Utah Pharmacy Mpje Law

Front 1

All records of controlled substances must be maintained for how long?

Back 1

2 years (federal)

5 years (state)

Front 2

To obtain a DEA registration, which form must be submitted?

Back 2

DEA Form-224

Front 3

What form must a pharmacy complete to report a theft or loss of controlled substances?

Back 3

DEA Form-106

Front 4

Controlled substance inventories should be maintained and readily retrievable for at least how long?

Back 4

1) 2 years (federal)
2) 5 years (utah)

Front 5

What form must a pharmacy complete in order to destroy controlled substances?

Back 5

DEA Form-41

Front 6

1)What is the daily sales limit of ephedrine, pseudoephedrine, or phenylpropanolamine for each purchaser?
2) No more than __ grams of these products can be purchased by a single person during a 30 day period

Back 6

1) 3.6 grams
2) 9 grams

(Federal limit)

Front 7

Records involving the transfer or destruction of controlled substances must be kept readily available for how long?

Back 7

2 years (federal)

5 years (state)

Front 8

How many times may a C-III or IV prescription be refilled?

Back 8

Up to 5 times within six months after the date of issue

Front 9

For an inventory of C-III, IV, and V substances, when is an actual physical count necessary?

Back 9

When a container contains more than 1,000 dosage units
(Federal)

Front 10

What concentration of a codeine preparation would be considered a C-V substance?

Back 10

No more than 200 mg/100 ml or 100gm

(Federal)

Front 11

"CAUTION: Federal law prohibits the transfer of this drug to any person..." must be printed the labels of which controlled substances?

Back 11

C-II, III, & IV

(Federal)

Front 12

To obtain a DEA Chemical Distributer registration, which form should be submitted?

Back 12

DEA Form-510

Front 13

When may a faxed C-II prescription be considered a "written prescription"?

Back 13

1) Patient is undergoing home infusion/IV pain therapy
2) Patient is in a long term care facility
3) Patient is in hospice care

Front 14

"The total number of dosage units of controlled substances distributed by a pharmacy may not exceed __% of all controlled substances dispensed by the pharmacy during a calendar year."

Back 14

5%

(Federal)

Front 15

What are the 4 basic elements of negligence?

Back 15

1) Duty - a legal obligation to conform to a specific standard of conduct for protection of another individual against an unreasonable risk of injury

2) Breach - a violation of that legal obligation by the defendant

3) Causation - the breach is the actual and promiate cause of the plantifs injury

4) Damage

Front 16

What law required safety testing for medications

Back 16

Food Drug and Cosmetic Act (1938)

Prompted by elixir of sulfanilamade

required "warning, may be habit forming" on narcotics and hypnotics

Front 17

What law legalized oral prescriptions and refills

Back 17

Durham-Humphrey Amendment to the FDCA (1951)

Front 18

What law required drugs to be tested for efficacy?

Back 18

Kefauver-Harris Amendment (1962)

Manufactures now required to provide safety and efficacy.

Also allowed for inspection of manufacturing facilities (GMP).

Established advertising procedures (prescription FDA), OTC (FTC))

DESI group

Front 19

What law created the Drug Enforcement Agency

Back 19

Controlled Substance Act (1970)

Scheduling of drugs and other substances

Front 20

What law required that all prescriptions be subject to special packaging requirements?

Back 20

Poison Prevention Packaging Act (1970)

Front 21

Can a physician make a blanket request to not place a patients prescription in a child-resistant container?

Back 21

No

Front 22

Can a patient make a blanket request to not place their medication in a child-resistant container?

Back 22

Yes

Front 23

Whats a class I medical device?

Back 23

Relatively low potential for causing harm - premarket testing is not necessary

e.g., scissors, forceps, hemostats, needles

Front 24

What is a class II medical device?

Back 24

Safety and efficacy must be evaluated by specific standards.

e.g., hearing aids, sunlamps, tampons, thermometers

Front 25

What is a class III medical device?

Back 25

Devices that are usually life-supporting systems.

e.g., indwelling catheters, neuromuscular stimulators, pacemakers

Front 26

What law essentially deregulated the herbal remedies industry

Back 26

Drug Supplement and Health Education Act (DSHEA) - 1984

Cannot claim they diagnose, cure, mitigate, treat or prevent diseases

Front 27

What does the Food and Drug Administration Modernization Act do?

Back 27

"Rx only" replaces warning

improve efficiency

incentive for pediatric clin studies

pharm cmpnding regulations

Front 28

What is considered biequivalence?

