding if a drug imitates another drug. The package promises hair growth and does not do that at all

Answer 21

- impacts the trustworthiness of pharmacy to hold to its word and deliver what it says that it would

Answer 22

1- drug poses lethal effect 2- the drug has ADR 3- drug labeling violation The FDAAA established the FDA authority to order drug recalls for certain products, but not drugs. Three classes of recalls Manufacturers are responsible for notifying sellers; sellers are responsible for notifying consumers, if necessary Pharmacists responsible for knowing of product recalls

Answer 23

Is illegal Must be evident by the packaging and manufacture must provide product tamper evident packaging to ensure that the product is not tampered before getting to ultimate user

Answer 24

Commercial Container label 77 Unit Dose Label 77 ?

Answer 25

Black Box Warning Pregnancy Warning ?

Answer 26

- highest level of warning that can be given Required in labeling when use of a drug may lead to death or serious injury Required for many prescription drugs

Answer 27

- placed with package to warn against drugs affecting pregnancy, lactation, reproduction, etc The labeling system prior to June 30, 2015, required that drugs potentially risky during pregnancy be placed into one of five categories: A, B, C, D, and X. A- no harm X- harm A 2014 regulation replaces the above system. For drugs approved after June 30, 2015, labeling will require the inclusion of three subsections to describe risks: “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” Drugs approved prior to June 30, 2015, will be gradually phased into the new labeling standards.

Answer 28

National Drug Code Number Manufacture, product, package 10-digit three segment code (4-4-2, 5-3-2, or 5-4-1) The first segment identifies the manufacturer or distributor; the second identifies strength, dosage for, and formulation; the third identifies package size and type of drug. Billings and claims submissions require an 11-digit NDC number.

Answer 29

formulation/ early formulation: extracting the molecule or chemically creating it Preclinical trials: testing the molecule in rodents Apply for the IND to test it in humans phase I: test the safety Phase II: test the efficacy Phase III: test the safety and efficacy New Drug Application (NDA) Process IND Investigational New Drug Application The sponsor must receive an approved Notice of Claimed Investigational Exemption for a New Drug to ship the drug in interstate commerce to conduct phase 1, 2, and 3 clinical studies. The FDA may terminate testing at any time under risk–benefit criteria; the decision is not subject to an appeal or judicial review. The FDAAA requires NDA sponsors to publish summary information regarding phase 1 trials on a public registry. The FDA has 180 days to act on a completed NDA, but delays are common. Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio. The applicant may judicially appeal a rejected NDA, but success is very unlikely.

Answer 30

one that has not been previously recognized in the pharmacopeia Has new substance is defined as a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in labeling.

Answer 31

- when it passes all the clinical trials and is approved by the FDA An approved drug can become a new drug under certain conditions: - Addition of new substance - New combination of approved drugs - Change in proportion of ingredients - New intended use - Dosage, method, or duration of administration or application is changed

Answer 32

- should be received from the subjects of the study Informed consent is required in all three phases of the clinical trial Research subjects are required to know the risks, possible benefits, and alternative courses of treatment Institutional Review Board (IRB) approval required in some settings

Answer 33

- is applied for after all of the trials to be approved by the FDA as a new drug The FDA has 180 days to act on a completed NDA, but delays are common. Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio. Applicant may judicially appeal a rejected NDA, but success is very unlikely.

Answer 34

- rating drugs based off of therapeutic ability and not just by name A priority classification system rates new drugs by chemical type and therapeutic potential; this determines how quickly the drug will move through the IND/NDA process. A number designates chemical type, and a letter (S, P, or O) designates therapeutic potential.

Answer 35

I: Safety II: efficacy III: safety and efficacy

Answer 36

The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks. Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.

Answer 37

- generics were created to compete with the production of brands Statutorily created the ANDA, expediting generic approval Concessions to innovator drug companies included: - Patent extensions - Market exclusivity

Answer 38

- Reviewing OTC for acceptable use by the public The OTC drug review process approves drugs on the basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basis like prescription drugs.

Answer 39

- medicinal entities from biological organisms Products derived from living organisms Licensure by PHSA, but subject to FDCA and FDA requirements The Biologics Price Competition and Innovation Act created a regulatory framework in 2010 for biosimilars or “follow-on” biologics. The FDA Purple Book lists biological products, including any biosimilar and interchangeable biological products.

