Federal Law Part 7

What is GRASE/NGRASE?

(not) generally recognized as safe and effective

What are the 4 conditions that PREVENT a pharmacist from refilling a prescription for a nonprescription drug without prescriber authorization?

1. Dose requested is greater than the recommended OTC dose 2. The prescriber has a limit on the number of refills on the original Rx 3. The drug is Sched V controlled substance where the number of refills must be designated by the prescriber 4. The individual state has a set time period limit for refills (AKA can't in FL bc all Rx's are only good for one year)

Name the 4 ways an Rx-only med can become reclassified as OTC

1. if the drug is now an Rx drug, a full NDA requesting OTC status may be submitted to FDA 2. FDA may grant exemption if it deems the Rx only designation is unnecessary for the protection of the public health 3. A supplement to NDA may be filed. FDA will review the relative safety of the drug from previous marketing experience and lack of Hx of ADEs 4. Nonprescription Drug Advisory Committee may recommend that a particular ingredient be converted to nonRx status

If the total amount of sodium present in a product's labeled maximum daily dose exceeds _______, a warning on the label must state "ask a doctor before use if you have a sodium restricted diet"

140 mg

in 2008, CMS got involved with requirements for written, non-electronic prescriptions for outpatient medicaid drugs that were reimbersible by the government. They had to contain _______ tamper resistent features. What are they?

3 Desigend to: prevent unauthorized copying of a completed or blank Rx form Prevent the erasure or modification of information written on the Rx by the prescriber Prevent the use of counterfeit prescription forms ***but remember medicaid is enforced by the state so check state law

Federal regulations require the labeling for OTC products intented for oral admin must indicate the sodium content per dosage unit if the amount present exceeds _______ per single dose

5 mg -- all sources of Na, whether active or inactive ingredients

Manufacturers would most fear the reclassification of their nonRx drug product from Cat A. I to II B. II to I C. I to III D. III to I E. II to III

A. I to II

pharmacies may purchase 95% ethanol (190 proof) for routine compounding by using the form _________

ATF-11

institutions that have a need for great volumes of acohol may choose to purchase it tax-free, since its lower in cost, using form _________

ATF-1447

FDA requires all non-Rx/OTC meds have a "Drug Facts" section on the label. What are the 7 components (IN ORDER)?

Active Ingredient - therapeutic substance and the amount per unit (aka 325 mg/tab) Uses - what it treats/prevents Warnings(SE, when not to use, pregnancy statement, etc) Inactive Ingredients - colors, flavors Purpose - products action or category (ex: cough suppressant, antacid) Directions Other Information - storage, etc

What are the exemptions to the TPA?

Aerosol products nonRx products not accessible to the general public (like in hospitals and other institutions losenges drugs in first aid kits

What is one example of a laxative that NDAC moved to category 2?

Aloe and Cascara Sagrada-containing products

What is a non-dietary ingredient?

And excipient or substance used in the manufacture of a dietary supplement

Basically all OTC systemic drugs have a warning against use in pregnancy, but which one has a special label about the last 3 months of pregnancy?

Aspirin "It is especially important not to use this drug during the last 3 months of pregnancy unless specifically told to do so by your doctor"

The levels of all of the following electrolytes must be listed on OTC labels EXCEPT A. Calcium B. Chloride C. Magnesium D. Potassium E. Sodium

B. Chloride

All of the following are exempt from tamper-evident packaging requirements EXCEPT A. aerosols B. drugs in first aid kits C. 2-piece hard gelatin capsules D. 1 piece hard gelatin capsules E. no exceptions

C. 2-piece hard gelatin capsules

A Physician writes an Rx for a non-prescription drug with no refill instructions. The Pharmacist: A. may not refill the Rx B. May refill only once C. May refill at his/her discression D. must contact the physician before refilling E. Should supply a one-day supply of the drug.

C. May refill at his/her discression

The reports in FAERs are evaluated by clinical reviewers in ____________________________ and __________________ to monitor the safety of products after they are approved by the FDA

CDER (center for drug evaluation and research) and CBER (center for biologics evaluation and research)

if a cosmetic ingredient is not listed in USP/NF, other relevant sources such as _____ may be used

CTFA Cosmetic Ingredient Dictionary - a book compiled by teh Cosmetic , Toiletry, and Fragrande Association (CTFA) and contains many ingredients commonly used in cosmeitcs (surfactants. e,g.)

