Exam 1 Flashcards
What is law?
Body of principles that govern conduct and the observance of which can be enforced in courts
What does the law reflect
Society and values present in the majority of individuals
What does the law not reflect
Whether something in morally or ethically right or wrong
Is law the same as a statute?
Yes
What is a statute/law
A written law enacted by the legislature
Where do laws come from
body of elected officials
What do laws not go through
A public comment and revision process
Where are federal laws listed?
United States Code (USC)
Where are Indiana laws found?
Indiana Code (IC)
What is a regulation
A rule having the force of law issued by an administrative agency
What are regulations also called
rules
Where do regulations come from
administrative agencies
Federal administrative agencies for pharmacies
FDA
DEA
Who establishes rule relevant to pharmacy practice within a particular state
Boards of Pharmacy
What do regulations do pertaining to the law
Regulations tend to provide detailed information on how to go about following a particular law
Where are federal codes found?
Code of Federal Regulations (CFR)
Where are Indiana codes found?
Indiana Administrative Code (IAC)
What is §
Symbol abbreviate for the term section
How are regulations cited?
Titles (T), Sections (S), and subsections (Ss)
What is the US Code citation of title 21, section 353, subsection b
21 USC §353(b)
What is the Code of Federal Regulations citation for title 21, section 1306.04, subsection (a)
21 CFR §1306.04(a)
How is the Indiana Code and the Indiana Administrative Code organized?
titles (T), articles (A), chapters (C), and sections (S).
How is the Indiana Code cited?
IC T-A-C-S
How is the Indiana Administrative Code is cited?
T IAC A-C-S
What does Indiana do to add another article, chapter, or section
Add a decimal after the area of law
What is a drug?
(1) an article recognized in the official compendium or any supplement of the official compendium
(2) an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal
(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)
What is the official compendia?
the United States Pharmacopeia (USP), National Formulary (NF), and Homeopathic Pharmacopeia of the United States (HPUS)
What do the official compendia publications do?
Develop and publish standards for drug substances, drug products, excipients, dietary supplements, and homeopathic articles
What is 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 symbol or statement does prescription drugs must have?
Rx only
Prescription only
Caution: federal law prohibits dispensing without prescription
What is considered an OTC drug?
Drugs that are safe and effective for use without a prescriber’s supervision for certain conditions
What is a behind the counter drug
Drugs available to patients without a prescription after consultation with a pharmacist
What is a controlled substance
drug with dependence liability or the potential for abuse
What is an orphan drug
Condition that “affects less than 200,000 persons in the United States” or a condition that “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 a dietary supplement?
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 new drug?
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.
Has a new drug completed the pre-market approval process?
No
What is a pre-‘38 drug
a drug that was introduced before 1938 and was still on the market in 1962
What are pre-‘38 drugs assumed to be?
Safe for use and effective for their indication based on the longevity on the market therefore they were grandfathered in
When is a new drug application set in?
All the clinical trials and data have been collected on a new drug to have the drug approved for marketing
Why is an investigational new drug application sent?
Asking for an exemption to the NDA requirements to investigate and conduct clinical trials on the new drug
When is an abbreviated new drug application used?
used by generic manufacturers to prove bioequivalence and proof of acceptable manufacturing practices and controls
What is the established name
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…
What is the pharmacy label?
The label is any printed, written, or graphic material on the actual product container.
What is labeling?
all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product.
What is 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.
What are pharmaceutical equivalents?
products with the same active ingredient, same dosage form, and the same strength
How can pharmaceutical equivalents be different (4)
Look
Release mechanism
Expiration time
Labeling
What are therapeutic equivalents
pharmaceutical equivalents likely to have the same clinical and safety profile
What is 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
Difference between device and drug
- Device doesn’t use chemical action or doesn’t need to be metabolized by the body to achieve its primary intended purpose
- Device definition does not include the official compendium since there are no homeopathic devices
In the law, what does a person include?
Individual
Partnership
Corporation
Association
What is a state?
any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico
What is 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
What is a drug’s brand name?
Proprietary name given to the drug by the manufacturer
How can there be different brand names for a single drug entity
Differences in dosage form or release mechanisms
When is a drug or device deemed adulterated (8)
- Filthy, putrid, or decomposed
- Prepared, packed, or held under unsanitary conditions
- Not manufactured under current good manufacturing practices
- Container is composed of deleterious substance
- Contains an unsafe coloring agent
- Doesn’t meet official standards or isn’t required to meet official standards
- Mixed to reduce quality of substituted
- Inspection refusals
What are current good manufacturing practices?