Answer 40

- health care professionals keeping an eye on how the drug is doing in their patient and reporting any ADR to the FDA Voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues The FDA emphasizes the importance of reporting by healthcare professionals. The FDAAA requires pharmacies to provide patients with the MedWatch number and a statement about reporting side effects.

Answer 41

- excludes articles that are used to implement a chemical effect on a patient

Answer 42

- used to cleanse and or alter appearance The definition of cosmetic generally includes topical articles intended for cleansing, beautifying, or altering appearance. A cosmetic can become a drug if the seller makes a health or structure/function claim. “Ignorant, unthinking consumer” standard likely applied Some products can be both cosmetics and drugs. No premarket approval, nor conformance with CGMP Manufacturers must substantiate product safety. The FDA may remove if misbranded, adulterated, or a health hazard. Must be labeled with list of ingredients in descending order of predominance and appropriated warnings

Answer 43

- drugs that are very similar to the reference but pose more side effects

Answer 44

- done to sell drugs on the market The FDA regulates Rx drug advertising, and FTC regulates OTC drug advertising. The First Amendment restricts government regulation of commercial advertising. Any regulation will be evaluated pursuant to the four factors established by the U.S. Supreme Court.

Answer 45

- for physicians to advertise drugs

Answer 46

- using a drug for anything other than the accepted use from the FDA

Answer 47

marketing targeted directly toward a consumer

Answer 48

Prohibits use of any false description or representation Allows for private cause of action and recovery of monetary damages

Answer 49

RX vs OTC Written vs oral vs electronic Labeling requirements Exempts the pharmacy label on dispensed drugs from Section 502, except for certain provisions Specifies the minimum information that a dispensed Rx label must contain Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws Establishes criteria for distinguishing prescription drugs from OTC drugs Legally establishes oral prescriptions and refills Although the amendment did not contemplate electronic prescriptions, other federal and state laws permit them.

Answer 50

name, address, DOB of patient Prescribers name, address, phone # and DEA #

Answer 51

- need to be on label Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws

Answer 52

- needs to be on the label Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws

Answer 53

Manufacturer SNDA Manufacturer petition FDA FDA add or amend Three methods: - SNDA: product-specific switch - Petition: product-specific switch - Adding or amending an OTC drug monograph: affects all products in the class

Answer 54

behind-the-counter drugs Intended to be only sold in a pharmacy Pseudoephedrine Naloxone Emergency contraceptives Refers to creating a class of drugs that can only be sold from the pharmacy department Rationale based on the fact that more dangerous drugs are being switched and would allow even more to be switched Historic opposition to the FDA appears to be shifting

Answer 55

Distinguish authorization of refill from transmittal authority

Answer 56

- federal allows state to decide Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice. Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.

Answer 57

- initially, Plan B was for Rx only and now it is moved to OTC Plan B approved in 1999 as Rx only Citizen Petition in 2001 requesting switch to OTC status without age restriction followed by SNDA requesting the same in 2003 After initial rejection of Barr’s SNDA, the FDA finally approved the drug in 2006 as OTC in women 18 and older and only sold behind the counter of pharmacies. FDA denied Citizen Petition in 2006 prompting Tummino lawsuit, where judge found FDA abused its discretion Judge ordered age reduced to 17 and FDA to reconsider petition In 2011, Teva submitted SNDA for drug as OTC without age or point-of-sale restriction. FDA Commissioner approved SNDA to eliminate age restriction in 2011; overturned by secretary of DHHS The FDA again denied the Citizen Petition leading to another Tummino decision in 2013 where the court reversed the FDA’s decision and ordered the FDA to make Plan B OTC without restrictions. The FDA ultimately declined to appeal and approved Plan B One-Step as an OTC drug without restriction.

Answer 58

- an RPh can refuse to give medication if it goes against their ethical beliefs Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists States have passed laws or regulations addressing this issue. Courts have held that a pharmacist cannot obstruct a patient’s legal right to receive medications. State regulations requiring pharmacists to dispense except in certain situations have been upheld.

Answer 59

- RPh & MD agree to collaborate together Authority granted to pharmacists in most states

Answer 60

MD- under certain cases if the state allows RPh- most of the time Depends on state law The FDA does not believe D-H dispensing standards apply to prescribers; however, most states regulate prescriber dispensing in some manner. Medications may only be dispensed by a physician, pharmacist, or registered nurse. The act of administering medication involves giving the client a single dose of prescribed medication. All personnel who are licensed to do so may administer medications.

Answer 61

includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug.