Back 28

within 80-125% of the reference drugs Cmax and AUC.

Same pharmaceutical agent, and the same dosage form

Front 29

Adulterated vs. Misbranded

Which one is primarily concerned with the physical condition of the drug or device and the enviornment of their manufacture

Back 29

Adulterated

Prohibited in interstate commerce

Front 30

Adulterated vs. Misbranded

Which one is primarily concerned with the representations made by the manufacturer concerning the drug or device

Back 30

Misbranded

Front 31

Aldulterated vs. Misbranded

A drug does not bear generic generic name in type not less than 1/2 the size of the trade or brand name

Back 31

Misbranded

Front 32

Adulterated vs. Misbranded

Which one does label and labeling discrepencies fall under

Back 32

Misbranded

Front 33

Aldulterated vs. Misbranded

Which one does a drug that does not conform to an official compendium fall under?

Back 33

Adulterated

Front 34

Adulterated vs. Misbranded

Insulin or antibiotic drug which is not batch certified

Back 34

Misbranded

Front 35

Who has the authority to schedule a drug?

Back 35

Attorney General

Front 36

What massive law included an indirect approach by the federal government to regulate the pharmacy profession and health care industry?

What are the 3 main components?

Back 36

Omnibus Budget Reconciliation Act (1990) - OBRA 90

1) Rebate programs
2) Demonstration projects
3) DUR programs

Intent was to promote cost savings and better fiscal management in government sponsored health care

Front 37

Which law protected health information?

Who is in charge of enforcing this law?

Back 37

Health Insurance Portability Accountabilit Act (HIPPA)

Department of Justice - Office of Civil Rights

Front 38

What law prohibits knowingly making false statements of a material fact in any application for a benefit or payment?

Back 38

Medicare/Medicaid Fraud and Abuse Act

Front 39

Who is in charge of enforcing the Medicare and Medicaid Fraud and Abuse Statute preventing kickbacks and refund checks on medicaid patients?

Back 39

Attorney General's office and Medicaid Fraud Control Units (MFCUs)

May punish pharmacy and/or pharmacist

Front 40

True or False

Manufacturers of controlled substances must label commercial containers of their products with a symbol identifying the classification?

Back 40

True

Typically C-I, C-II, C-III, C-IV, or C-V

Front 41

Narcotic schedule III agents may not contain more than:

Back 41

1) 1.8 grams of codeine or dihydrocodeine per 100 ml or not more than 90 mg per dosage unit
2) 300 mg of dihydrocodeine or ethylmorphine per 100 ml or 15 mg per dosage unit
3) 500 mg of opium per 100 ml or not more than 25 mg per dosage unit
4) 50 mg of morphine per 100 ml

Front 42

Do pharmacists need a registration to manufacture or distribute any controlled substance or list 1 chemical?

Back 42

No, we dispense, not manufacture or distribute.

Front 43

Do pharmacists need to register with the DEA via a 224 form in order to dispense controlled substances?

Back 43

No - the pharmacy must be registered and we are exempted from this because we are an employee acting in the usual course of our employment

Front 44

How often must pharmacy registrations be renewed with the DEA?

When should the pharmacy expect to receive a renewal application?

Back 44

Every 3 years

45 days prior to the registration expiring

Front 45

Does each place of business have to be registered with the DEA?

Back 45

Yes

Front 46

What must a pharmacy do to change an address?

Back 46

A new DEA certificate reflecting the new address must be obtained. A request for modification of the registration should be sent to the DEA before the effective date of the move.

Front 47

What form is required for a renewal of a DEA registration?

Back 47

224a

Front 48

Corporations that own or operate a chain of pharmacies may submit a single _________ Form that does what?

Back 48

a DEA Form-224b

This is an affadavit for renewal of retail/chain pharmacy registration.

Front 49

Who has the right to suspend or revoke a DEA registration?

Back 49

The Attorney General

Front 50

What 4 things must be done if terminating a registration?

Back 50

1) Any registrant who discontinues his/her business or transfers it to another person must notify the nearest DEA registration field office IN WRITING before terminating the pharmacy's registration
2) Send the DEA the certificate of registration and any unused 222 forms
3) Write or stamp VOID across the face of each order form. The DEA should also be notified of where and how the C.S. were transferred and where the records will be stored
4) Records involving C.S. must be kept available for 2 years (federal)

Front 51

What 2 things must be done if transferring a business

Back 51

1) Notify the DEA field office at least 14 days before the date of the proposed transfer
2) On the day of the C.S. transfer, a complete controlled substance inventory must be taken and a copy of the inventory must be included in the records of BOTH the person transferring the business and the person acquiring the business

Front 52

What are the 2 ways to dispose of controlled substances?

