What did the Federal Controlled Substances Act do? Why was it implemented? - correct answer Legislators very concerned in the 1960s about legal and
... [Show More] illegal drugs being abused
They were given the opportunity to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient.
What did the Pure Food and Drug Act of 1906 do? - correct answer Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide warnings
What did the Food, Drug, and Cosmetic Act do? (started in 1938) - correct answer Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs
Describe the FDCA - correct answer The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA; also started the labeling requirements; applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be proven safe
If you get in trouble with the board of pharmacy can you get in trouble with the government too? What about the a lawsuit with a patient? - correct answer Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense
What did the Durham-Humphrey Amendment of 1951 do? - correct answer Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication - correct answer Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do? - correct answer Required all drugs to not only be proven safe but also EFFECTIVE
Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during what time period - correct answer 1938-1962; drugs produced before 1938 were just grandfathered in and did not have to prove their efficacy
What did the Orphan Drug Act of 1983 do? - correct answer Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of rare disease or conditions (those conditions that affect < 200,000 Americans)
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? - correct answer Made generic drugs more readily available to the public and at the same time provided incentives for manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved more easily
What did the Prescription Drug Marketing Act of 1987 do? - correct answer Established sales restrictions and recordkeeping requirements for prescription drug samples
Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the hospitals were getting the drugs for a discount then reselling them)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992 - correct answer Drug companies volunteered to pay tax and the money was used to hire more FDA scientist in hopes to speed up NDA reviews; however the price of drugs just went up to cover the fee being paid by the drug manufacturers
What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do? - correct answer Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as food than drugs
Define dietary supplement per the law - correct answer A product that is intended for *ORAL* ingestion, intended to supplement the diet, and contains any one or more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary substance or use by humans to supplement the diet by increasing the total dietary intake and a concentrate, metabolite, constituent, extract or combination of the previous.
All dietary supplements must be claimed as - correct answer A dietary supplement; they CANNOT say they are drugs or anything else on the labeling
Dietary supplement manufacturers may not make these claims - correct answer Disease Claims
Dietary supplement manufacturers may only make these types of claims - correct answer Structure / Function
The label can't say that it will cure or prevent but it can say "will support or maintain"
Dietary Supplements must have this on the labeling - correct answer "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."
Who enforces drug advertising? - correct answer FDA
Who enforces dietary supplement advertising - correct answer FTC
Do dietary supplements have to be safe and/or effective? - correct answer No
How does a dietary supplement get pulled off the market? - correct answer The FDA cannot act until the dietary supplement is proven to be dangerous; the products should not be adulterated or misbranded (passed in 2007); however since little to no testing is conducted on these products it would be difficult to tell if they are adulterated or misbranded
Can you put a bunch of publications regarding how awesome a dietary supplement is on the self with the dietary supplement to get people to purchase the product? - correct answer No; here are the rules:
Dietary supplement publications must be reprinted in their ENTIRETY
You cannot have any information that is FALSE or MISLEADING
Must be present with other publications, if available, to present a balanced view
All publications must be PHYSICALLY SEPARATE from the product
What did the Food and Drug Modernization Act of 1997 do? - correct answer 1) Renewed the Prescription Drug User Fee Act
2) Compounding by pharmacists was finally clarified
3) Manufacturer only has to do 1 clinical trial to supplement their NDA
4) Established inactive OTC ingredients requirement
5) Pharmacists can do nuclear compounding
6) Fast track approval process for drugs used for serious or life-threatening diseases (initial drugs for this were HIV/AIDS medications)
What organization is the primary enforcer of the FDCA? - correct answer FDA
The FDA is a component of what organization? - correct answer DHHS
Is the USP a government agency? - correct answer No, it is an independent agency that sets purity standards
A drug recognized in the USP/NF must meet all standards or it will be considered - correct answer Misbranded or adulterated
What are the 2 major offenses of the FDCA? - correct answer 1) Adulteration
2) Misbranding
These violations are of "strict liability nature", what does that mean? - correct answer Adulteration or misbranding results in violation of the FDCA regardless of the person's knowledge or intentions
Describe a Class I Recall - correct answer Most serious; issued when there is reasonable probability that the product will cause serious, adverse health consequences or death; must contact patients
Describe a Class II Recall - correct answer May result in temporary or medically reversible adverse effects; probability is remote
Describe a Class III Recall - correct answer Not going to hurt anyone; usually technical violations
What are Current Good Manufacturing Practices? - correct answer A set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product. APPLIES TO MANUFACTURERS ONLY.
Do manufacturers have to register with the FDA? - correct answer Yes
How often does the FDA inspect manufacturers? - correct answer Typically every 2 years
Per the FDCA, define the following, starting with "New Drug" - correct answer Any new drug (except animal drug or feed with animal drug) composition of which is such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions has become so recognized but which has not otherwise than in such investigations been used to a material extent or for a material time under such conditions (if change is from QID to BID for same thing, it has to be a new drug. Same with new indication. New drug also applies to patient population)
What is adulteration - correct answer Adulteration: prepared, packed or held in conditions where it may have been contaminated; exposed to a container that may have contaminated it; or manufactured under conditions that do not conform to current GMP (deals with a drug's strength, purity, and quality)
What are adequate DIRECTIONS for use? - correct answer Directions that the layperson must be able to understand; pertains to OTC drugs
What are adequate INFORMATION for use? - correct answer Prescription medications; adequate INFORMATION for use is designed for healthcare professionals; the package insert
The labeling must include the medical indication, effects, and dosage; the route, method, frequency, and duration, of administration; any relevant hazards, contraindications, side effects, and precautions.
