Federal Law Flashcards
Pure Food, Drug, and Cosmetic Act of 1906
banned impurities (adulteration), AKA Wiley-Heyburn Act, can’t lie on label (misbrand)
Harrison Narcotic Act
1914, first control of narcotics, required prescription or to be sold from a pharmacy
Food, Drug and Cosmetic Act of 1938
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
Durham-Humphrey Amendment of 1951
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”
Kefauver-Harris Amendment of 1962
drug efficacy act, required drug to be proven both safe and effective if introduced after 1962, other drugs were grandfathered in as desi-drugs
Requirements of Labels on Commercial Containers
- 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)
Requirements of Labels on Unit Doses
- Name + address of manu. 2. Generic + brand name. 3. Expiration date. 4. Lot #.
Package Inserts
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.
Repackaged drugs expiration
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)
Customized Med Packages (1+ drugs in unit dose blister)
not allowed unless consent of patient, caregiver, or provider (LTC). reduces med errors.
Drug definition
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
Prescription Drug Marketing Act of 1987
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
misbranding definition
dispensing of a drug in violation of labeling requirements, selling an rx drug at retail without rx
adulteration definition
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
OTC drug requirements
same labeling as rx, hospitals only allowed to use in-house, retail pharmacies only allowed to sell to customers
Authority to prescribe
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.
Therapeutic substitution
drugs within same class allowed in retail and hopstial with protocols due to prior consent, pharmacist selects brand unless prescriber notates for the contrary
Generic substitution
Orange book has AB ratings for generic equivalency info, in NC the pharmacist makes substitution based on knowledge (orange book optional)
Refill authorization
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)
Compounding law
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.
Off label uses
prescriber allowed to prescribe drugs off label, ask prescriber for indication in order to counsel patient
ipecac syrup
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.
Poison Prevention Packaging Act of 1970
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.
Childproof packaging
<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.
poison sale laws
sales recorded in front of CV book, requires 1) date 2) name of poison 3) purpose of poison 4) sig + address of buyer
federal anti-tampering act
reactive to tylenol poisoning, required anti-tamper packaging (foil seal, cotton ball, cellophane box)
HIPAA
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.
Federal Drug Recall Class I
drug may cause serious ADRs including death. must notify pts you have dispensed the drug to them; mandatory return of inventory.
Federal Drug Recall Class II
drug may cause temporary or reversible ADR. inventory should be returned, inform pt.
Federal Drug Recall Class III
drug not likely to cause ADRs.
drug labeling rules for preg/breastfeeding
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
Healthcare Fraud, Waste, Abuse Training
required annually by Medicare Part D, allowed to complete online, documentation may be required, includes whistleblowing provisions (self-reporting)
Tamper resistant Rx blanks
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)
Drug Supply Chain Security Act
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
