Law - Exam #1 Readings Master Set
What is the (long and multi-part) definition of a drug?
(1) An article recognized in the official compendium or any supplement of the official compendium, *and* (2) An article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" in man or other animal, *and* (3) An article (other than food) intended to affect the structure or any function of the body in man or other animal, *and* (4) Articles intended for use as a component of any article specified (1), (2), or (3) (Notice the "and" between each clause. A substance must meet each clause to be considered a drug.)
What drugs require special packaging?
- Controlled substances (controlled drugs) in a dosage form intended for oral administration - Prescription drugs in a dosage form intended for oral administration - OTC drugs approved after 2002 that were initially prescription - OTC medications intended for oral administration including acetaminophen, aspirin, ibuprofen, loperamide, diphenhydramine, and naproxen - Sample packages for medications that generally require special packaging
What are the two types of warrants that inspectors can obtain to inspect a pharmacy?
-Administrative Inspection Warrant (AIW) -Search Warrant Warrants are issued for probably cause for entry. AIW has a lower threshold for probable cause, and anything that is considered a valid public interest can lead to one being issued.
What are the six criteria that can lead to a drug being considered hazardous under USP 800?
-Carcinogenicity -Teratogenicity or developmental toxicity -Reproductive toxicity in humans -Organ toxicity at low doses in humans or animals -Genotoxicity -New drugs that mimic existing hazardous drugs in structure or toxicity
What did the Dietary Supplement Health and Education Act of 1994 do?
-Established the dietary supplement category of substances -Significantly altered the FDA's authority to regulate dietary supplements
What agencies can inspect pharmacies?
-FDA -DEA -State Board of Pharmacy (BoP)
When do drugs not need to be dispensed in child-resistant packaging?
-If not an oral formulation -If the patient or prescriber has provided a waiver for non-child-resistant packaging -Specific drugs
What is required for OTC packaging as a result of the Federal Anti-Tampering Act of 1983?
-One or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred -The design of the packaging must be distinctive and difficult to replicate -If not distinctive, the package must have one or more indicators or barriers to entry that use an identifying characteristic like a trademark, pattern, phrase, or picture -They can use a two package system like a bottle of tablets in a box In addition: -Any product using a capsule must seal the capsule. This seal prevents a bad actor from opening and replacing the capsule contents; Most manufacturers use a solid capsule instead of a traditional capsule -For capsules, the product must also identify the technology used to seal the capsule -Packages must have a prominently placed statement on the package identifying all the tamper-evident features
Who can decide or request that medication not be placed in child-resistant packaging?
-Patient -Patient representative -Prescriber -The CPSC Not pharmacists
What are the four types of prescribers who have prescriptive authority in every state? What are they also known as?
-Physicians (MD/DO) -Dentists (DDS/DMD) -Podiatrists (DPM) -Veterinarians (DVM) AKA - Full prescribers Someone who is one of these types of prescribers can have their prescriptions filled anywhere in the US if they are licensed anywhere in the US (including Puerto Rico and Guam)
What new (as of 2017) pregnancy categories are used for newly approved medications instead of the old A, B, C, D, X categories?
-Pregnancy -Lactation -Females and males of reproductive potential They're listed in the package insert. It's done this way to try to make the pregnancy categories easier to understand.
What five crimes were defined by the Federal Anti-Tampering Act of 1983?
-Tampering or attempting to tamper with a products packaging or labeling -Tainting a product -Communicating false information that a product has been tainted -Threatening to tamper with a product -Conspiring to tamper with a product
What are the official compendia for defining a drug? (the definition of a drug references them in the first clause)
-The United States Pharmacopeia (USP) -The National Formulary (NF) -The Homeopathic Pharmacopeia of the United States (HPUS) USP and NF have now been combined into a single compendium known as the USP-NF
When requesting an inspection, what is a DEA agent required to show you? How does this differ from an FDA inspection?
-The purpose of the visit -Their credentials -Written notice of inspection to the pharmacy owner or pharmacist in charge Note that these are what's required specifically for DEA inspections. For FDA inspections, they need to show credentials and written notice, but they do NOT need to tell you the purpose of the visit.