In 2004, the FDA stated that OTC labels must contain information about the presence/amounts of which 3 electrolytes, and what was the threshold for disclosing (in each dose)?

Calcium - 20 mg Magnesium - 8 mg Potassium - 5 mg

Thanks to the NDAC, 3 OTC classification categories were established. What are they?

Cat I - GRASE for the claimed therapeutic indication Cat II - NGRASE or having unacceptable indications Cat III - insufficient data available to permit final classification

What are some examples of herbs with monographs?

Chamomile, Cranberry liquid preparations, feverfew, garlic, ginger, ginkgo, milk, St. John's wort, saw Palmetto, valerian

The preferred term for packaging that helps prevent contamination of nonRx drug products is A. Child proof B. occlusive C. poison prevention D. tamper evident E. tamper proof

D. tamper evident

What is DSHEA and what is included in their class?

Dietary Supplement Health Education Act Separate from OTC and Rx drugs includes herbals, amino acids, vitamins, minerals, and related supplements

T or F in 2004, the FDA removed the ban on ephedra

F in 2004, the FDA banned the sales of all dietary supplements contianing ephedra, citing that its use posed an unreasonable risk of illness or injury to consumers

T or F the dose of drug administered in homeopathy is usually most often dilutions of 1:100 or 1:10

F usually dillutions of 1:1000 or 1:1,000,000

What is FAERS?

FDA Adverse Event Reporting System - a database that contains info on ADEs and med error reports submitted to FDA; designed to support the FDA's post-marketing surveillance program for drug and therapeutic biologic products

What is a dietary supplement?

Final product

labels for herbal products must contain the standard common names as listed in the reference source, _______ __ ___________, published by the AHPA (American Herbal Products Association)

Herbs of Commerce

The 1998 revision also made some specific rules for capsules, what are they?

If they are two-piece hard gelatin caps, they myst be sealed using tamper-evident technology and that the package containing the capsules has at least 1 tamper-evident feature.

Where did US P publish the manufacturing practices for dietary supplements?

In USP general chapter 2750

do those doses refer to NaCl, or elemental Na?

JUST NA

Under DSHEA, most of the requirements fall upon who with respect to testing and recordkeeping?

Manufacturer of the dietary supplement

Warnings on the label for individuals on electrolyte restricted diets were required if the max daily intake of these 4 minerals exceeded what threshold amounts?

Na - 140 mg Ca - 3.2 g Mg - 600 mg K - 975 mg

The GMP rules do not provide specific guidelines or requirements for tests that a company needs to conduct to verify identity, purity, strength, or composition of ingredients are finished products but instead what may happen?

The company may establish its own testing procedures. The company could test every batch of finish product, or a subset of finished batches a company can perform tests on the non-dietary ingredients or it may rely on a certificate of analysis obtained from the supplier of the non-dietary ingredient

What do these monographs include?

The portion of the plant used, it's botanical characteristics, and appropriate assay procedure for ingredients. it does not describe the therapeutic use of the herbs

What rules do the suppliers of the dietary ingredients have to conform to?

The suppliers are not required to conform to the new GMP rules since the responsibility of determining the quality belongs with the manufacture of the dietary supplement. The exception happens when a company manufactures a dietary ingredient and then simply repackage it as a final product. If this is the case they are subject to GMP rules

USP/NF has developed monographs for some botanicals that seem to have therapeutic efficacy. To be admitted into the official compendium, what must happen?

The urban must have an FDA approved use or a USP DI panel recognized use.

What is the dietary ingredient?

Vitamin, mineral, Herb, or other botanical, and amino acid, or a dietary substance to supplement the diet By increasing the total dietary intake, or A concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.

