Longitudinal VI Exam 1 Law

What prohibited the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medications, and liquors and based violations on information listed in the product label ONLY?

Pure Food and Drug Act (PFDA) of 1906

What formally established the FDA and gave authority over food, drugs, therapeutic devices, and cosmetics, required FDA registration and prohibited adulteration and misbranding of medications?

Food and Drug Cosmetic Act (FD&C) of 1938

What medication was changed into an elixir without testing for toxicity and was given to patients without a prescription, leading to death in 1937 and, ultimately, the creation of the FD&C Act?

Sulfanilamide

Who is required to register with the FDA?

Drug Manufacturers and Repackagers

What are products made by companies who fail to register with the FDA considered?

Misbranded

Who is NOT required to register with the FDA, except in the case of compounding/dispensing beyond pursuant to a prescription?

Pharmacies

What is defined as drugs sold, dispensed, or distributed in violation of the labeling requirements of the FD&C Act and focuses on labeling?

Misbranding

What is defined as the failure of a drug or device to satisfy FDA purity standards?

Adulteration

What is legally defined by the following 6 ways?

1. Recognized by USP, Homeopathic Pharmacopoiea of the uS, or official NF

2. Intended for use in the diagnosis, cure, mitigation, or prevention of disease in humans or animals

3. A non-food substance intended to affect the structure of any function of the body of humans or other animals

4. Intended to be used as a component of an item falling within any of these categories

5. The intent of the manufacturer or distributer

6. A classification does not have to be exclusive (can also be a cosmetic)

Drug

What product is not treated as a drug, as long as the manufacturer and distributor does not express it to be a drug and promotes the product with "structure function" claims?

cannot make claims that the product can diagnose, cure, mitigate, treat, or prevent any disease or symptoms

Dietary Supplements

What is considered the first federal requirement for a prescription by dividing drugs into two classes: prescription and over-the-counter and is the federal law most likely to be violated by a pharmacist?

aka "Prescription Drug Amendment"

Durham-Humphrey Amendment of 1951

Who has the authority for categorizing drugs into the classes defined by the prescription drug amendment and requires that ALL drugs must have "adequate directions for use"?

FDA

What amendment to the FD&C Act of 1938 requires proof of efficacy and safety by requiring an NDA prior to marketing a new drug and drug manufacturer inspections every 2 years based on good manufacturing guidelines?

Kefauver-Harris Amendment of 1962

What does the abbreviation DESI stand for, which authorizes drugs reviewed between 1938 and 1962?

Drug Efficacy Study Implementation

What does the abbreviation NDA stand for, which typically includes a comprehensive packet of information from ALL human studies, contains the entire history of development, considers efficacy, safety, stability, production and packaging, and is approved/not approved by the FDA?

New Drug Application

What does the abbreviation IND stand for, which includes pre-clinical data, animal studies, and nonclinical tests?

Investigation New Drug Application

What does SNDA stand for, which includes any change in information reviewed in the NDA?

Supplemental NDA

What does ANDA stand for, which includes the application for generic products after patent expiration and must prove PK, bioavailability, and clinical activity similar to the brand product?

Abbreviated NDA

What is defined by a test conducted in vitro, in silica, or in chemico or a non-human in vivo test that occurs before or during the clinical trial phase of a study of safety and efficacy of a drug?

Nonclinical Test

What was passed in 2022 that authorizes the use of specific alternatives to animal testing in preclinical studies -- substitutes requirement for "animal" studies with "nonclinical tests"?

FDA Modernization Act 2.0

What does the abbreviation NDC stand for, which is a unique, 3-segment number used a universal product identifier for human drugs which identifies the manufacturer, drug, and package size?

National Drug Code

What requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution and the use of an NDC?

Drug Listing Act of 1972

Who selects the generic name of a medication by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships and begins considered applications for the names once IND is active and clinical trials have started?

United States Adopted Names Council

What established approval pathways for generic drugs using ANDA, requires generic drug companies to prove their products are bio equivalent to the brand-name and allows testing before the branded patent expires?

aka Hatch-Waxman Amendments

Drug Price Competition and Patent-Term Restoration Act of 1984

For what duration will the first company to submit a successful ANDA have marketing exclusivity for a generic drug?

180 days

How long will an innovator company retain patent exclusivity if they apply for a patent extension of 5 years?

14 years

What prevents the accidental poisoning of children under 5 years of age by requiring the use of child-resistant packaging for ALL prescription and OTC medications unless otherwise requested by the patient or prescriber and is considered misbranding if it is not performed?

Poison Prevention Packaging Act of 1970

Who regulates and enforces the PPPA?

Consumer Products Safety Commission

What amendment requires pre-market approval for medical devices, differentiates medical devices from pharmaceuticals as instruments that do not cause chemical reactions, and classifies devices based on patient risk?

Medical Device Amendments of 1976

What medical device class requires pre-market approval by the FDA?

e.g. pacemakers

Class III

What act makes it a federal crime to tamper or attempt to tamper with a food, drug, cosmetic, or household device or its label and is enforced by the DEA and Department of Agriculture?

Federal Antitampering Act of 1983

What type of medications are required to be packaged in tamper-resistant packaging UNLESS it is a dermatological, dentifrice, insulin, or lozenge product?

OTC

What act was created to encourage increased development of drugs for rare diseases, which is defined as a disease that affects less than 200,000 people in the U.S.?

Orphan Drug Act of 1983

For what duration do manufacturers receive marketing exclusivity according to the Orphan Drug Act?