Back 52

1) Transfer controlled substances to another pharmacy via a DEA Form-222 (C-I and C-II only). Document the transfer of C-III through V in writing.

2) Destruction of controlled substances (Form 41)

Front 53

Who may a pharmacy transfer controlled substances to?

Back 53

1) To another pharmacy
2) To another supplier or manufacturer
3) To a reverse distributor (DEA Form-222 needed from distributor)

Front 54

How may a pharmacy destroy controlled substances?

Back 54

First contact the nearest DEA Field Office
1) Once-a-year DEA Authorization for Destruction - DEA Form-41
2) Obtain an authorized member of a state law enforcement authority or regulatory agency to witness the destruction (Send in a DEA Form-41 after)
3) Reverse Distributor
4) "Blanket Authorization" for destruction - hospitals

Front 55

What must be done in order for a reverse distributor to destroy controlled substances from your pharmacy?

Back 55

They must issue a DEA Form-222 to the pharmacy for C-IIs, then they will fill out a DEA Form-41 after the drugs have been destroyed.

Front 56

What must be done for the Once-a-year DEA authorization for destruction of controlled substances?

Back 56

1)A DEA Form-41 must be filled out listing all drugs that will be destroyed.
2) Pharmacy must prepare a letter outlining the drugs, date, and method of destruction, along with the names of at least 2 MLP who will witness the destruction.
3) After destruction, the pharmacy needs to send in the signed DEA Form-41 into the DEA

Front 57

What are the 2 options for keeping controlled substances in a pharmacy?

Back 57

1) in a locked cabinet
2) Dispersed throughout the pharmacy along with the non-controlled substances

State law requires an alarm system - not federal.

Front 58

Can an employee with a felony relating to a controlled substance be hired as a pharmacist?

Back 58

Yes (Federal) - the pharmacy must request the DEA for an employment waiver.

Sorta (State) - DOPL has option to grant individual a pharmacists licence and NOT a CS licence.

Front 59

What must be done if controlled substances are found to be missing or stolen?

Back 59

1) Contact the nearest DEA Field Office
2) Notify the local police
3) Complete a DEA Form-106 listing the name, address, DEA number, date of theft, name and # of local police, type of theft, listing of C.S. missing

Front 60

When may the federal government investigate thefts or robberies.

Back 60

1) above $500
2) someone is killed or suffers significant bodily damage
3) interstate or foreign commerce is involved

Front 61

What are the 3 options for precription record keeping?

Back 61

1) A file for C-II, C-III-V, non controlled
2) A file for C-II, and a file for all others with C-III through V having a red C stamp.
3) A file for C-II through V (schedule III - V must have a red C stamp), then a non-control file.

(Utah does NOT allow for #3)

Front 62

How often must a pharmacy take a controlled substance inventory (federal)?

Back 62

Biennial inventory (every 2 years)

no need to submit to DEA

An actual physical count of all C-IIs has to be done. C-III through V can be estimated unless the container holds > 1000 pills

Front 63

What form is used to order more 222 forms?

Back 63

222a form

Front 64

How many order forms does each 222 form contain?

Back 64

Each book contains seven sets of forms. Each pharmacy may have up to 6 books. Max of 42 forms in the pharmacy

Front 65

What must a pharmacist do to complete a 222 order form?

Back 65

fill in the # of packages, the size of the package, and the name of the item. When the items are recieved, the RPh must document on the purchaser's copy (copy 3) the actual # of packages received and the date received.

Front 66

Power of Attorney to Sign an Official Order Form

Back 66

Any registered pharmacy may authorize one or more individuals (do not have to be Rphs) to obtain and execute the forms.

The POA must be signed by the same person who signed the most recent application for registration.

Front 67

What must be done upon discovering the loss or theft of unused order forms?

Back 67

You must immediately report the loss to the nearest DEA diversion field office and report the serial numbers.

Front 68

According to federal law, how long does a patient have to fill a C-II?

Back 68

Indefinitely (some interpret as 1 year). The RPh must determine that the prescription is still needed by the patient.

