Texas Pharmacy Law Set of 460 answered Questions 100% correct

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What is the Food and Drug Act of 1906? - ANSWER Prohibited adulterated or misbranded food and drugs Established the FDA What is the Food, Drug, and Cosmetic Act of 1938? - ANSWER Drugs must be p... roven safe to the FDA prior to marketing Established the FDA as law of land referring food, drugs, cosmetics Granted authority to FDA for factory inspections and warnings of habit-forming drugs What are the Durham-Humphrey Amendments of 1951? - ANSWER Established two types of drugs: OTC and Rx Required prescription medications to bear "Caution: Federal law prohibits dispensing without a prescription" Mandated that OTCs must have "adequate directions for use" Authorized verbal prescriptions and refills What is the Kefauver-Harris Amendment of 1962? - ANSWER Drugs must be safe AND effective (this was backdated to 1938) Established Good Manufacturing Practice Gave FDA jurisdiction over prescription drug advertising What strength of ibuprofen is OTC? - ANSWER 200 mg 400, 600, 800 mg are Rx What is the Prescription Drug Marketing Act of 1987? - ANSWER Bans the reimportation of prescription drugs and insulin products produced in the US (except by the manufacturer) Once it leaves the US, it cant come back Bans the sale, trade, or purchase of prescription drug samples Mandates the storage, handling, and record keeping requirements for prescription drug samples Can pharmacies provide samples? - ANSWER NO Exception: pharmacies owned by charities, or by a city, state or country government who provide care to indigent or low income patient may provide samples at no cost (CANNOT SELL, ONLY GIVE) What is the Drug Quality and Security Act of 2013? - ANSWER Addressed two major topics: Large scale compounding by pharmacies and establishment of a uniform track and trace system for prescription drugs What is the Drug Compounding Quality Act (DCQA)? - ANSWER Establishes 503A vs 503B facilities/pharmacies 503A: pharmacies that are not registered as an "outsourcing facility: May only compound pursuant to an individual prescription or medication order Only permitted to do limited anticipatory compounding Primarily regulated by the states and are subject to 797 standards 503B: "outsourcing facilities" that are permitted to compound without receiving prescriptions or orders Primarily regulated by FDA and are subject to CGMP Exempt from adequate directions for use and drug track and trace provisions What is the Drug Supply Chain Security Ac (DSCSA)? - ANSWER Track and Trace Act Provides framework for a national electronic track and trace system for Rx drugs as they move through the supply chain Exempt products: blood components, radioactives, IV products, dialysis solutions, gases, compounded drugs, medical convenience kits, sterile water (THINK: THIS THINGS ARE TIME SENSITIVE, NO TIME TO WORRY ABOUT TRACKING) Manufacturers are required to provide "Transaction data" and pharmacies are required to receive it and provide it if they are further dsitributing Any entity that is distributing must be licensed with DSCSA. The only exceptions are: when distributing between two entities under same ownership, providing product to another dispenser on a patient specific basis, when distributing under emergency medical reasons, when distributing minimal quantities to a license practitioner for office use If a product's strength is less than what is represented on the label, is it adulterated or misbranded? - ANSWER Could be both Based on previous exams you should answer adulterated (which makes less sense) Does a pharmacist have to abide by misbranding laws? - ANSWER No, they abide by prescription labeling laws per the state Misbranding refers to packaging information that the manufacturer must abide by How are inactive ingredients ordered? - ANSWER Alphabetically What is the labeling requirement for Yellow No. 5 (TARTRAZINE) and No. 6? - ANSWER Must disclose allergic reaction potential in "Precautions" What is the labeling requirement for aspartame? - ANSWER Must disclose "Phenylketonurics: contains phenylalanine __ mg per ___" in "Precautions." What is the labeling requirement for sulfites? - ANSWER Must contain an allergy warning in the "Warning" section What is the labeling requirement for mineral oil? - ANSWER Requires warning to only take at bedtime and not to