Answer 62

- both must be included as a black box warning and or pregnancy warning in the package to be given Although the FDA originally had wanted PPIs required for most drugs, it applies to very few, including estrogen-containing drugs, DES, and oral contraceptives. Duty of manufacturers and pharmacists to distribute to patients Law applies to institutional pharmacy as well as community.

Answer 63

- can be given with the package to educate ultimate user on how to take medication Required for drugs FDA has determined as posing “serious and significant concerns” Required for new and refill prescriptions Generally required for outpatients not under direct supervision of healthcare professional with some exceptions Content of MedGuide must be approved by FDA Every new MedGuide approved since 2007 has been in conjunction with a REMS. FDA proposing a single page information document

Answer 64

- like a med. guide, should be included with the package in order to educate patient on what they are taking

Answer 65

The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks. Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.

Answer 66

Quetiapine (Seroquel) for Insomnia. ... Drug products commonly prescribed for off-label uses Off-label prescribing and dispensing is legal under FDCA. Off-label prescribing and dispensing requires professional evaluation of risk vs. benefit. Courts generally regard labeling as evidence toward the standard of care and not as prima facie establishing the standard of care.

Answer 67

applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility. Section 503B applies to human drug compounding within an outsourcing facility.

Answer 68

not recognized in the pharmacopeia

Answer 69

- a nation wide security system that is used to monitor how drugs are being used for medicinal purposes

Answer 70

- given like a med. guide or package insert

Answer 71

503: - compounds to accommodate patient-specific prescriptions and is required by the state boards of pharmacy to comply with USP 797 Guidelines. 503A pharmacies are not permitted to distribute for office use, nor are they permitted to compound large batches of product. 797: - sterile compounds 795 - nonsterile compounds

Answer 72

State generic substitution laws - Every state permits pharmacists to substitute generically in some manner. - State laws differ considerably. - Labeling must accurately differentiate generic products from brands. 503A FDAMA (Section 503A) 1997 - Defined compounding and delineated nine activities that might cross the line from compounding to manufacturing; added other requirements regarding compounding - Stripped FDA of authority to consider compounded drugs as “new drugs”

Answer 73

Examples FDA Stance Drugs with less than a two-fold difference between the median lethal dose and median effective dose or a two-fold difference between minimum toxic concentrations and minimum effective concentrations Controversy exists as to whether the FDA’s statistical parameters for bioequivalence are accurate enough for certain NTI drugs; the FDA drafted new guidelines. Pharmacists should exercise particular professional judgment when called upon to substitute B-rated NTI drugs.

Answer 74

Drug Samples Registration of wholesalers PDMA generally prohibits reimportation of Rx drugs

Answer 75

PDMA generally prohibits reimportation of Rx drugs Many stakeholders wish to obtain Rx drugs from Canada and other countries because of lower costs. The FDA has instituted a “compassionate use policy.” The CSA also allows for limited personal importation. The MMA allows wholesale importation of Rx medications from Canada, provided the secretary of DHHS would approve. The Homeland Security Act permits limited personal importation from Canada. The FDA will enforce the no importation law against businesses (Rx Depot case).

Answer 76

can be done at any time during business hours Can be required even whiteout probable cause if the inspector has an AIW The FDA can inspect a pharmacy to determine if the pharmacy is compounding or manufacturing. It can extend the search if probable cause exists that the pharmacy is manufacturing. The FDA may search without a warrant.

Answer 77

Tax Free- can be used in hospital Tax paid- can be found in the pharmacy Can use both in the pharmacy Tax-paid alcohol - Used in compounding in community pharmacies - Obtainable from outlets that sell liquor at retail Tax-free alcohol (190 proof ethyl alcohol) - Available to hospitals for medicinal, mechanical, and scientific purposes and in the treatment of patients. May be used only for inpatients. - Charity clinics may use medicines for outpatients if they do not charge.

Answer 78

used to prevent accidental child poisoning of a household drug Household Substances- Exceptions: - Drug requires it - patient requests it - MD requests it - Institutionalized patients - OTC-labeled requires it - Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate - For manufacturer: may market one size in a noncompliant package with the appropriate statement Intent of act to protect children from accidental poisonings due to “household substances” Administered by the Consumer Product Safety Commission The law establishes the standards for child-resistant containers. Container may not be reused unless glass or threaded plastic and then only with new closure.