What 7 things MUST be included on the label of a drug dispensed on prescription? (According to federal law. This is ignoring special stuff for controlled substances.)
1. Name and address of the dispenser (the pharmacy) 2. The serial number of the prescription (the prescription number) 3. Date of the prescription OR date of its filling 4. Name of the prescriber These next three are only required under specific circumstances: 5. If stated on the prescription, name of the patient 6. If contained on the prescription, any directions for use 7. If contained on the prescription, any cautionary statements
What are the four different types of REMS?
1. Patient-friendly labeling like medication guides (MedGuides) 2. Communication plans for disseminating information to healthcare practitioners about the risks of the drugs and the REMS program in place 3. Elements to assure safe use (ETASU). ETASUs are required activities or clinical interventions that must be done before prescribing, dispensing, or receiving a product. An ETASU could require practitioners to document information, agree to carry out specific steps to mitigate the risks, or ask a patient to complete steps before receiving medication. 4. An implementation system. This strategy reviews the ETASU measures to ensure that it's adequately mitigating risks, that providers and patients adhere to requirements, and that no changes are required to improve risk mitigation of implemented strategies.
Which specific, oral medications don't require child-resistant packaging? (There's 12 of them if that helps.)
1. Sublingual nitroglycerin 2. Sublingual or chewable isosorbide dinitrate 3. Erythromycin granules for oral suspension or erythromycin suspension containing 8 mg or less of erythromycin or tablets in packages containing 16 mg or less of erythromycin 4. Cyclically administered contraceptives 5. Cholestyramine in powder form 6. All dose forms of potassium of 50 mEq or less 7. Betamethasone in manufacturers' dispenser packages, containing 12.6 mg or less 8. Prednisone tablets in packages of 105 mg or less 9. Medroxyprogesterone tablets 10. Methylprednisolone tablets in packages of 85 mg or less 11. Colestipol powder in packages of 5 g or less 12. Mebendazole in packages of 600 mg or less
What are the three phases of human trials in the clinical investigation phase of the IND?
1. The first introduction of the drug into human subjects. These studies take place in healthy volunteers and are designed to better understand the pharmacokinetics, pharmacologic effects, and adverse effects. 2. The first introduction of the drug in patients with the disease. These studies "evaluate the effectiveness of a drug for a particular indication" and "determine the common short-term side effects and risks associated with the drug." 3. "Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug to provide an adequate basis for physician labeling." Phase 3 has the most participants of any phase, usually in the thousands.
What are the main points of DEA form 82?
1. You have the right to require the DEA to get an administrative inspection warrant (AIW). 2. You have the right to refuse an inspection. This refusal triggers them to get an AIW, so the first two rights go together. 3. Anything incriminating found can be seized and used against you in prosecution. This statement is an important reminder, so you can't say that you didn't know about this, and if you had, you wouldn't have consented. 4. You'll get a copy of the notice. 5. You may withdraw your consent at any time during the inspection. If you withdraw consent, the DEA will get an AIW to finish the inspection, just like if you refused consent at the start. Once you've reviewed the notice, you sign the form and note your position. Keep in mind that there may be restrictions on who can sign an NOI, like an owner or pharmacist-in-charge (PIC).
How long must records relating to the PDMA be kept?
3 years (If a practitioner requested drug samples, records of the request must be kept for 3 years. Although the request has to be written, the records can be digital.)
What is the FDA's letter rating system for therapeutic equivalence?
A and B A-rated products are bioequivalent to the RLD and are therefore therapeutically equivalent to that product B-rated drugs are not bioequivalent and therefore are not therapeutically equivalent to the RLD Simply, A-rated products can be substituted with one another, while B-rated products cannot be substituted
What is the definition of a *prescription* drug?
A drug intended for use by man which: (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; *or* (B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug
What is the big, 5 part definition of adulteration?