(This is obviously different in Utah)

Front 69

Emergency C-II prescriptions

Back 69

1) May only fill for 72 hours
2) Immediately reduced to writing by the pharmacist
3) Pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner.
3) Within 7 days the M.D. must furnish the pharmacist a written, signed prescription. The prescription must have written on its face "Authorization for Emergency Dispensing". The pharmacist must notify the nearest DEA office if this does not happen, if the RPh fails to do this he/she will not longer be able to dispense without a written Rx.

Front 70

Can a pharmacy provide a partial fill for a C-II prescription?

Back 70

Yes - if the pharmacy is unable to fill the entire quantity. The RPh must write the quantity supplies on the front of the prescription.

The remaining quantity may be dispensed within 72 hours of the first partial dispensing.

Front 71

What are the 4 elements necessary for a doctor/patient relationship?

Back 71

1) A patient has a medical compaint
2) A medical history has been taken
3) A physical exam has been performed
4) Some logical connection exists between the medical compaint, medical history, physical exam, and the drug prescribed

Front 72

Narcotic treatment program registered with DEA can only handle the narcotic substances applied for on what form?

Back 72

DEA Form-363

Front 73

Can you mail a controlled substance?

Back 73

Yes - has to meet U.S. Postal Service Mailing Requirements for Controlled Substances.

Cannot be superficially identified. Inner contents are labeled to show the name and address of pharmacy.

CANNOT GO OUT OF CONTRY

Front 74

When does the logbook for the combat methamephetamine epidemic act not apply?

Back 74

The logbook does not apply to any purchase by an individual of a single sales package that contains less than 60 mg of PSE.

The logbook requires photo ID

Front 75

How many members are on the board of pharmacy?

Back 75

Seven

5 pharmacists, one technician, and one lay person.

R.Phs and tech need to have practiced continuously for at least three years in the state, and at least 5 years overall.

Front 76

How long does a license last before it expires?

Back 76

2 years

September 30 on odd years

Front 77

How long must you maintain your CE information?

Back 77

4 years after your licensed has been renewed.

Front 78

What is the shortest duration for which a license may be suspended?

Back 78

A minimum period of 90 days

Front 79

Diversion committees consist of how many professionals within the same or similar occupation?

Back 79

At least 3

Front 80

How many times may a licensee be eligible for the diversion program?

Back 80

Only once for the same or similar offense.

Front 81

Whats the maximum term of a diversion agreement?

Back 81

Maximum of 5 years

Front 82

Does a diversion offense remain on a pharmacist's record if he/she successfully completes the diversion program as stipulated by the board?

Back 82

No - its as if it had never happened

Front 83

Can DOPL inspect a pharmacy whenever they want?

Back 83

Nope - it has to be within regular business hours and they must present ID, describe the nature of the visit, provide upon request the authority of the division to conduct the search, and then they may view the license(s)

Front 84

What is a class A pharmacy?

Does it require a pharmacist-in-charge?

Back 84

A retail pharmacy

Yes - must have a PIC

Front 85

How many hours must a pharmacist who is applying for licensure by endorsement have?

Back 85

A minimum of 2000 hours in 4 years immediately preceeding application in Utah.

Front 86

How many hours of supervised practice must a pharmacist applicant have to be eligible for licensure?

Back 86

1500 total hours

Front 87

How many hours in each setting are required by DOPL for an applicant to be considered for a Pharmacist licence.

Back 87

120 in community pharmacy
120 in institutional pharmacy and
120 in any clinical setting

Front 88

What is required to be a preceptor?

Back 88

An active license
1 years of experience
Provide supervision to only 2 interns during a working shift

Front 89

How many hours of CE are required?

Back 89

30 total hours

Front 90

How many hours of live CE are required?

Back 90

12

Front 91

How many hours of CE are required for Drug therapy and patient management?

Back 91

15

Front 92

How many hours of CE are required to be on law or ethics?

Back 92

1

Front 93

Within what time frame must you contact DOPL when changing your address?

Back 93

10 days

Considered unprofessional conduct

Front 94

How many techs and interns can a pharmacist supervise at any given time?

Back 94

Unlimited technicians (pharmacists discretion) and 2 intern

Front 95

What 8 items must a label contain?

Back 95

1) pharmacy info (name, etc)
2) Rx #
3) fill date or last dispensing date
4) patient name
5) presciber
6) directions for use
7) medication info (name, strength, etc)
8) beyond use date

Front 96

Whats the minimum notice a pharmacy can give to DOPL before it closes?

Back 96

14 days

PIC must write a letter to DOPL within 10 days of closing

Front 97

State law dictates a CS inventory be taken how often?