be used in infants unless under supervision of physician Cannot encourage use during pregnancy What is the labeling requirement for wintergreen oil? - ANSWER Contains methyl salicylate Any drug containing more than 5% methyl salicylate must include warning that use outside of directions may be dangerous and should be kept out of children What is the Prescription Drug Marketing Act of 1987? - ANSWER Bans the reimportation of prescription drugs and insulin products produced in the US (except by the manufacturer) Once it leaves the US, it cant come back Bans the sale, trade, or purchase of prescription drug samples Mandates the storage, handling, and record keeping requirements for prescription drug samples What is the labeling requirement for isoproterenol inhalation preparations? - ANSWER Do not exceed dose and contact doctor if difficulty in breathing persists What is the labeling requirement for potassium salt preparation for oral ingestion? - ANSWER Warning regarding nonspecific small bowel lesions consisting of stenosis, with or without ulceration What is the labeling requirement for ipecac syrup? - ANSWER "For emergency use to cause vomiting in poisoning. Before using, contact physician, poison prevention center, or hospital emergency room immediately for advice." Must have warning to keep out of reach of children What is the typical dose of ipecac syrup? - ANSWER 15 mL in individuals over 1 year of age What is the max size of an ipecac syrup bottle? - ANSWER 30 mL (1 oz) What is the labeling requirement for phenacetin (acetophenetidin)? - ANSWER Must contain warning about possible kidney damage when taken in large amounts What is the labeling requirement for salicylates? - ANSWER Warning regarding Reye's syndrome Retail containers of 1.25 grains (81 mg) may not contain more than 36 tablets What is the labeling requirement for alcohol? - ANSWER Internal analgesics and antipyretics (APAP, ASA, IBU, naproxen, ketoprofen) are required to have warning for persons containing 3 or more alcoholic beverages per day and to consult with doctor before taking What is the labeling requirement for APAP? - ANSWER Must have "acetaminophen" prominently displayed Warning about liver toxicity Warn not to use with other products containing APAP and to talk to doctor before using with warfarin What is the labeling requirement for NSAIDs? - ANSWER Must include "NSAID" Must contain warning for "stomach bleed" What OTC products are exempt from tamper-evident packaging? - ANSWER Dentrifice, dermatological, insulin, lozenge products Tamper-resistant or tamper-evident? - ANSWER Tamper-evident What are the requirements of a pharmacy repackaging OTC for sale? - ANSWER Must follow CGMP requiremtns Must provide tamper-evident packaging When repackaging an OTC product, what labeling requirements must be met? - ANSWER Prescription drug labeling requirements OTC labeling requirements do not need to be met How long are refills valid on an OTC product ran as a prescription? - ANSWER 1 year What are the differences between FDA recalls? - ANSWER Class I: reasonable probability serious adverse effects on health or death with occur Class II: temporary or reversible adverse effects; probability of serious adverse effects is remote Class III: not likely to cause adverse health consequences Can the FDA order a drug recall? - ANSWER No, it has to be done by the manufacturer or distributor They can order recalls on medical devices FDA can seize products and raid, so most companies abide by FDA request for drug recall Who regulates prescription drug advertising? - ANSWER FDA (Kefauver-Harris) Who regulates OTC drug advertising? - ANSWER FTC Can you, as a pharmacy, advertise drug prices? - ANSWER Yes, as long as you don't provide info on efficacy, safety, indications You can include brand, generic, strength, dosage form, price per specific quantity May offer other services as long as not misleading The price stated must include all charges to consumer (mailing, delivery fee may be stated separately)s What medications require a PPI? - ANSWER Oral contraceptives Progesterone-containing products Estrogen-containing products When do hospitalized or institutionalized patients require PPI? - ANSWER First administration and every 30 days thereafter Failure to provide PPI-- adulterated or misbranded? - ANSWER Misbranded What is the difference between Medguide and PPI? - ANSWER Medguide is