A drug or device shall be deemed to be adulterated— (a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice... or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe... or it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe. (b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium... No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label... (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefore ... (j) If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
What is the definition for *DESI* drugs?
A drug that entered the market between 1938 and 1962 and that we assumed was safe based on longevity on the market, but that had not been proven to be effective. Manufacturers had to prove that these drugs were effective for their listed indication or remove them from market. Note how that differs from pre-38 drugs, which were allowed to remain on the market without having to be proven effective.
What is the definition for *new* drugs?
A drug that is not generally recognized as safe and effective for the condition(s) or in the dosage form it would be prescribed under; or A drug that has been recognized as safe and effective but has not been used in the condition(s) or in the dosage form for a sufficient amount of time (It doesn't refer to newly available drugs. It refers to drugs that haven't yet gone through the pre-market approval process.)
What is the definition for *pre-38* drugs? What's another name for them?
A drug that was introduced before 1938 and was still on the market in 1962. These drugs were assumed to be safe for use and effective for their indication based on the longevity on the market. Also known as "grandfathered" drugs, because they were grandfathered onto the market.
What is the definition for dietary supplements?
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a), (b), (c), (d), or (e).
What is a statute?
A written law enacted by the legislature (Literally just another name for a law)
When can AIWs be served? When can search warrants be served?
AIW - During business hours Search Warrants - Any time; Even when the pharmacy is closed
What is an ANDA?
ANDA - Abbreviated New Drug Application It's an application submitted to the FDA to approve a therapeutically equivalent product to a product already on the market. More simply, it's the approval pathway for a generic drug.
What is an ANDA?
Abbreviated New Drug Application - Used by generic manufacturers to prove bioequivalence and proof of acceptable manufacturing practices and controls (If a generic manufacturer wants to get their meformin put on the market, they don't need to show that metformin works. Metformin has already been shown to work. They just need to show that they can effectively manufacture bioequivalent metformin.)
How do you cite from the KAR?
Agency (Ag), Article (A), Section (S) Example: If pulling from agency 68
What is the definition for pregnancy category A?
An adequate number of studies in pregnant women have been conducted, which demonstrate no risk to the fetus during any trimester. Drugs within this category should still have a statement to the effect that these studies do not rule out the possibility of harm and should still only be used in pregnancy if necessary.
What is the definition for a device?
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: (1) recognized in the United States Pharmacopeia, National Formulary, or any supplement of them, *and* (2) intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, *and* (3) intended to affect the structure or any function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose. (Note that, unlike drugs, devices are only found in the USP-NF. Devices are not found in the HPUS.)
What is the scope of practice for a veterinarian?
Animals (pretty simple) They can write whatever they want for animals. They can't write anything for humans.
What is the definition of a state?
Any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico (Note that the definition of state includes things that are not states. i.e. DC, Puerto Rico, Guam, etc.)
What is the definition of a territory?
Any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone (Note that under this definition and the definition of states that DC is considered both a territory and a state. Puerto Rico is just considered a state.)
What kinds of places is the DEA allowed to inspect?
Any place where controlled substances are kept
How can someone access the USP-NF?
Anyone enrolled in a college or school of pharmacy can access it by creating an account on the USP website
What is meant when speaking about how false or misleading labeling is considered misbranding?
Anything false or misleading on a label and within labeling will cause a product to be misbranded This broad statement covers many things, including wrong information on a label or within labeling, missing information on a label or within labeling, or added or unapproved information on a label or in labeling. Recall the definition for labeling: it includes things like labels, prescribing information, medication guides, and advertisements, to name a few. This is why companies have to be careful about what they say in advertisements.
What is the scope of practice for a podiatrist?
Anything regarding the feet and ankles (and hands in some states, but we won't worry about that now). A weird case is that they might be able to prescribe a diuretic for edema but not for HTN.
What is the scope of practice for a dentist?
Anything regarding the mouth, jaw, and face area. Nothing else. They might prescribe an opioid for pain after a surgery or antibiotics for an infection, but they can only prescribe for those things if they involve the mouth, jaw, or face.
What book is often used to find equivalency ratings for different products? What is it also known as?