Regulations that establish the minimum requirements for manufacturing drug products for administration to humans or animals
What are compounded drugs exempt from and when
cGMP, misbranding, and new drug requirements
Must be for an individual patients, based on the receipt of a valid prescription from a physician or other licensed practitioner, and compounded by a licensed pharmacist or licensed physician
What is a class 1 devices
A device not used for “supporting or sustaining human life or…for a use which is of substantial importance in preventing impairment of human health” and does “not present a potential unreasonable risk of illness or injury
Class 1 device examples
Stethoscope
toothbrush
bandaid
What are class 2 devices
devices that require special controls to assure the safety and effectiveness of the device.9 These special controls include “promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendation, and other appropriate actions
Class 2 device examples
Syringe
Tampon
Condom
what is a class 3 device
These devices are used for “supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or…presents a potential unreasonable risk of illness or injury.
Class 3 device examples
Replacement heart valves
breast implants
soft contact lenses
FDA and recall authority
FDA does not have the authority to require or mandate a manufacturer to recall a drug, which means the manufacturer voluntarily issues all drug recalls even if the FDA has requested a recall.
Class I Recall
issued when “there is reasonable probability that the use of, or exposure to, a violative product will cause serious consequences or death.
Class II Recall
issued in “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class III Recall
least serious recalls and are issued in situations “in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
What is compounding for an outsourcing facility
the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.
What three things did the Durhamn-Humphrey Amendment of 1951 establish
- Define and establish what qualities make a drug a prescription drug
- Allowed both written and oral prescriptions from prescribers
- Allow refills on prescription
Who grants prescribing authority
states and other jurisdictions
4 prescribers that are recognized in all states and jurisdictions
- physicians
- dentists
- podiatrists
- veterinarians
Scope of practice
What a practitioner can do within their practice and is based on their education and professional licensure
Physician scope of practice
Can prescriber whatever they want for whatever issue a person is having
Dentist scope of practice
Medications for mouth and maxillofacial areas, related structures, and conditions affecting these areas
Podiatrist scope of practice
feet, ankles, and related structures
veterinarian scope of practice
Can only prescribe for animals
7 requirements for prescriptions label
- name and address of the dispenser
- Prescription/serial number
- Date of prescription
- Name of prescriber
- Name of patient*
- Any directions for us*
- Any cautionary statements*
Per Indiana law, how many refills are allowed on non-controlled medications for how long
Refillable any number of times up to 1 year from the date written
Per Indiana law, how many refills are allowed on scheduled III, IV, and V medications for how long
No more than 5 times up to 6 months from the date written
Per Indiana law, how many refills are allowed on scheduled II medications for how long
Not refillable but can be filled up to 1 year from the written date
NDC format
manufacturer-drug-package size
Agency
one person authorizes a second person to deal with a third person their behalf
who is the principal
person who delegates authority to an agent
who is the agent
individual completing tasks that require a legal authority to complete and that the individual does not have on their own
what is 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
Five types of drugs that require special packaging
- Controlled substances 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
- Sample packages for medications that generally require special packaging
Nitroglycerin special packaging requirement exemption
sublingual dosage form
Isosorbide dinitrate special packaging requirement exemption
10 mg or less and
sublingual and chewable forms
erythromycin special packaging requirement exemption
ethylsuccinate granules for oral suspension and oral suspensions containing 8g or less of erythromycin, or tablets in package containing no more than the equivalent of 16 grams erythromycin
birth control special packaging requirement exemption
cyclically administered oral contraceptives
conjugated estrogens
norethindrone tablets
cholestryamine special packaging requirement exemption
powder form
potassium special packaging requirement exemption
all unit dose forms of potassium, 50 mEq or less
betamethasone special packaging requirement exemption
packaged in manufacturers’ dispenser packages, containing 12.6 mg or less
prednisone special packaging requirement exemption
when dispensed in packages containing no more than 105mg total
medroxyprogesterone special packaging requirement exemption
tablets
methylprednisolone special packaging requirement exemption
packages containing not more than 84mg total
colestipol special packaging requirement exemption
powder in packages containing no more than 5g total
mebendazole special packaging requirement exemption
tablets in packages containing no more than 600mg total
Are leaflets legally required to be dispensed to patients?