Answer 79

- done to promote drugs on the market Price advertising - Considered reminder advertising and thus exempt from Section 502(n), provided that certain conditions are met Product advertising - Subject to strict liability standard

Answer 80

described the CS regulatory system of the U.S Highly regulated and kept on tight security in the U.S

Answer 81

used to organize drugs of abuse by their potential to be abused I-V I has no medical reason to be used Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence

Answer 82

I- LSD, Ecstasy, heroin, methaqualone, unapproved GHB II- Hydrocodone, cocaine, amphetamine, methamphetamine, amobarbital, glutethimide, secobarbital, and pentobarbital III- anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA IV- dextropropoxyphene; alprazolam, chloral hydrate, barbital, benzodiazepines; diethylpropion, phentermine; tramadol V- Includes antitussives containing codeine and antidiarrheals, lyrica

Answer 83

attorney general must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS

Answer 84

Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule. The symbol must be prominently located. - both need to include the schedule of abuse sticker and what schedule it is Adequate directions Dose and dosage form

Answer 85

Who needs to be registered all of these people need to be registered except - Manufacturer - Distributor - Dispenser - Conducting research Prescriber- no they do not What about the ultimate user- no they do not Anyone who manufactures, distributes, or dispenses controlled substances (among others) must register with the DEA. Manufacturers and distributors must register annually; dispensers must register every 3 years. Exemptions from registration include agents or employees of registrants, common carriers, ultimate users, prescribers, and dispensers in the service of the U.S. government, and law enforcement officers.

Answer 86

for distributors that are handling CSs Each principal place of business where CSs are administered, dispensed, or stored requires separate registration.

Answer 87

224- use this to register as a distributor/ as a pharmacy May not engage in activity where registration is required until registration is granted and certificate of registration issued Current registrants should receive a registration form approximately 65 days before expiration. A second notice will be sent electronically if required. The dispenser registration form is DEA Form 224, which is available online.

Answer 88

if a person ceases legal existence (whether by death or retirement) they need to contact the DEA and they will terminate the person’s name in the system Transfer: *Any modifications must be approved by the DEA. *If registrant dies or ceases legal existence, the DEA must be notified, and the registration terminated. *Registrations cannot be assigned or terminated without DEA approval. *If the registrant wishes to transfer business, a proposal must be submitted to the DEA at least 14 days prior to the transfer with required information.

Answer 89

Safe/Vault Alarm all of these need to be implemented so that a CS is kept safe away from the public Intersperse the CS through the other meds or keep it in a locked vault so that a robber cannot do a clean sweep All applicants and registrants must provide effective controls and procedures to guard against theft and diversion. The DEA considers several factors when evaluating the overall security system of a registrant or applicant. Individual practitioners must securely lock CSs in a substantially constructed cabinet. Pharmacies and institutional practitioners may do the same or disperse them throughout the stock of noncontrolled substances. May not employ any person whose application for registration has been denied or revoked

Answer 90

Negligent record keeping - prescribers and practitioners will be fined for the penalty of not. complying to record-keeping mandates Section 841 establishes penalties for drug traffickers and applies to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice. Section 842 establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping. The standard was changed from strict liability to negligence. Form 222 violations are subject to fines of up to tens of thousands of dollars and up to four years in prison. Knowingly or intentionally possessing a CS other than by a valid Rx could result in up to one year in prison and a fine of up to $1,000. The purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of CSs, or a person suffers “significant” injury or interstate commerce is involved in the planning or execution of the crime. Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.

Answer 91

4th amendment protects against being searched or no good reason No deny an inspection so far as they only have a search warrant but if they have an AIW, you cannot deny it, especially during business hours Constitutional issues - The Fourth Amendment protects individuals from unreasonable searches and seizures. - Requires the issuance of a search warrant based on probable cause - The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.

Answer 92

can be denied by a pharmacy if the PIC wants to Consent required

Answer 93

Valid Public Interest cannot deny inspection of someone with this Against probable cause In the interest of the public

Answer 94

DATA- can do narcotic treatment programs through office and use Subutex/suboxone Methadone- can be used as a treatment for this Subutex/Suboxone DEA Numbers- needed for someone to do an OTP, Qualified Physician- can do OTP What about mid level practitioners- yes they can do it too

Answer 95

protects ultimate users that have a CS - if they lose more than $500 of CS and or significantly hurt, then charges pressed against the person who committed the crime

Answer 96

imposes criminal liability on any person who knowingly or intentionally imports or exports a listed chemical, or reasonably believes that a listed chemical will be used to produce illegal drugs.