Approved Drug Products with Therapeutic Equivalence Evaluations AKA - The Orange Book
Why would manufacturers choose to continue to make orphan drugs if they are only useful for rare conditions?
Because the manufacturers receive tax benefits for keeping the product available (That's why it's important to define them)
What is the definition for pregnancy category X?
Studies in humans or animals have demonstrated a risk to the fetus, and the risk outweighs any possible benefits of the drug. Statements should be added in the "Contraindications" section of the package insert stating that the drug may cause harm to the fetus if administered while a woman is pregnant. A statement should also be included warning that the patient should be aware of the potential issues with taking the drug while pregnant.
What is the definition for an established name?
The "applicable official name designated pursuant to section 358 of this title; or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium...the common or usual name, if any, of such drug or of such ingredient..." Section 358 referred to in this definition is the section granting authority to designate official names.
What amendment defined and established what qualities make a drug a prescription drug, who can prescribe these drugs, and labeling requirements for these products in addition to allowing both written and oral prescriptions from prescribers, meaning prescribers could now call-in prescriptions over the phone? (It also allowed refills on prescriptions, whereas previously, prescriptions could only be filled once.)
The Durham-Humphrey Amendment of 1951
Where is the Orange Book available online?
The FDA Website (fda.gov) Also comes in PDF, print, and app form
What must be done for the FDA to be able to remove a dietary supplement from market?
The FDA has to prove that the supplement is either unsafe or has false or misleading labeling. The FDA can also remove them for adulteration but must prove that as well.
Which federal act gives the Consumer Product Safety Commission (CPSC) the authority to require special packaging of "hazardous substances" as defined by 15 USC 1261?
The Poison Prevention Packaging Act of 1970 (PPPA)
What information source is like the Orange Book but for biologic products?
The Purple Book
What is meant when speaking about a container composed of deleterious substance?
The container is problematic. The assumption is that if the container is made of a deleterious or dangerous substance, it'll transfer to the drug, and when ingested, the drug can harm someone.
What is the definition for pregnancy category D?
There is evidence of a risk to the human fetus based on investigational experience, marketing experience, or human studies. The potential benefits of using the drug may be acceptable despite the risks to the fetus, and these should be weighed when deciding if the drug should be used over an alternative treatment or no treatment. There should be a statement warning of fetal harm, and the patient should be made aware of the risks.
What process must regulations go through before they become final? What can happen to regulations that don't go through this process?
They must go through a publication and comment process. This is known as promulgation. If they don't go through this process, they can be challenged in court for not following proper procedures
What is meant when speaking about how information not being "prominently displayed" is considered misbranding?
This provision highlights that things must be able to be read and understood by "the ordinary individual under customary conditions of purchase and use."
What is meant when speaking about a drug that has been mixed to reduce quality or substituted?
This provision is about mixing products differently from the labeled directions. This doesn't mean mixing as required by the labeling, but instead purposely mixing differently than required or purposely mixing to reduce the quality of a product. Example - If the label required we use sterile water and ethyl alcohol was used by accident, that would be adulteration. It would also be adulteration if our final concentration should be 5 mg/ml, and we purposely diluted the product to 0.5mg/ml to make it go farther.
What disclaimer must be put on all dietary supplement packaging?
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Note that, according to the DSHE, this statement must be prominently displayed. However, most products don't display it as prominently as you might expect.
Where are most citations for pharmacy or drug-related topics located in the USC and CFR?
Title 21, "Food and Drugs"
How do you cite federal statutes and regulations?
Titles (T), Sections (S), and Subsections (Ss) Example: If citing from the US Code title 21, section 353, and subsection b, it would be written as 21 USC §353(b). If citing from the CFR title 21, section 1306.4, and subsection a, it would be written as 21 CFR §1306.4(a).
T or F: In very general terms, the DSHE made it so that the FDA is forced to treat dietary supplements more like food than medication.
True
T or F: Scope of practice and specialty are NOT the same thing. A doctor who works as an oncologist is able to write a prescription for Adderall for their child.