Back 97

Annually

Front 98

Unprofessional vs. Unlawful conduct

Not offering counseling

Back 98

Unprofessional

Front 99

May a pharmacist refill a controlled susbtance prescription if the patient is out of refills?

If so, what must be done?

Back 99

Yes - other than C-II substanceas

A pharmacist may exercise his/her professional judgment to refill a prescription, provided:
1) Failure to refill might result in an interruption of a regimen or create patient suffering
2) RPh made a reasonable effort to contact the practitioner, this effort must be documented
3) Quantity does not exceed a 72 hour supply
4) inform the patient that this refill is being provided without authorization
5) Pharmacist informs the M.D.
6) Maintains a record of the emergency fill.

Front 100

What references must a pharmacy have readily available and retrievable to personnel?

Back 100

1) DOPL Act
2) General rules of DOPL
3) Pharmacy practice act
4) Utah Pharmacy Practice Act Rules
5) Utah Controlled Substance Act
6) Utah Controlled Substance Act Rules
7) USP DI Drug Reference Guides
8) Orange Book
9) any other reference needed to perform practice dictated by the usual course of business

(All of these can be bookmarked on a computer terminal)

Front 101

Can a physician write a controlled substance with a sig of UD?

Back 101

Nope - must be something like QID UD

Front 102

How many times may a CIII or C-IV be filled?

Back 102

May be filled only within 6 months of issuance, and may not be refilled more than 5 times.

Front 103

How long is a C-V good for?

Back 103

12 months

Front 104

When does a C-II expire?

Back 104

after 30 days

Front 105

True or False

Each Rx for a controlled substance may have other controlled substances on it, but not non-controlled substances?

Back 105

False

Each Rx for a CS may contain only 1 controlled substance and may not contain any other legend drugs.

Front 106

When an M.D. writes for three C-II prescriptions that are for the same medication, what must be included on the 2nd and 3rd Rx?

Back 106

The date of issuance and the date for dispensing.

Unless there is a valid medical reason, the date for dispensing may not be < 30 days from the dispensing date of the previous prescription.

Front 107

Can a M.D. prescribe a controlled substance for a minor without notifying the parental unit?

Back 107

No - unless it is an emergency

Front 108

Are M.D.'s allowed to write for a C-II or C-III for weight loss?

Back 108

No

Front 109

What must be done for a C-II emergency prescription?

Back 109

1) Cannot exceed 72 hours
2) M.D. has examined the patient w/i 30 days
3) A written prescription is delivered to the pharmacist within 7 days
4) A reasonable effort to ensure that the M.D. is licensed to prescribe a C.S.

Front 110

Which of the following may a support personnel not help with?

a) Stocking
b) Cashiering
c) Billing
d) Filing hardcopies
e) Counting and filling prescriptions

Back 110

e) Counting and filling prescriptions

Front 111

Unlawful vs. Unprofessional
Knowingly preventing or refusing to permit any authorized agent to conduct an inspection

Back 111

Unlawful

Front 112

Unlawful vs. Unprofessional

Failing to deliver the license, permit, etc to the division upon demand

Back 112

Unlawful

Front 113

Unlawful vs. Unprofessional

Conducting business under the name which contains “drugstore” , “apothecary”, “pharmacy”, etc. unless the place is a licensed pharmacy

Back 113

Unlawful

Front 114

Unlawful vs. Unprofessional

Buying, selling any drug which bears the name “sample”, “not for resale”, “for investigational use only

Back 114

Unlawful

Front 115

Unlawful vs. Unprofessional

Using to his own advantages or revealing to anyone other than the division or BOP, any information acquired under authority of this chapter or concerning any method of process which is a trade secret

Back 115

Unlawful

Front 116

Unlawful vs. Unprofessional

Requiring any employed pharmacist, intern, etc. to engage in conduct in violation of this chapter

Back 116

Unlawful

Front 117

Unlawful vs. Unprofessional

Being in possession of a Rx-only drug for any unlawful purpose

Back 117

Unlawful

Front 118

Unlawful vs. Unprofessional

Willfully deceiving the division, the board, or agents regarding compliance with this chapter

Back 118

Unprofessional

Front 119

Unlawful vs. Unprofessional

Paying rebates to practitioners or other providers

Back 119

Unprofessional

Front 120

Unlawful vs. Unprofessional

Misbranding or adulteration of any drug

Back 120

Unprofessional

Front 121

Unlawful vs. Unprofessional

Dispensing of any outdated, misbranded, or adultered drug

Back 121

Unprofessional

Front 122

Unlawful vs. Unprofessional

Engaging in the sale or purchase of drugs that are samples

Back 122

BOTH

Front 123

Unlawful vs. Unprofessional

Accepting back and redistributing of any unused drug after it has left the premises of the pharmacy unless the drug is in a unit pack or the manufacturer’s sealed container

Back 123

Unprofessional

Front 124

Unlawful vs. Unprofessional

Violating the Fed and Utah CSA

Back 124

Unprofessional - probably both?