Drugs can be marketed WITH/WITHOUT their safety proven

WITHOUT Drugs currently on the market do not have to be proven safe. It is the responsibility of the FDA to prove that a product is unsafe. However the manufacturer must provide reasonable assurances that no ingredients in the product presents a significant or unreasonable risk for illness or injury

Drugs can be marketed WITH/WITHOUT their efficacy proven

WITHOUT FDA or FTC would have to challenge products after they had been introduced to the market if evidence surfaced that they are ineffective for the advertised or labeled use

if an unapproed color additie is used in the formulation of a cosmetic, the product wwill be classified as being a. adulterated b. misbraded

a adulterated if the drug poses safety probem to the general public, it is considered as misbranded

upon formal request, to whom must the manufacturer of a herbal product submit data supporting hte claims for the product? (select all that apply) a. FDA or FTC b. Pharmacists c. consumers

a. FDA or FTC

regulation of advertising and labeling of cosmeitcs basically falls under the jurisdiction of a. FTC b. FDA

a. FTC

nomenclature for herbals is primarily based upon which of thw following referece sources? a. Herbs of Commerce b. Homeopathic Pharacopeia c. German Commision on Herbs of Choice D. USP e. USP/NF

a. Herbs of Commerce

which of the following statements is true? (select all that apply) a. commercial herbals are categorized as dietary suppplements b. commercial herbals may be categorized as nonprescription drugs c. none of the herbals use in the US are recognized in the USP/NF

a. commercial herbals are categorized as dietary suppplements only

fluoridated toothpaste, medicated mouthwas, or anti-dandruff shampoos a. cosmetics b. nonprescription products

a. cosmetics the book states that they are cosmetics, although they are on the boarder between being classifeid as cosmetics or nonprescrition products.

Requires pre-marketing approval from the FDA a. drugs b. cosmetics c. both

a. drugs only cosmetics do not require premarketng approval from FDA

how many a prescribers order for an alcohol containing beverage for an institutionlized cleint be handled? (select all that apply) a. institution may buy the alcohol containing beverage, furnish it to the client, and then bill the patient b. the hospital pharmacy may give the patients relatives permission to bring in alcohol for the patient

a. institution may buy the alcohol containing beverage, furnish it to the client, and then bill the patient b. the hospital pharmacy may give the patients relatives permission to bring in alcohol for the patient both of these are acceptable options. the only options

ephedra may still be found in which of the following produts? (select all that apply) a. prescription drug products b. non prescription drug products c. dietary supplements

a. prescription drug products b. non prescription drug products

manufacturers of supplements are not permitted to make which of the following claims (select all that apply)? a. the product will diagnose b. the product will treat c. the product will cure d. the product will prevent a disease e. the product will improve urinary flow

a. the product will diagnose b. the product will treat c. the product will cure d. the product will prevent a disease a claim that saw palmetto will improve urinary flow or that it is for the prostate, is acceptable. A statemetnt hta tit will reduce or cure the size of a enlarge prostate is not acceptable.

Which name of herbals Must be used according to federal regulations for the labeling of botanical ingredients in dietary supplements if it is listed in Herbs of Commerce? a. the standardized common herbal name b. the latin name c. both are required

a. the standardized common name must be used, while the inclusion of the latin name is optional e.g., the name of Eleuthero for the herb Eleutherococcus senticosus must be used rather than Siberian Ginseng.

This company violates the GMP rules, what is the product considered?

adulterated

what is Specially Denatured Alcohol (SDA)?

another avaiable form of tax-exempt alcohol it is a secific formula of grain (ethyl) alcohol that have been rendered unsuitabe for use as a beverage by the additon of denaturants such as sucrose octaacetate, brucine or butyle alchohl

what is the overriding factor in determinining a products stats as a cosmetic or a nonprescription? a. the ingredients b. the claims that are made for the product

b the claims that are made for the product, especially on the label

controls the sale of alcohol a. FDA b. Bureau of Alcohol, Tobacco and FIrearms

b. Bureau of alcohol, tobacco, and firearms

the ingredient names listed on labes of cosmetics must bt he generic names listed in a. Herbs of Commerce b. USP/NF c. FD&C act d. none of the above

b. USP/NF

Which is *not* required for homeopathic products? a. manufactured according to GMP b. an expiration date on the package c. labeling includes ingredientnames, amounts and directions d. english name must be provided

b. an expiration date on the package while homeopathic drugs must be manufactured under GMP standards, they dot no have to have an exp date on package