True A physician can write for anything regardless of their specialty. Note that you can refuse to fill if you want, but it's not illegal for them to write whatever they want.
T or F: A tech counting tablets on a counting tray without cleaning the tray after counting the previous medication can be considered adulteration.
True If residue from the previously counted drug gets on the tablets of the current medication, this drug could be considered both filthy, putrid, or decomposed and packed under unsanitary conditions.
T or F: Regulations often provide detailed information on how to go about following a particular law.
True Laws often don't tell you *how* to follow laws. Regulations usually do that.
T or F: Prescription drugs that were originally manufactured in the US before being exported to another country are not allowed to be re-imported into the US.
True Outside of specific circumstances
T or F: Although the FDA has 180 days to respond to an NDA, they usually take longer than that due to lengthy delays.
True Pretty common due to the nature of scientific information. Manufacturers can technically take the FDA to court over these delays, but many manufacturers realize that a legal battle would not help the situation and may delay the decision as the FDA focuses on preparing for the legal issues. Instead, the manufacturers often opt to assist the FDA in any way they can
True or False: Although used in animals, prescription drugs are only approved for use in humans.
True Read the definition
What is meant when speaking about a drug containing an unsafe coloring agent?
Written to include all unsafe coloring agents when added to a product Note - For adulteration, it's about an unsafe coloring agent. For misbranding, it's about a coloring agent not being included on the label. A drug can be considered both in the right circumstances.
Do package inserts need to come with a product when they're shipped to your pharmacy? Do you need to give them to the patient when dispensing a medication?
Yes, they need to come with the medication when it's shipped to the pharmacy. If it doesn't come, then the medication is considered misbranded. No, you don't need to dispense them to the patient.
What can a DEA inspector inspect at your pharmacy? What are they not allowed to inspect?
Can Inspect: -Records and reports relating to controlled substances -The premises within reasonable limits -An inventory of controlled substances (Can do all this without a warrant) Can Not: -Review financial data, sales data, or pricing data, even when related to controlled substances (Unless given written consent by the owner or pharmacist in charge or pursuant to a warrant)
How do you cite from the KSA?
Chapters (C), Articles (A), Sections (S) Example: If pulling from chapter 65, article 16, and section 37a, it would be cited as KSA 65-1637a.
What kinds of claims are dietary supplements not able to make?
Claims about diseases. Specifically: -Damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension) Note that this does not include things like nutrient deficiencies (eg., scurvy). Supplements can claim to prevent these types of diseases.
What regulations establish minimum requirements for manufacturing, packaging, and holding products?
Current Good Manufacturing Practices (cGMP)
What is the definition for *BTC* drugs?
Drugs available to patients without a prescription after consultation with a pharmacist (Examples include pseudoephedrine and codeine cough syrup)
What is the definition for *OTC* drugs?
Drugs that are safe and effective for use without a prescriber's supervision for certain conditions Actual legal definition - Drugs that are: (a) not subject to section 353(b) of this title; and (b) not subject to approval in an application submitted under section 355 of this title
What is the definition for *orphan* drugs?
Drugs that are used for a condition that: -"Affects less than 200,000 persons in the United States" or -"Affects more than 200,000 persons in the United States *and* for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug."
What is the definition for *controlled* drugs?
Drugs with dependence liability or the potential for abuse
What aspects of drugs can make them considered filthy, putrid, or decomposed?
Expired substances or contaminated substances: -Expired substances in the product -The product itself being expired -Degraded materials -Precipitation in solution -Unclean containers -Contaminants in or on a product -Dropping tablets on the floor (!!!)
T or F: For the time being in this class, we will assume that we can't fill for mid-level practitioners who aren't licensed in Kansas unless they're a nurse practitioner or physician's assistant.
FALSE Assume that we can't fill for ANY mid-level practitioner unless they are licensed in Kansas. (We'll cover this more in depth in a later section.)
T or F: If a prescription was filled at a central fill pharmacy before being dispensed to the patient at a different pharmacy, the name and address of the central fill pharmacy needs to be on the label.