nope
package insert law
package inserts must be with a product when shipped to pharmacy and while sitting on the pharmacy shelf
What drugs require PPIs to be dispensed
estrogens and oral contraceptives
When must MedGuides be provided
On new and refill prescriptions for patients in an outpatient environment because they are not under the direct supervision of a healthcare professional
How can misbranding occur with MedGuides
Failing to dispense a MedGuide when required
What is covered in USP <795>
nonsterile compounding
assigning BUD
What is covered in USP <797>
sterile compounding
What is covered in USP <800>
hazardous drugs
6 criteria to be considered hazardous drugs
- carcinogenicity
- teratogenicity/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
Purpose of PDMA
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
First part of PDMA
prohibits a prescription drug’s reimportation into the US unless reimported by the drug manufacturer or for emergency use after FDA review
Second part of PDMA
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
final part of PDMA
details requirements for wholesale distributors, record keeping requirements, and “whistleblower” awards for turning in someone who is violating the PDMA
record keeping for PDMA
records must be maintained for at least 3 years
can be kept in electronic format as long as they are easily retrievable and resistant to tampering, modification, or unauthorized use
whistileblower award of PDMA
if you provide information on someone violating the PDMA and that information leads to a conviction, you are “entitled to one-half of the criminal fine imposed and collected for such violation, but not more than $125,000
wholesale distributors for PDMA
States must license wholesalers; wholesalers must keep a record of their purchase of a product and provide a statement of origin if they are not an authorized distributor
manufacturers must maintain a list of authorized distributors in their corporate office
Federal Anti-Tampering Act Key Points (2)
- Tamper evident packaging on consumer products act
2. Makes it a federal offense to tamper with consumer products
Tamper-evident design features (5)
- Distinctive by design: cannot be replicated with commonly available materials or processes
- Package must have one or more indicators or barriers to entry that use an identifying characteristic like a trademark, pattern, phrase, or picture
- Remain intact during handling and distribution process from the manufacturer to the retail shelf.
- Any product using a capsule must seal the capsule
- Packages must have a prominently placed statement on the package identifying all the tamper-evident features
Dietary Supplement Health and Education Act key point
FDA is forced to treat dietary supplements more like a type of food instead of a drug
DSHEA allows a manufacturer to make claims relating to a dietary supplement’s effect on a structure or function in the body if the claim falls into any of the four following categories
- Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States
- Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans
- Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function
- Describes general wellbeing from consumption of a nutrient or dietary ingredient
What must all dietary packing contain?
This statement has not been evaluated by the Food and Drug Administration
Do dietary supplements need FDA premarket approval?
No since dietary supplements are treated as foods
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.
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.
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.
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.
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.
Pregnancy category nomenclature change
As of June 30, 2017, the specific pregnancy categories A, B, C, D, and X are no longer used in product labeling for newly approved products. Instead, the labeling has been updated to include three categories – pregnancy, lactation, and females and males of reproductive potential, located in the package insert’s specific populations section
What agencies can perform pharmacy inspections (3)
- FDA
- DEA
- BoP
When are pharmacies not exempt from FDA inspection
pharmacy manufactures, prepares, or compounds drugs or devices
FDA can come in and inspect a pharmacy to determine if the manufacture drugs and now to verify compounding is being done appropriately
FDA inspection form number
FDA form 482
Where can DEA perform inspections?
any place where controlled substances are kept
What DEA form is needed when they request entry for inspection
DEA form 82
what is AIW and when can it be issued
administrative inspection warrant
anything that is considered a valid public interest can lead to one being issues
can only be served during regular business hours
Can you resist a BoP inspection
nope
what provides equivalency ratings for different products
Orange Book
what provides information on interchangeable biological products
purple book
what are A rated products
rated products are bioequivalent to the RLD and are therefore therapeutically equivalent to that product and can substituted
what are B rated products
B-rated drugs are not bioequivalent and therefore are not therapeutically equivalent to the RLD and cannot be substituted
what are AA products
“products in conventional dosage forms not presenting bioequivalence problems
what are BX products
“products for which the data are insufficient to determine therapeutic equivalence
what are AN products
bioequivalent “solutions and powders for aerosolization
How long does the FDA have to respond to the NDA
180 days
What does the drug approval process start with
The company submitting and IND application to the FDA
What is an IND
application a company sends to the FDA, asking them for exemption to the new drug requirements to investigate and conduct clinical trials on a new drug
What is an ANDA
application submitted to the FDA to approve a therapeutically equivalent product already on the market
Who is responsible for developing appropriate strategies for mitigating the risk with the product
the manufacturer
Four different types of REMS
- Patient-friendly labeling like medication guides
- Communication plans for disseminating information to healthcare practitioners about the risks of the drugs and the REMS program in place
- Elements to assume safe use (ETASU), like iPledge
- Implementation ETASU
Pregnancy category change
Pregnancy categories are no longer used in PIs for products approved after June 30, 2017, and all PIs from June 30, 2001, will be updated with the new information. Pregnancy categories may still be used in older product information approved prior to 2001.