Front 125

Unlawful vs. Unprofessional

Disclosing confidential patient information in violation of HIPAA

Back 125

Unprofessional

Front 126

Unlawful vs. Unprofessional

Engaging in practice of pharmacy without a licensed pharmacist designated as pharmacist in charge

Back 126

Unprofessional

Front 127

Unlawful vs. Unprofessional

Preparing as a pharmacist or intern, a prescription drug for sale to another pharmacist or pharmacy

Back 127

Unprofessional

Front 128

Unlawful vs. Unprofessional

Obtaining a passing score on licensing exam or application by fraud, forgery, or deception or omission

Back 128

Unlawful

Front 129

Unlawful vs. Unprofessional

Practicing through gross imcompetence, and gross negligence

Back 129

Unprofessional

Front 130

Unlawful vs. Unprofessional

Violating any statue, rule or order regulating the pharmacy profession

Back 130

Unprofessional

Front 131

A pharmacist may accept back and redistribute any unused drug after it has left the pharmacy if:

Back 131

a. The drug was prescribed to a patient in an nursing care facility, LTCF, state prison, county jail, or state hospital
b. The drug was stored under the supervision of a licensed health care provider according to the manufacturer recommendations
c. The drug is in a unit pack or manufacturer’s sealed container
d. The drug was returned to the original dispensing pharmacy
e. The drug was initially dispensed by a licensed pharmacist or intern
f. Accepting back and redistribution of the drug complies with the FDC Act and CSA

Front 132

Whats the punishment for unlawful practice?

Back 132

Class A Misdemeanor

Front 133

Unlawful vs. Unprofessional

Failing to provide DOPL with a current mailing address within 10 business days following the change of address

Back 133

Unprofessional

Front 134

Unlawful vs. Unprofessional

Practicing pharmacy with the inappropriate pharmacist to intern ratio

Back 134

Unprofessional

Front 135

FDA Recall

Class I

Back 135

Worst case

serious ADR

death

Front 136

FDA Recall

Class II

Back 136

Medium

temporary or reverisble damage

remote chance of ADR

Front 137

FDA REcall

Class III

Back 137

Low

not likely ADR

Front 138

Food and Drug Cosmetic Act (1906)

Back 138

SAFETY

Narc "may be habit forming"

expand definition of misbrand/adulteration

Front 139

Durham-Humphrey (1951)

Back 139

ORAL ORDER

allowed doctor dispensing for administration

"caution: federal law prohibits dispensing without a prescription"

Front 140

Kefauver-Harris (1962)

Back 140

EFFICACY

standards for GMP (good mfg practices)

advertising - FDA:RX FTC:OTC

new drug approval process

Front 141

Control Substance Act (1970)

Back 141

created DEA

scheduleing of drugs

resigrations

Front 142

Poison Prevention Packaging Act (1970)

Back 142

child-resistant

no more than 20% of kids <5 yo can open in <10 min

Front 143

Harrison Narcotic Act (1914)

Back 143

Manufacturing and distributing limits on opium

Front 144

Medical Device Act (1976)

Back 144

Brought devices under the perview of the FDA

Front 145

Orphan Drug Act (1983)

Back 145

Provided special incentive for drug manufactures to create treatments for rare diseases

Front 146

Drug Price Competition and Patent Term Restoration Act (1984)

(aka Hatch/Waxman)

Back 146

Created the ANDA, allowing for cheaper/quicker releases of generic drugs

Front 147

Prescription Drug user Fee Act (1992)

(aka PDUFA)

Back 147

Required higher fees for drug manufactures when getting drugs approved

Sped up the NDA approval process

Front 148

Dietary Supplements & Health Education Act (1994)

(DSHEA)

Back 148

Dietary Supps and Herbal crap cannot claim to "diagnose, cure, mitigate, treat, or prevent disease"

Front 149

Food and Drug Modernization Act (1997)