FALSE It only needs the name and address of the dispenser. (It usually has both but only NEEDS the dispenser.)
T or F: The FDA can only inspect pharmacies that manufacturer, prepare, or compound drugs or devices.
FALSE That is the the exemption according to the Food, Drug, and Cosmetic Act, BUT case law has established that the FDA can inspect pharmacies that don't fall under this umbrella to determine if they manufacture drugs and verify compounding is being done appropriately.
T or F: The Orange Book can be used to help determine effective therapeutic substitutions, like replacing doxycycline monohydrate 100mg with doxycycline hyclate 100mg.
FALSE The Orange Book does NOT deal with therapeutic substitution or pharmaceutical alternatives. These aren't pharmaceutical equivalents, so the Orange Book doesn't deal with it.
T or F: Under the DSHE, manufacturers are able to make claims about the effects of their supplements without evidence to support the claim.
FALSE They do need evidence. However, that evidence doesn't have to be shared with the FDA before taking the supplement to market. It just has to be shared within 30 days of marketing the supplement.
T or F: cGMP are regulations that establish the minimum requirements for manufacturers and compounding pharmacies.
FALSE They only set requirements for manufacturers, not for compounding pharmacies. They only affect pharmacies if the pharmacy engages in manufacturing.
What form is the notice of inspection for the FDA? What form is the notice of inspection for the DEA?
FDA - FDA form 482 DEA - DEA form 82
What is the first part of the PDMA? What is the second part?
First - Prohibits a prescription drug's reimportation into the United States unless reimported by the drug manufacturer or for emergency use after FDA review Second - Bans the sale, purchase, or trade or offer to sell, purchase, or trade a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity
How is an NDC broken down?
First Section (usually 5 numbers) - Manufacturer Second (usually 3 numbers) - Product Third (usually 2 numbers) - Package Size
What does GRAS stand for? What does GRAE stand for?
GRAS - Generally Recognized as Safe GRAE - Generally Recognized as Effective
Which types of pharmacies are allowed to have drug samples on their premises?
Hospital and Clinic Pharmacies (Retail pharmacies aren't allowed)
What is an IND? When must it be submitted to the FDA?
IND - Investigational New Drug Application It's the application a company sends to the FDA, asking them for an exemption to the new drug requirements to investigate and conduct clinical trials on a new drug. It must be submitted for each clinical trial phase though the FDA does allow a company to apply for more than one phase in a single application. Note that the IND goes into effect 30 days after submission unless the FDA requests further information from the company.
According to the DSHE, when are manufacturers able to make a claim about the supplement's effect a structure or function of the body?
If the claim: 1. Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States 2. Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans 3. Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function 4. Describes general wellbeing from consumption of a nutrient or dietary ingredient
What is meant when speaking about how inspection refusals are considered adulteration?
If you refuse to allow an inspector into any facility where drugs are handled, everything in the warehouse, factory, or another location is considered adulterated. This is often why pharmaceutical companies have specific entry points and require you to use them. They don't want anyone to open a random door somewhere, and an inspector happens to be there and requests to come in and be denied.
What is the definition of a person?
Includes individual, partnership, corporation, and association (Note that it doesn't always mean just a single individual)
What is an IND application?
Investigational New Drug Application - The application sent to the FDA asking them for an exemption to the NDA requirements to investigate and conduct clinical trials on the new drug
What does the PDMA say about selling drug samples or drug coupons?
It prohibits the sale, purchase, or trade or offer to sell, purchase, or trade a drug sample and prohibits the sale, purchase, trade, and counterfeiting of drug coupons
What age of child is the PPPA meant to protect?
Kids under the age of 5 (i.e. 4 year old and younger)
Are you allowed to prevent the FDA from inspecting your retail pharmacy?
Kind of. If they don't have a warrant, you can refuse them and require them to come back with a warrant. However, doing that can lead to fines and imprisonment. Don't do it.
What is the definition for label? What is the definition for labeling?
