Federal Law

Question 1

Pure Food, Drug, and Cosmetic Act of 1906

Answer 1

banned impurities (adulteration), AKA Wiley-Heyburn Act, can’t lie on label (misbrand)

Question 2

Harrison Narcotic Act

Answer 2

1914, first control of narcotics, required prescription or to be sold from a pharmacy

Question 3

Food, Drug and Cosmetic Act of 1938

Answer 3

Must prove SAFETY (not efficacy) in order to market a drug, in response to sulfanilimide disaster - charged with misbranding despite causing deaths, most drugs still over the counter

Question 4

Durham-Humphrey Amendment of 1951

Answer 4

prescription drugs differentiated from over the counter drugs, prescriptions to be dispensed if oral/written/refilled, required “Caution: Federal law prohibits dispensing without a prescription” which was changed to “Rx only”

Question 5

Kefauver-Harris Amendment of 1962

Answer 5

drug efficacy act, required drug to be proven both safe and effective if introduced after 1962, other drugs were grandfathered in as desi-drugs

Question 6

Requirements of Labels on Commercial Containers

Answer 6

1. Name + address of manu. 2. Ingredient info. 3. Generic + brand name. 4. Quantity (strength). 5. Net quantity of package (#pills). 7. Expiration date. 8. Lot #. 9. NDC# (optional, but necessary for billing)

Question 7

Requirements of Labels on Unit Doses

Answer 7

1. Name + address of manu. 2. Generic + brand name. 3. Expiration date. 4. Lot #.

Question 8

Package Inserts

Answer 8

dispense with antidepressants, hormones, accutane, etc. required to give on first fill and every refill. hospitals supposed to give with initial dose and q30d but not enforced.

Question 9

Repackaged drugs expiration

Answer 9

determined by package material. if manu exp is 2 yr + then 6 mo expiration. if manu exp is 1 yr then 3 mo exp. (6 mo or 25% from manu labeled date, whichever is shorter)

Question 10

Customized Med Packages (1+ drugs in unit dose blister)

Answer 10

not allowed unless consent of patient, caregiver, or provider (LTC). reduces med errors.

Question 11

Drug definition

Answer 11

article recognized by USP; article intended for use in dx. cure, mitigation, tx, or ppx of disease; article other than food intended to affect the structure/function of body

Question 12

Prescription Drug Marketing Act of 1987

Answer 12

Drug diversion act, reduces potential risk of diversion of rx drugs from legit commercial channels, re-importation is banned (ex. Mexico/Canada), if <90 supply - not enforced but still illegal, prohibits sale of non-emergency rx by hospitals to non-hospitals, bans sale of samples, requires prescriber (not staff) to request samples in writing, mandates storage and records of samples, prohibits sale of human drugs bought by charitable institutions at reduced prices

Question 13

misbranding definition

Answer 13

dispensing of a drug in violation of labeling requirements, selling an rx drug at retail without rx

Question 14

adulteration definition

Answer 14

drugs that contain filthy, putrid, and decomposed (started at 1 strength, now another) substance or drugs held in unsanitary conditions. AKA not with current good manu practice (cGMP), containing unsafe color additives

Question 15

OTC drug requirements

Answer 15

same labeling as rx, hospitals only allowed to use in-house, retail pharmacies only allowed to sell to customers

Question 16

Authority to prescribe

Answer 16

OB-GYN, ENT, psychiatrists not restricted by specialty. Limited by specialty: veterinarians, podiatrists, dentists, optometrists. Opthalmologists, chiropractors, and psychologists not authorized to prescribe in NC.

Question 17

Therapeutic substitution

Answer 17

drugs within same class allowed in retail and hopstial with protocols due to prior consent, pharmacist selects brand unless prescriber notates for the contrary

Question 18

Generic substitution

Answer 18

Orange book has AB ratings for generic equivalency info, in NC the pharmacist makes substitution based on knowledge (orange book optional)

Question 19

Refill authorization

Answer 19

any rx or refill communication can be by the prescriber, the agent of the prescriber, or another prescriber covering for the first prescriber (in the new prescribers’ name)

Question 20

Compounding law

Answer 20

governed by states, cannot compound any drug that has been withdrawn or removed from market because they are unsafe or not effective, may not distribute out of state more than 5% of total rx dispensed, sterile compounders encouraged to register with DEA and follow cGMP, compounding OTC products without rx is illegal via NC.

Question 21

Off label uses

Answer 21

prescriber allowed to prescribe drugs off label, ask prescriber for indication in order to counsel patient

Question 22

ipecac syrup

Answer 22

available OTC <30 ml or 1 fl oz bottles, requires labeled warning (keep out of reach of children, etc), used to cause vomiting in poisoning. fluid extract of ipecac is deadly poison and should not be stocked. dosing: 15 ml in pts 1+ YO.

Question 23

Poison Prevention Packaging Act of 1970

Answer 23

does not apply to topicals. child-proof bottles for all rx drugs except NG SL/etc for immediate use, dual purpose lids allowed when dispensed in childproof mode. patient or prescriber may request nonsafety containers, rph may only advise pts of the avail of nonsafety, pt may issue blanket request (no sig required), prescriber can only request nonsafety containers per pt and can be overridden.

Question 24

Childproof packaging

Answer 24

<20% children should not be able to open even after being shown how. <10% adults should be unable to gain access within specified time. childproof contained have limited effectiveness so reuse is prohibited due to wear and tear. glass vials are reusable but top must be replaced.

Question 25

poison sale laws

Answer 25

sales recorded in front of CV book, requires 1) date 2) name of poison 3) purpose of poison 4) sig + address of buyer

Question 26

federal anti-tampering act

Answer 26

reactive to tylenol poisoning, required anti-tamper packaging (foil seal, cotton ball, cellophane box)

Question 27

HIPAA

Answer 27

health insurance portability and accountability act, new patients get notice of privacy practice, obtain sig and list of persons to release info, document to who you release info. allowed to release info for treatment, operations (delivery), or payment. obtain agreements fro mdelivery, etc annually.

Question 28

Federal Drug Recall Class I

Answer 28

drug may cause serious ADRs including death. must notify pts you have dispensed the drug to them; mandatory return of inventory.

Question 29

Federal Drug Recall Class II

Answer 29

drug may cause temporary or reversible ADR. inventory should be returned, inform pt.

Question 30

Federal Drug Recall Class III

Answer 30

drug not likely to cause ADRs.

Question 31

drug labeling rules for preg/breastfeeding

Answer 31

now lactation (was nursing mothers), mentions amount of drug secreted in breast milk and potential effect on baby, new category of females and males of reproductive potential

Question 32

Healthcare Fraud, Waste, Abuse Training

Answer 32

required annually by Medicare Part D, allowed to complete online, documentation may be required, includes whistleblowing provisions (self-reporting)

Question 33

Tamper resistant Rx blanks

Answer 33

required by mediaid, does not apply to e-rxs/faxes/phone, must have 3 features to prevent: 1) copying (blue/green background, void pattern when faxed), 2) erasure/modification (thermochromic ink, check boxes like 1-24/etc) , 3) counterfeiting (watermark or logos)

Question 34

Drug Supply Chain Security Act

Answer 34

effective 2015, delayed to 2016, enhancement of reimportation law, must keep track of all who have had possession of all drugs, provided by wholesalers, pharmacy must retain invoices for 6 yrs, supersedes all state laws on drug pedigree