the general guideline for listing ingredients on a cosmetic product label consists of listing the additives a. and active ingredients intermixed but inthe alphabeticl order b. and active ingredeints intermixed but ranked by decreasing concentrations c. and active ingredients intermixed but ranked by increasing concentraitons d. separately from the active ingredeints by increasing concentration e. separately from the active ingredeints by decreasing concentration

b. and active ingredeints intermixed but ranked by decreasing concentrations

which is required of cosmetic manufacturers? (select all that apply) a. be manufacturered according to GMP b. be manufacturered under sanitary conditions c. cosmetics have to be tested for safety

b. be manufacturered under sanitary conditions *only* they do not have to meet the rigorous requirements of the FDAs GMP, butstill obligated to manufacter under sanitary conditions. the FDCA act of 1938 states that they do not need to have tests for safety, but any cosmetic that poses a safety problem to the general public will be considered as being misbranded

the labels of cosmeitc products must contain the names of ingredients listed in ____________ order of predominance a. ascending b. descending

b. descending (water may be listed as first ingredient, while the active ingredient may be further down the list)

It is required that this name be provided on homeopathic labels a. latin name b. english name

b. english name while many ofthe durgs were originally labeled by their latin name, it is now required that their english name be provided

must contain a retail liquor dealers stamp (select all that apply) a. pharmacy purchases 95% ethanol (190 proof grain alcohol) b. pharmacy sells alcohol in the form of a beverage c. pharmacy sells alcohol in the form of an elixir

b. pharmacy sells alcohol in the form of a beverage only

which one of the folowing is the basic goal for the 2014 suncreen innovation act? a. speed marketing of new suncreen products b. speed approval of new sunscreen ingredients c. establish a newcode for screen efficacy d. provide funds for developing new sunscreen ingredients e. redue cost of sunscreen produts

b. speed approval of new suncreen ingredients

A practitoner of Traditional Chinese Medicine may sell ephedra containing products if: a. A Prescription is presented b. there is no label claim that the product is a dietary supplement c. the customer is examined by the seller d. less than a 10 day supply is sold e. the product is marked for long term use for weight loss

b. there is no label claim that the product is a dietary supplement

which of the folloiwng organizations is repsonsible for establishing names fo ingredients used in cosmetic formulations? a. ASHP b. AHPA c. CTFA d. HCFA e. RDA

c. CTFA

which is *not* a condition that must be met in order to use tax-free alcohol a. it is limited to medicinal or scientific use, or in pt treatment b. may not be sold or loaned to other pharmacies or physicains offices c. may not be sold to outpatients (by iteself or a component of something else) under any circumstances d. a running, accurate inventory msut be kept for all alcohol in stock e. containers of alcohol, usually in 10 or 55 gallon drums, mjst be stored in a securely locked, fire resitsant storeroom

c. may not be sold to outpatients (by iteself or a component of something else) under any circumstances *an exception to this* permits nonprofit clinics to disepnse medicines made with tax-free alcohol provided the client is not charged for the medicaiton

in cosmetic ingredients where the quantities present are 1% or less, these may be listed at the bottom in ________ order a. ascending b. descending c. random

c. random

a pharmacist may sell herbals provided that (select all that apply) a. the pt is properly counseled with respect to their use b. the consumer is cautioned to use the product for not more than 2 weeks c. there are adequate directions on the package for patient use

c. there are adequate directions on the package for patient use' only

What does the designation "low sodium" mean?

contains 140 mg or less of sodium in the labeled maximum daily dose

What does the designation "very low sodium" mean?

contains 35 mg or less of sodium in the labeled maximum daily dose

What does the designation "sodium free" mean?

contains 5 mg or less of sodium in the labeled max daily dose

The ban on ephedra includes the following (select all that apply) a. prescription drug products b. nonprescription drug products c. conventional foods such as herbal teas d. dietary suppplements e. traditional chinese medicine

d. dietary suppplements *only* it does not apply to prescription or nonprescription drug products or to conventional foods such as herbal teas. italso doesnt apply to products that are prepared or used for traditional chinese medicine, since this practice uses ephedra for temprary respiratory conditions, not chronic long term use for weight loss

a client in a pharmacy complains about her hypersensitivity to many ingredients found in cosmetic lotions. when reading label of suncreen lotion, whic oneof hte following ingredietns is not required to be listed by the manufactuer? a. antmicrobial preservative b. coloring agent c. sunscreen agent d. perfuming oil e. water

d. perfuming oil

What about if the formulation is rectal? They must disclose if the dose of Na content is 5 mg or more if the drug contains _______ or _________.

dibasic Na phosphate and/or monobasic Na phosphate

What was the original function of the Nonprescription Drug Advisory Committee?

evaluate all the nonRx products on the market. The subcommittees (based on specific therapeutic categories) submitted conclusions to FDA.