Back 149

"Rx only" replaces warning

improve efficiency

incentive for pediatric clin studies

pharm cmpnding regulations

Front 150

Class A Pharmacy

Back 150

Retail

Front 151

Class B Pharmacy

Back 151

Institutional

hospital, clinic, closed door, nuclear, branch, pharm admin, sterile product

Front 152

Class C Pharmacy

Back 152

mfg, productions, wholesale, distribution of drugs and devices

Front 153

Class D Pharmacy

Back 153

non- residential (mail order)

Front 154

Class E Pharmacy

Back 154

"Other" classification of pharmacies

(animal euthanasia, research facilities)

Front 155

DEA Form 41

Back 155

DESTRUCTION

notify DEA and send copy

keep records 5 years

Front 156

DEA Form 224

Back 156

New Pharmacy Registration

Front 157

DEA Form 224a

How often?

Back 157

Renewal pharmacy registration

Every 3 year

Receive renewal form 45 day prior to exp

Front 158

DEA Form 510

Back 158

DEA Chemical Distributor Registration

Front 159

DEA Form 224b

Back 159

Renewal chain pharmacies

Front 160

DEA Form 222

Back 160

Ordering or Transfering CII

Copy 1 is retained by the DISTRIBUTOR
Copy 2 is sent to the FDA
Copy 3 is retained by the PURCHASER

Front 161

DEA Form 222a

Back 161

Ordering more 222 forms

limit of 6 books with 7 forms each (42 MAX)

Front 162

DEA Form 106

Back 162

report theft or loss of CS

notify DEA w/in 1 day of discovery

notify DOPL (send copy)

includes shipping losses

notify local police and get case #

Front 163

DEA Form 363

Back 163

narcotic treatment program

Front 164

Inventory Requirement (Federal)

CII?

CIII-V?

Back 164

CII: actual count

CIII-V: estimate okay unless container is >1000 units and has been opened

Front 165

Inventory Requirement (State)

Back 165

1. Annually
2. Kept for 5 years
3. CI & CII records kept separate from CIII - V

Front 166

Prescription Transfers

Who to who?

Keep record how long?

Back 166

Pharmacist to pharmacist (or intern)

5 years keep records

Must void rx and write "void" on original

Front 167

How to record a transfered Rx (5 reqs)

Back 167

1. Date of issue, first and last fill
2. Original rx #
3. Original refills and amt remaining
4. Name, address of sending pharmacy
5. Name of both pharmacists/interns

Front 168

Additional Reqs for E-Scripts (4 reqs)

Back 168

1. time and date transmitted
2. name of intended pharmacy
3. deemed original rx
4. record kept for 5 years

*e-script presented physically by pt can NOT be filled*

Front 169

Prescription requirements

Back 169

Doctor Info (Name, address, phone, DEA if controlled)
Patient Info (Name, address, DOB if controlled)
Date of issuance
Drug Info (Name, quantity, directions)
Doc Signature

Front 170

Label requirements

Back 170

Pharmacy Info (Name, address, phone)
Rx Number
Date filled/dispensed
PT name
Doc name
Drug info (Name, strength, quantity)
Directions (and caution statements if necessary)
Expiration date (Federal LAW!!!)

Front 171

Generic Sub allowed if

Back 171

1. PT requests or consents
2. A/B rated in orange book
3. Pharmacist/intern counsels pt on use and expected response
4. Not DAW rx

Front 172

Drug samples okay to dispense by doc if...

Back 172

1. not CII, benzo, opioid
2. in original mfg container
3. marked as sample on container OR marked in pt chart sample was given (name and quantity)
4. 30 day sup limit on controls
5. free of charge to pt

Front 173

Patient counseling by pharmacist should include

Back 173

1. Name and description of drug
2. form, ROA, dose, duration of therapy
3. indication and expected action
4. special directions
5. common, serious ADR
6. self-monitoring
7. storage
8. missed dose
9. expiration date/BUD

Front 174

Schedule I

Back 174

1. no medical use
2. can NOT be prescribed or dispensed
3. for research/lab/analysis only

heroin, marijuana, mathaqualone, LSD, etc

Front 175

Schedule II

Back 175

1. medical use
2. high abuse potential
3. severe pysch or physical dependence

cocaine, fentanyl, secobarbital, hydrocodone, poppy, coca leaves, amobarbital, pentobarbital, phencyclidine, oxycodone, others