Label - Any printed, written, or graphic material on the actual product container (Note that it has to be *on the container*) Labeling - All labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product
What is meant when speaking about how missing certain manufacturer information is considered misbranding?
Labels must list the name and place of the manufacturer, packer, or distributor. Without this information, a drug is misbranded.
What is meant when speaking about how missing quantity information is considered misbranding?
Labels must provide a statement of the quantity of the product in the container. This will vary depending on the product but might list the number of tablets, ounces, weight, or another measure.
What is the definition of a law? Do laws reflect if things are morally or ethically right or wrong?
Law - The body of principles that govern conduct and the observances of which can be enforced in courts (i.e. they tell us what's legal) No, laws don't dictate what is morally or ethically right or wrong.
What is the main difference between laws and regulations?
Laws are put in place by elected officials (i.e. the legislature) Regulations are put in place by administrative agencies (i.e. FDA, DEA, state boards of pharmacy, etc.)
Where are federal regulations listed? How can you find them?
Listed in the Code of Federal Regulations (CFR) Found at ecfr.gov
Where are Kansas regulations listed? How can you find them?
Listed in the Kansas Administrative Regulations (KAR) Found at the Kansas Secretary of State website (sos.ks.gov)
Where are Kansas statutes listed? How can you find them?
Listed in the Kansas Statutes Annotated (KSA) Found at the Kansas Office of Revisor of Statutes website (ksrevisor.org) under the statutes tab
Where are federal statutes listed? How can you find them?
Listed in the United States Code (USC) Found at uscode.house.gov
How often do manufacturers go through an inspection process?
Manufacturers must be registered with the FDA and *generally* go through an inspection process at least once every two years Note - This can be delayed for companies in specific locations due to the difficulty of obtaining visas and traveling internationally.
What aspects of drugs can make them considered prepared, packed, or held under unsanitary conditions?
Manufacturing and storing conditions: -Inappropriate temperatures for an inappropriate period -Inappropriate environment -Repacked under inappropriate conditions -Wasn't tested appropriately -Wasn't prepared following current good manufacturing practices (cGMP) Main Takeaway - A drug is considered adulterated if it's in conditions where it *may* have been contaminated. It doesn't have to actually have been contaminated to be considered adulturated.
If you have a product that is labeled as having an expiration date of May 2022, which day of May is considered the expiration date?
May 31st (If you're only given a month, assume that the last day of the month is the expiration date. If the month was February, it would be the 28th.)
What is an NDA? What information must be included? How long does the FDA have to respond?
NDA - New Drug Application The application submitted to the FDA to approve a drug product for marketing. The NDA must detail all of the information obtained during the IND process, which can often be hundreds of thousands of pages of material. Once the NDA is submitted, the FDA has 180 days to respond to the company with an approval or a complete response letter.
What is an NDA?
New Drug Application - The application sent to the FDA once all clinical trials and data have been collected on a new drug to have the drug approved for marketing
What process must a company go through to bring a new drug to market?
New Drug Approval Process AKA - Drug Registration Process
Can you reuse child-resistant packaging? (Example: Refilling a patient's prescription in their old prescription bottle that they brought in.)
No
Are you allowed to resist state Board of Pharmacy inspections?
No You can't say no to entry, and they can inspect without a warrant.
What is the definition for pregnancy category C?
No adequate studies have been conducted in pregnant women. Animal reproductive studies have been conducted and show potential for fetal risk, or animal reproductive studies have not been conducted. Drugs within this category should contain a statement stating that the drug should only be used if the potential benefits outweigh the potential risks.
What is the definition for pregnancy category B?
No adequate studies in pregnant women have been conducted, but animal reproductive studies have not demonstrated a risk to the fetus. Again a statement should be included noting that these studies do not rule out the possibility of harm and should still only be used in pregnancy if necessary.
Which drugs MUST be dispensed in child-resistant packaging?
None (Kind of a trick question. There are exceptions for when patients don't want child-resistant packaging.)
What USP chapters set standards for nonsterile compounding, sterile compounding, and hazardous drugs?