just the printout that pharmacies provide, not the PPI stuck to manufacturer's bottle Over 300 drugs require medguide Institutionalized patients don't require medguide Required if labeling could prevent serious adverse events, serious risks relative to benefits, adherence is crucial For the sale of isotretinoin, who must be enrolled in iPledge? - ANSWER Everyone-- prescriber, patient, pharmacy, distributor Who assumes the responsibility for pregnancy counseling during isotretinoin fills? - ANSWER The prescriber The prescribers are the ones that enter negative pregnancy screens How is isotretinoin dispensed? - ANSWER Blister packs which cannot be broken Max supply: 30 days No refills How do you break down an NDC number? - ANSWER 4/5 - 4- 2 First set: manufacturer Middle set: specific drug Last last: package code Does the FDA require an NDC code? - ANSWER No Also, an NDC code does not indicate a drug is approved by the FDA It is being proposed that the FDA require NDC but is not yet official What is the FDA Orange Book? - ANSWER The primary source for determining generic equivalency A___: drugs are therapeutically and pharmaceutically equivalent B__: drugs are NOT therapeutically and pharmaceutically equivalent AB: products with actual or potential problems, but adequate science has established bioequivalence (drugs are equivalent but there may be problems) What is the FDA Purple Book? - ANSWER A list of biologics that are considered biosimilars and provide interchangeability Products must be deemed "interchangeable" to be substituted in Texas What did the Poison Prevention Packaging Act do? - ANSWER Established standards for child-resistant containers All prescriptions and some OTC must be child-resistant, unless exempt Who can request a non-child resistant container? - ANSWER The patient or prescriber Only the patient can provide a blanket request for all future prescriptions The prescriber can only request for an individual prescription Is it required to have non-child resistant container requests in writing? - ANSWER No, but it is good practice What products are exempt from child-resistant packaging? - ANSWER Bulk containers not intended for household use Packages designed for elderly Oral contraceptives SL NTG SL or chewable isosorbide dinitrate Effervescent./granule APAP or ASA Cholestyramine packets EES Prednisone, methylprednisolone, betamethasone (dose-paks) mebendazole Aerosol containers Pancrelipase and sucrose preparations (these come in packets) Hormone replacement therapy What is the Federal Hazardous Substances Act of 1966? - ANSWER Protects customers from hazardous and toxic substances What is the Federal Hazard Communication Standard? - ANSWER Requires pharmacies to carry SDS (formerly MSDS) for all hazardous chemicals, have written Hazard Communication Plans, appropriate training for handling of hazardous chemicals Enforced by OSHA What are the requirements of CMS? - ANSWER Tamper-RESISTANT prescriptions (the paper cannot be copied) Long-term care patients must receive MTM every 30 days by a consultant pharmacist Can controlled medications be mailed? - ANSWER Yes, but the prescription level must meet all requirements The prescription must be contained in a manner that is free of ANY markings that would suggest its contents (including address of pharmacy) Can controlled substances be mailed to other DEA registrants? - ANSWER Yes, provided they are in a plain container with no markings Is alcohol tax free? - ANSWER Only 95% ethanol, used for scientific, medical, or compounding purposes is tax fee The user must have a permit The alcohol cannot be resold or used in beverages Do you need written acknowledgement of receipt of HIPAA Notice? - ANSWER Need to make a good faith effort to obtain The Notice MUST be provided upon first service delivery Who may a pharmacy divulge PHI to? - ANSWER FDA for adverse event reporting, oversight agencies such as state boards of state drug monitoring programs, law enforcement agencies Other disclosures, such as for marketing, must require signed authorization If patient would be receiving compensation for authorization, they must be notified Are refill reminders considered marketing? - ANSWER No How long do pharmacies have to comply with patient request of PHI? - ANSWER 30 days, but may extend an additional 30 days Who in the pharmacy is responsible for developing and implementing HIPAA procedures - ANSWER Privacy Official- can be anyone Must also designate a contact person to receive complaints, this may also be the Privacy Official What is the HITECH Act? - ANSWER Beefed up HIPAA How long do covered entities have to notify individuals of a breach of their unsecured PHI - ANSWER 60 days A breach does mean an inadvertent disclosure from one authorized person to another A breach is not considered if theres good faith belief that the PHI will not further acquired, accessed, retained Do you have to log breaches of pHI? - ANSWER If fewer than 500 individuals, yes Must notify HHS annually of breaches (in addition to notifying effected individuals within 60 days of breach) A breach of more than 500 individual's PHI requires? - ANSWER Notification of Secretary of HHS and prominent local media Individuals within 60 days What class is dihydromorphine? - ANSWER C-I What class is lysergic acid deiethylamide? - ANSWER C-I This is LSD What class is mescaline? - ANSWER C-I What class is methaqualone? - ANSWER C-I What class is dihydrocodeine? - ANSWER C-II What class is codeine? - ANSWER By itself (or only combined with an inactive such as simple syrup or water): C-II In combination with ASA, APAP: C-III What class is phenmetrazine? - ANSWER C-II This is an amphetamine 2 people MET What class is pentobarbital? - ANSWER Oral: C-II Suppository: C-III What class is secobarbital? - ANSWER Oral: C-II Suppository: C-III What class is amobarbital? - ANSWER Oral: C-II Suppository: C-III What class is glutethimide? - ANSWER C-II Two Glutes, Two thighs This is an old school alternative to barbs to treat insomnia What class is phencyclidine? - ANSWER C-II This is PCP-- THERE IS APPROVED USE FOR PCP (used to be an IV anesthetic) What class is phendimetrazine? - ANSWER C-III This is a stimulant, do not confuse with phenmetrazine, which is a C-II Dime leads to a 3 ball What class is chlorphentermine? - ANSWER C-III This is a stimulant What class is benzphetamine? - ANSWER C-III This is a stimulant What class are anabolic steroids, such as testosterone? - ANSWER C-III What class is ketamine? - ANSWER C-III K takes 3 pencil strokes What class is paregoric? - ANSWER C-III What class is phenobarbital? - ANSWER C-IV PHeno = Phour Do not confuse with pentobarbital which is C-II/III for oral/suppository What class are benzodiazepines? - ANSWER C-IV What class is soma? - ANSWER C-IV What class is tramadol? - ANSWER C-IV What class is chloral hydrate? - ANSWER C-IV What class is phentermine? - ANSWER C-IV Think: BMI 40 is when phentermine is indicated What class is Robitussin AC? - ANSWER C-V What class is Phenergan with Codeine? - ANSWER C-V What class is clorazepate? - ANSWER C-IV What class is pregabalin? - ANSWER C-V What class is lacosamide? - ANSWER C-V Anti-epileptic What class is Lomotil? - ANSWER C-V Atropine/diphenoxylate Who schedules drugs? - ANSWER Both federal and state can schedule drugs Federal: Attorney General, but must obtain recommendation from FDA State: the Commissioner of the TX Department for State Health Services, but cannot override state legislature Is there a state controlled substance registration in Texas? - ANSWER No You only need to be registered with the DEA How often must dispensers, both pharmacies and practitioners, register with the DEA? - ANSWER Every 3 years What is the first letter of a DEA number for practitioners? - ANSWER A, B, F, G (for Department of Defense contractors) A Full Blow Gynecologist Practioner would be defined as: physician, dentist, veterinarian, optometrist Who are considered mid-level practioners and what does their DEA number start with? - ANSWER M Nurse practitioners, PAs, ambulance services, animal shelters, veterinary euthanasia technicians Do you need a DEA number to conduct research? - ANSWER Yes Need one for C-Is and one for C-2-5s How do you verify a DEA number? - ANSWER Add numbers 1, 3, 5 Add numbers 2, 4, 6-- then multiply by 2 Add steps 1 and 2 together, last digit of sum should be the same as last digit of the DEA number Does each pharmacy need a DEA registration? - ANSWER Yes Think you'll be ordering from each location What DEA form is the application for registration? - ANSWER 224 Think: Kobe Bryant (24) needs to signup for DEA number because of his dealing Who is exempt from a DEA number? - ANSWER Agents of the registrant [Show More]

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