What is a New Drug Application (NDA) - correct answer The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following: Is the drug is safe and effective in its proposed use(s), and do the benefits of the drug outweigh the risks? Is the drug's proposed labeling (package insert) appropriate, and what should contain? Are the methods used in manufacturing (Good Manufacturing Practice,GMP) the drug and the controls used to maintain the drug's quality adequate to preserve the drug's identity, strength, quality, and purity?
The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtain
What is an INDA (Investigational New Drug Application) - correct answer The Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. A clinical study also requires an IND if it is intended to support a: New indication, Change in the approved route of administration or dosage level, Change in the approved patient population (pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) ,Significant change in the promotion of an approved drug.
What is an Abbreviated New Drug Application (ANDA) - correct answer An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug. The ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
What is a compassionate use INDA? - correct answer Permission from the FDA to use a drug on a patient, after all other measures have been exhausted, that has not yet been approved and released to the market. Patient is not registered in a drug study.
What is an Orphan Drug? - correct answer Drugs used for diseases with <200,000 occurrences in the U.S. Incentives are offered to companies to develop medications in class (7 years of exclusive marketing and tax credits).
What is an Approved Drug? - correct answer A new drug for which the NDA has been approved by the FDA and is still valid OR as a drug in use prior to effective date of the 1938 FDCA therefore is not subject to the NDA requirements, provided and distributed promoted in accordance with labeling and established use as then existed.
What is an unapproved drug? - correct answer A drug not approved by the FDA or an NDA not approved by the FDA
What is approved use? - correct answer The prescribing and administering of a drug within the limits of the required dosage and route of administration, therapeutic indications, precautions, warnings, and contraindications.
What is another word for unapproved use? - correct answer Off Label
What is a prescription drug - correct answer Drug intended for use by man which, because of its toxicity or potential for harmful effect or the method of 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 a drug. It is limited by an approval to use under professional supervision of a practitioner licensed by law to administer such drug. Must have a written prescription, oral prescription, faxed prescription, or refill to dispense such medications. Dispensing contrary to these provisions is deemed MISBRANDING.
What is an OTC drug? - correct answer Drugs recognized as among experts to be safe and effective for use. Must be manufactured under the FDA's good manufacturing standards and be labeled with directions for the layperson that indicate their safe and effective use.
Compounding vs Manufacturing - correct answer Compounding / Manufacturing
1) Compounding on a particular basis (if compounding ahead of time in large quantities or without prescriptions would be manufacturing)
2) Being compounded for an individual patient prescription (compounding large quantities for office use or other uses would be manufacturing)
3) The geographic area of distribution (large area would be manufacturing)
4) Whether any advertising is being used (may not advertise for compounding)
5) The % of gross income from sales of particular compounded drugs (large % gross income would be more of a manufacturer than a pharmacy)
6) Whether drugs are being offered at wholesale prices
7) If they do not manufacturer, prepare, propagate, compound, or process drugs or devices for sale other that in the regular course of their business dispensing or selling devices at retail would be deemed manufacturing.
Misbranding is the same thing as - correct answer Mislabeling
What is the definition per the FDCA of adulterated drug? - correct answer Filthy, putrid, decomposed product; Packed/held in unsanitary conditions; methods to produce/package do not follow good manufacturing practice; does not meet compounding standards; container is at all exposed to poisonous or deleterious substance; contains unsafe coloring; new animal drug unsafe within the meaning; animal feed with unsafe drug.
What is strict liability / liability without fault? - correct answer The FD&C Act imposes strict liability (liability without fault) on all who are affected by its provisions. (The specific prohibited acts include misbranding and adulteration of drugs.) Criminal intention is not necessary to violate the Act. It is not a defense to claim lack of knowledge or lack of intent to violate the law. (The Act would be unenforceable if these pleas were acceptable.)
What is the safe harbor provision? - correct answer If pharmacies have a guarantee from the supplier that the drug has not been misbranded or adulterated then the pharmacist will not be responsible for a sealed medication bottle.
Per the FDCA, define dietary supplements? - correct answer 1) Product other than tobacco intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid, a dietary substance for use by man to metabolite, constituent, extract, or combination of any ingredient above.
2) A product intended for INGESTION in tablet, capsule, powder, softgel, gelcap, or liquid form; or if not intended for ingestion in such a form is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.
Who decides if a drug has a black box warning? - correct answer FDA
Who decides if a drug is a REMS drug? - correct answer FDA
What are the 5 pregnancy warnings? - correct answer A, B, C, D, and X
Does the presence of a NDC on a label indicated that a drug has been approved by the FDA - correct answer No, the FDA assigns NDC numbers simply for identification purposes
Name 7 instances when a drug would be approved as a new drug - correct answer 1) The drug contains new substance
2) There is a new combination of approved drugs
3) The proportion of ingredients in combination is changed
4) There is a new intended use for the drug
5) The dosage, method, or duration of administration or application is changed
6) New packing materials
7) A new patient population
Describe the process for filing for an INDA - correct answer 1) File for INDA after animal testing for safety
2) If the FDA does not REJECT the INDA within 30 days then you may being human clinical testing
What is the purpose of Phase 1 Clinical Trials? - correct answer To detect adverse events; not determine efficacy
Who is enrolled in Phase 1 Clinical Trials? - correct answer Healthy patients; need written informed consent [Show Less]