Nonsterile Compounding - USP 795 Sterile Compounding - USP 797 Hazardous Drugs - USP 800
What is the PDMA? What was it intended to do?
PDMA - The Prescription Drug Marketing Act of 1987 Intended to protect public health, and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples
What are PPIs and MedGuides?
PPIs - Patient package insert; Contains medication information in patient-friendly language; Must be dispensed with the medication (The only drugs requiring PPIs are estrogens and oral contraceptives.) MedGuide - Medication guide; Patient-friendly language that explains issues related to a specific drug or drug class; Must be dispensed with the medication in outpatient settings
What is the definition of special packaging?
Packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. AKA - Child-resistant packaging Note that it's not childPROOF packaging. Just resistant.
What is the definition for special packaging?
Packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. (Some notes - Kids under 5 should struggle with opening it. Adults should not have an issue using the package.)
What are pharmaceutical equivalents? What are therapeutic equivalents?
Pharmaceutical Equivalents - Products with the same active ingredient, same dosage form, and the same strength Therapeutic Equivalents - Pharmaceutical equivalents likely to have the same clinical and safety profile For products to be interchangeable, they must be both pharmaceutical and therapeutic equivalents.
What is the definition for therapeutic equivalents?
Pharmaceutical equivalents likely to have the same clinical and safety profile (This is determined based on the bioequivalence studies submitted with the application for FDA approval)
What is required for practitioners to request drug samples? When can retail pharmacies have drug samples?
Practitioners must request drug samples in writing Retail pharmacies are not allowed to have drug samples at any time
What kinds of medications did the Federal Anti-Tampering Act of 1983 apply to?
Products directly available to a consumer (i.e. OTC - not prescription - medications)
What is meant when speaking about a drug that doesn't meet official standards or isn't required to meet official standards?
Products in the official compendium have standards for strength, purity, and quality, and how a company tests for or ensures a drug meets these items. Those standards must be met by any drug that claims to be the official drug. Note - The purity or quality may be better than required per this section. Another Note - There are exceptions if the difference is plainly stated on the label
What is the definition for pharmaceutical equivalents?
Products with the same active ingredient, same dosage form, and the same strength (Can differ in regards to look, release mechanism, or expiration time)
What are REMS? What federal act introduced them?
REMS - Risk Evaluation and Mitigation Strategies They are used to manage serious risks associated with using a medication. Introduced as part of the Food and Drug Administration Amendments Act (FDAAA) of 2007
What is the RLD?
Reference Listed Drug - The listed drug identified by the FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. In most cases, this is the original brand name product, but there can be more than one RLD, or the RLD can be changed to a common generic
How long can a prescription for an OTC medication be refilled? How many refills are allowed? When does the expiration clock start ticking? (This is for Kansas, not federal law. For this class, we only need to know Kansas law for these things.)
Refilled - 1 year How Many Refills - Unspecified (as many as the prescriber wants to write) Expiration Clock Starts - The date the prescription is issued
How long can a prescription for an Rx medication be refilled? How many refills are allowed? When does the expiration clock start ticking? (This is for Kansas, not federal law. For this class, we only need to know Kansas law for these things.)
Refilled - 1 year How Many Refills - Unspecified (as many as the prescriber wants to write) Expiration Clock Starts - The date the prescription is issued
How long can a prescription for a C-V, C-IV, or C-III medication be refilled? How many refills are allowed? When does the expiration clock start ticking? (This is for Kansas, not federal law. For this class, we only need to know Kansas law for these things.)
Refilled - 6 months How Many Refills - 5 Expiration Clock Starts - The date the prescription is issued
How long can a prescription for a C-II medication be refilled? How many refills are allowed? When does the expiration clock start ticking? (This is for Kansas, not federal law. For this class, we only need to know Kansas law for these things.)
Refilled - 6 months How Many Refills - None Expiration Clock Starts - The date the prescription is issued
What is a regulation? What term is often used as another name for a regulation?
Regulation - A rule having the force of law issued by an administrative agency In some states, also known as rules.