7 years

What act prohibits reimporation of drugs produced in the U.S. after they have been exposed to other countries, requires wholesalers to be licensed under state law according to federal standards, and bans the sale, trade, or purchase of drug "samples" or "starter doses"?

Prescription Drug Marketing Act of 1987

What are the three requirements of prescription drug marketing which is regulated by the FDA and, therefore, considering misbranding if violated?

Truthful, Fairly balanced, Fully disclosed

What act requires state medicaid provider pharmacists to review Medicaid recipients entire drug profile before filling prescriptions via ProDUR and requires a pharmacist or intern to offer counseling for each new prescription?

Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

What act prohibits dietary supplement manufacturers and distributors from making false claims on labels and prohibits the manufacture or sale of adulterated dietary supplements?

Dietary Supplemental Health Education Act of 1994

What is otherwise known as the controlled substances act and outlines policies for manufacture, importation, possession, use and distribution of certain chemical substances that have potential for abuse, physical dependence, or psychological dependence in addition to providing the legal creation of the Drug Enforcement Administration (DEA)?

Comprehensive Drug Abuse Prevention and Control Act of 1970

How often must DEA registration be renewed?

3 years

How long must records regarding ordering, storage, distribution, and dispensing of controlled substances be stored?

2 years

What DEA form is used for all C-II orders?

Form 222

What DEA form is used in the case of controlled substance loss or theft and must be reported within 24 hours?

Form 106

What duration is required for both the minimum years of citizenship and licensure in Alabama prior to being an ALBOP member AND the length of one term as a member?

5 years

How many ALBOP members are appointed by the governor of Alabama based on a list of nominees from chain, independent, and hospital pharmacies?

3

How many ALBOP members serve in nondesignated positions are elected by ballot?

2

When does ALBOP need to be notified of a change in any of the following:

Owner of facility

Employment

Supervising pharmacist

Pharmacy student's status

10 days

When does ALBOP need to be notified for a request to use an automated dispensing cabinet?

30 days

What is the minimum score obtained on the NAPLEX in order to be qualified for licensure, which assesses candidate's competence to practice as a pharmacist?

75

What is the minimum externship/internship duration required for licensure as a pharmacist?

1500

What is the fee for a new or renewed pharmacist license in Alabama?

$100

What is the fee associated with a duplicate license OR a late penalty fee (applied per month)?

$10

What is the fee for a reciprocity exam and score transfer in Alabama?

$300

What allows you to transfer license to another state as long as you provide documentation that you are licensed to practice pharmacy in another state?

Reciprocity

What duration of continuing education is required *each renewal cycle( as a condition of licensure renewal?

30 hours

What duration of continuing education is required for pharmacists who have only been licensed for one full calendar year for their first renewal cycle?

15 hours

What duration of live continuing education is required each cycle as a condition of pharmacy license renewal?

6 hours

Any pharmacist who allows license to lapse for _________ is required to provide documentation of completion of 15 hours of CE for each lapsed calendar year.

1-5 years

Who determines the required duration of CE for pharmacists who allow their license to lapse for > 5 years?

ALBOP

Pharmacist license expires on December 31st of ____ numbered years.

Even

For what type of specialized training are pharmacists required a minimum of 8 contact hours, including didactic and hands on experience with a written exam in order to complete initial training?

Sterile Compounding

For what type of specialized training are pharmacists required to complete 200 clock hours of formal didactic training and 500 hours of on-the-job training for initial courses and a minimum of 2 hours of CE prior to each recertification?

Nuclear

For what type of specialized training are pharmacists required to complete an 8 hour ALBOP approved certification course with a passing score of ≥ 75, then a minimum of 8 LIVE hours of approved CE for each renewal cycle?

Consultant

For what type of specialized training are pharmacists required to complete an initial 2 hours training program, then a 2 hours training seminar for each renewal cycle or be approved by the school for curriculum hours?

Preceptor

What duration of continuing education is required for pharmacy technician renewal, with 2 hours being live?

6 hours

Pharmacy technician licensure expires on December 31st of ____ years.

Odd

A statement of charges and notice shall be provided within what time frame prior to a hearing date in relation to the consideration of revoking or suspending licensure?

30 days

What is known as an authorized, structured, ongoing review of prescribing, dispensing and use of medication and may be prospective, concurrent, or retrospective?

Drug Utilization Review (DUR)

What technician:pharmacist ratio is allowed if 2 technicians are certified?

4:1

What technician:pharmacist ratio is allowed if 1 technician is certified?

3:1

What technician:pharmacist ratio is allowed if NO technicians are certified?

2:1

What is the maximum number of interns/externs allowed to be supervised be a licensed pharmacist?

3

What can an intern/extern NOT do?

Perform the final check

What is the minimum number of operating hours per week a pharmacy must be open?

20 hours

What is the minimum square footage required for a pharmacy?

240

What is the minimum square footage of unobstructed working space required for one pharmacist?

16

What is the minimum square footage of unobstructed working space for two pharmacists?

24

What is defined as the filling of a new or refilling of a prescription drug order by one pharmacy licensed by ALBOP at the request of another pharmacy licensed by ALBOP for delivery to a patient pursuant to the lawful order of a practitioner?

Central Prescription Filling

What drugs Cannot be filled centrally?

Schedule 1 and 2

How long must a pharmacist be licensed prior to applying to be a preceptor?

2 years

What three providers cannot prescribe a schedule 2 or methadone?

Midwife, PA, NP

What type of provider cannot prescribe a schedule 2 or methadone and is limited to a 96 hour supply of schedule 3 medications?

Optometrist

What is the maximum day supply allowed for controlled weight loss medications?

35 days