What are some other categories a label usually contains?

exp date lot or batch code name and address of manufacturer, packer, or distributor net quantity of contents what to do if an overdose occurs

What is FAERs a useful tool for?

looking for new safety concerns with a med on the market evaluating a manufacturers compliance with reporting regulations responding to outside requests for information

what are nutraceuticals?

may be defined as food products including dietary supplements, herbals, and processed foods that provide health or medical benefits, including prevention or treatment of diseases *note*; ongoing dialogue between FDA nad manufacturers of these, as to the interpretation of allowable claims, it is unlijely tha tany specific q's will be asked about this on MPJE

If any of the above listed info is missing, the product is considered ____________

misbranded

SDAs are often used in pharmaceutical processing and in commercial produts such as ___________

mouthwashes

Do these medicaid rules apply to DME, prosthetics, orthotics, and diabetic strips?

nope! ***but remember medicaid is enforced by the state so check state law

what does te Sunscreen Innovation Act of 2014 state?

requires FDA to respond quickly to requests for approval of pending ingredietns for OTC sunscreen products

OTC status is granted to drugs and drug products that have been shown to be ____________________, ____________________, and __________________.

safe for use without a physicians supervision for conditions suitable for self-diagnosis and have adequate directions for self-use

What must the directions list?

specific age categories that can use it how much to take how, how often, and how long to take

based on which Act did the FDA claim that dietary supplements containing ephedra or its alkaloids are adulterated since they present an unreasonable risk of illness or injury based upon their recommended use?

the DIetary Supplenent Health and Education act (DSHEA)

what is contained in the Herbs of Commerce?

this reference contains standardized common herbal names as well as corresponding latin binomial designations for thousands of herbal species

cosmetic products, especially those intended or use in what parts of the body, must be packaged in tamper resistant packaging?

those intended for use in body cavities (mouthwash and vaginal products)

What is the intent of the TPA?

to prevent intentional contamination of OTC products

What are some things FDA might do as regulatory action to concerns noted form VAERs reports?

update product labeling info restrict use of the drug communicate new safety info to the public remove from market (rare)

in 1998 they clarified TPA, how?

using the term "tamper evident" packaging. So consumers were aware of potential tamperings, but not implying that it is ahrd to open or tamperPROOF

Reporting of ADEs and med errors by health care professionals and consumers in US is *VOLUNTARY/MANDATORY*?

voluntary However, if a manufacturer receives a report, it is REQUIRED to send it to the FDA.

a cosmetic hand lotion consists of an oil-in -water emulsion. the first ingredient listed on its label is most likely to be what?

water

there are a large number of formulas for SDAs, usually designated as SDA _____, SDA _____, etc..

SDA 40A SDA 23H.. etc

What instigated the passing of the Tamper-Resistant Packaging Act?

Several instances of deliberate addition of poisons to commercial nonRx drugs

T or F If a herb is *not* listed in the Herbs of Commerce, the manufacturer must include the herbs latin name on the label

T

T or F homeopathic products must meet the labeling requireents of usual drug products including ingredient names, amounts and directions for use

T

T or F the FD and C act of 1938 recognized the homeopathic pharmacopeia of the united states (HPUS) as an official compendium

T drug products that use an official name designation found in the HPUS must meet all of its compendial standards. otherwise the drug product is misbranded or adulterated

T or F an exception to cosmetic labeling requirement are those that are used in the professional setting (e.g. cosmetics not intended for retail sale)

T such as by rofessinal hairdressers

T or F some of the drugs found in the homeopathic formulas are also official in the USP/NF

T the drug must meet the stricter standards found in the USP/NF