Answer 97

cannot be given for any athletic performance at all Example: testosterone

Answer 98

Daily: can only get 3.6g of pseudoephedrine a day Monthly- 9 g a month, 7.5 g a month for mail orders. 3.6 g = 3600 mg, 3600mg/30 days = 120 tablets a month Record-Keeping Requirements- need to keep record of Self Certification- need to provide ID so that you can the drug

Answer 99

can be done otherwise there would be no mail order! the mail package needs to be within compliance of US postal laws Must be sealed and individually labeled cannot reveal that there are drugs inside

Answer 100

given for legitimate medical reason Prescriber has valid DEA #

Answer 101

(of a medical practitioner) advise and authorize the use of (a medicine or treatment) for someone, especially in writing.

Answer 102

specific to prescriber IPs can start with A but now B or F Mid level start with M — PAs, NPs and also pharmacists if they can

Answer 103

for valid reason

Answer 104

can be done by an RPh as long as they do not change anything about patient, prescriber or the medication except if it is a change from brand to generic

Answer 105

- for legitimate medical reason

Answer 106

- on the RPh and prescriber that the Rx is for the right reason and written according to the FDA policy

Answer 107

can give CS for pain Pain is a legitimate medical reason that a CS can be given

Answer 108

Oral- can be given that way under emergency situations Written- can be given that way Fax- can be given that way Emergency

Answer 109

need the CS for immediate treatment No other medication option even amongst other CS Cannot give written Rx prior to dispensing

Answer 110

give the exact amount of the medication for treatment, no more or less Rx complies with the law except without a signature Made a good-faith effort tp verify the Rx

Answer 111

cannot be done without valid Rx established by the D-H amendment no refills for CII but refills for Schedule III and IV controlled substances cannot be filled or refilled more than 5 times or more than 6 months after the date the prescription, V & VI rules are silent In regard to a controlled substance in Schedule II or III, no prescription shall be filled for more than a thirty–day supply of such substance upon any single filling; provided, however, that with regard to dextro amphetamine sulphate and methyl phenidate hydrochloride, a prescription may be filled for up to 60 provided further, that subject to regulations of the department and the board of pharmacy, prescriptions for implantable infusion pumps consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days.

Answer 112

Retail- can be done within 30 days of the original Rx LTC- can be done within 60 days of the Rx Can be done within emergencies

Answer 113

if not over 18, do not provide valid ID, gives false Rx

Answer 114

needs to be written on separate sheets of papers, directions on the Rx, not in different color ink

Answer 115

III and IV - can be refilled: Refills 5 6 months V do not apply to 5 monthly refills and 6 month expiration Oral - can be given Fax - can be given Written - can be given

Answer 116

Partial fill- does it not match the regular guidelines below? II, III, IV, V- put these stickers as part of the label to indicate the schedule Pharmacy name and address Serial Number Name of patient Name of drug Directions for use and cautions Aux Sticker II, III, and IV NOT V

Answer 117

Can be done

Answer 118

Process in Process out

Answer 119

one pharmacy processes, and one fills They are both under contract agreement to have this relationship

Answer 120

can be done for any drug Under the Ryan Haight act, needs to be for a legitimate reason

Answer 121

every state has one Purpose is to monitor the distribution of drugs through the U.S for state to determine possible diversions

Answer 122

Time Inventory requirements - Initial- of RPh - Biennial- every 2 years - Exact count II and bottles greater than 1000 Best practice exact count of all Non-RX V- 279 Only by RPh Book Distribution - 5% RULE - If a distribute gives more than 5% of the total CSs dispensed throughout the year, then they will have to register as a pharmacy 222: Dispense 224: register as a pharmacy 41: dispose 106: report theft or loss

Answer 123

41- use to dispose and or destroy a CII 106- use to report loss or theft of CII within 1 day of discovering this situation 222- used to dispense and distribute CII 224 - application for registration

Answer 124

222- use to dispense and distribute CII Copy 1 Copy 2 Copy 3 Partial fill 222 CSOS- can be used instead of 222 Lost Stolen

Answer 125

someone other than registrant to sign a 222

Answer 126

Add together the first, third, and fifth digits. Add together the second, fourth, and sixth digits. Multiply the sum by 2. Add together the totals from Step 1 and Step 2. Verify that the last digit of the result of Step 3 matches the check digit of the DEA number.

Law exam 1 Flashcards

(156 cards)