Front 176

Schedule III

Back 176

1. medical use
2. less abuse potential than CII
3. high psych, moderate-low physical dependence

anabolic steroids, ketamine, hydrocodone combos, dronabinaol, amobarbital, benzphetamine, chlorphentermine, buprenorphine,

<1.8 g codeine/100ml (or 90mg per unit)

<1.8 g dihydroco/100ml (or 90mg per unit)

<300 mg dyhydro/100ml (or 15mg per unit)

<300 mg ethylmorphine/100ml (or 15 mg/unit)

Front 177

Schedule IV

Back 177

1. Medical use
2. less abuse potential than CIII
3. limited psych or physical dependence

soma (carisoprodol), lunesta (eszopiclone), sonata (zaleplon), benzo's, nuvigil, provigil (modafinil), fenfluamine, phenteramine, sibutramine

Front 178

Schedule V

Back 178

1. medical use
2. low abuse
3. limited psych or physical dependence

lomotil, phenergan with codeine, pyrovalerone

<200mg codeine/100ml or g
(Cheratussin, Pediacof)

<100mg hydrocodone/100ml or g
(Cophene-s)

<100mg ethylmorphine/100ml or g

<2.5 mg diphenoxylate and 25mg atropine per unit
(lomotil)

Front 179

DEA Number Check

Back 179

two letters and 7 #'s

first letter ID's registrant

- A,B,F: hospital, clinic, practitioner, pharmacy, teaching institution

- M: midlevel practioner (PA, NP, OD, APN, CNP,

- P, R: mfg, distrib, research, analytical, importer/exporter

-X: DATA doc

AB1111119

1st + 3rd + 5th = 3

2nd + 4th+ 6th = 3 x 2 = 6

3+6 = 9 (last number of DEA)

Front 180

CII Requirements (Utah)

Back 180

1. no refills
2. 30 day sup
3. exp 30 days from date written
4. can NOT be filled after 30 days from last dispense date if separately indicated from issue date
5. may not contain another rx

Front 181

CII Multiple RX requirements (Utah)

Back 181

1. limit 3 rx's
2. limit 30 days each
3. date of issue and date to be filled on 2nd and 3rd
4. can NOT dispense sooner than 30 days from date last filled

Front 182

CIII-IV rx requirements

Back 182

1. 6 month expiration from date of issue
2. only refill 5 times
3. can NOT contain another rx

Front 183

CV rx requirements

Back 183

1. rx in utah
2. 1 year expiration from date of issue
3. refills as doc directs
4. can NOT contain another rx

Front 184

True or False

Control rx must contain specific sig for use

Back 184

True

cannot just be UD

Front 185

Emergency verbal CII okay if...

Back 185

1. Limit 72 hour sup
2. cover to follow in 7 days
3. report to dea if no cover, or else pharmacist cannot accept oral CII orders
4. prescriber-pt relationship (seen w/in last 30 days)

Front 186

Partial CII okay if

Back 186

1. can NOT supply full quantity
2. must dispense remaining in 72 hours
3. pharmacist notes quantity given on front of rx
4. contact prescriber if can't supply in 72 hours - need new rx now

Front 187

Partial CIII-V okay if

Back 187

1. noted dispensed quantity and initials back of rx
2. may not exceed total amt auth on rx
3. may not be filled after 6 months from issue

Front 188

What can NOT be changed on a CII

Back 188

Any names or dates:

Any names (Drug name, PT name, Doc name/signature)
Any dates (date written, "to be filled" date)...PT's DOB is ok to change.

Front 189

CS Database

Pharmacist submits how often?

Back 189

Weekly

Electronically

Front 190

CS Database

Cover page should include

Back 190

1. Pharmacy name
2. NABP#
3. Period of time of submission
4. Date prepared
5. Date Submitted
6. Number of rx's
7. RPh signature

Front 191

CS Database

For each rx info submitted:

Back 191

1. Name of doctor, pharmacy, RPh
2. Date issued and filled
3. Name of patient
4. Their form of ID and ID number
5. Name of drug, strength, quantity, directions

Front 192

CS Database

Who has access?

Back 192

1. pharmacist (NOT intern)
2. doc (may designate 3 ppl)
3. mental health therapist
4. DOPL investicational staff
5. DOPL and health dept authorized to analyze CS rx's
6. ultimate user with DOPL approval

***3rd degree felony if access illegally***

Front 193

True or False

It is unlawful or unprofessional to prescribe or dispense for "the partner of ____".

Back 193

True and false.

It is ok to dispense for a partner if the medication is used to treat an STD.