Download Pharmacy Law MPJE Exam: Federal Law with actual Questions & Answers/ latest update 2025; 1 and more Exams Pharmacology in PDF only on Docsity!
What did the Federal Controlled Substances Act do? Why was it implemented? ✔✔Legislators very concerned in the 1960s about legal and 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? ✔✔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) ✔✔Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce
Pharmacy Law MPJE Exam: Federal Law
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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 ✔✔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? ✔✔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? ✔✔Established 2 classes of drugs; prescription and OTC Allows refills on prescriptions and oral prescriptions
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? ✔✔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? ✔✔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 ✔✔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? ✔✔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 ✔✔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 ✔✔A dietary supplement; they CANNOT say they are drugs or anything else on the labeling Dietary supplement manufacturers may not make these claims ✔✔Disease Claims
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? ✔✔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? ✔✔1) Renewed the Prescription Drug User Fee Act
- Compounding by pharmacists was finally clarified
- Manufacturer only has to do 1 clinical trial to supplement their NDA
- Established inactive OTC ingredients requirement
- Pharmacists can do nuclear compounding
- 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? ✔✔FDA The FDA is a component of what organization? ✔✔DHHS Is the USP a government agency? ✔✔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 ✔✔Misbranded or adulterated What are the 2 major offenses of the FDCA? ✔✔1) Adulteration
- Misbranding These violations are of "strict liability nature", what does that mean? ✔✔Adulteration or misbranding results in violation of the FDCA regardless of the person's knowledge or intentions
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 ✔✔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? ✔✔Directions that the layperson must be able to understand; pertains to OTC drugs What are adequate INFORMATION for use? ✔✔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) ✔✔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 obtained, the new drug can be legally marketed starting that day in the United States What is an INDA (Investigational New Drug Application) ✔✔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
subject to the NDA requirements, provided and distributed promoted in accordance with labeling and established use as then existed. What is an unapproved drug? ✔✔A drug not approved by the FDA or an NDA not approved by the FDA What is approved use? ✔✔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? ✔✔Off Label What is a prescription drug ✔✔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? ✔✔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 ✔✔Compounding / Manufacturing
- Compounding on a particular basis (if compounding ahead of time in large quantities or without prescriptions would be manufacturing)
- Being compounded for an individual patient prescription (compounding large quantities for office use or other uses would be manufacturing)
- The geographic area of distribution (large area would be manufacturing)
- Whether any advertising is being used (may not advertise for compounding)
- The % of gross income from sales of particular compounded drugs (large % gross income would be more of a manufacturer than a pharmacy)
What is the safe harbor provision? ✔✔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? ✔✔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.
- 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? ✔✔FDA Who decides if a drug is a REMS drug? ✔✔FDA What are the 5 pregnancy warnings? ✔✔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 ✔✔No, the FDA assigns NDC numbers simply for identification purposes Name 7 instances when a drug would be approved as a new drug ✔✔1) The drug contains new substance
- There is a new combination of approved drugs
- The proportion of ingredients in combination is changed
- There is a new intended use for the drug
- The dosage, method, or duration of administration or application is changed
- New packing materials
- A new patient population Describe the process for filing for an INDA ✔✔1) File for INDA after animal testing for safety
- 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? ✔✔To detect adverse events; not determine efficacy
Describe the ANDA ✔✔The ANDA is for generic drug manufacturers
- Proof of safety and efficacy not required
- Only proof of bioequivalence and proof of GMP is needed Do drugs before 1938 need to be proven safe and effective? ✔✔They were grandfathered in and are unapproved drugs unless they went through the process to get an NDA. However, as of 2003; these grandfathered in agents are not to be sold without an NDA and the FDA has been removing these approved drugs from the market. Describe the FDA fast track approval ✔✔The FDA will expedite the review of the drug if it is intended for the treatment of a serious or life-threatening condition and the product has an effect on a clinical endpoint or on a surrogate endpoint likely to predict clinical benefit. Pharmacist have an ethical obligation to report adverse events to ✔✔MedWatch Direct to consumer advertising of drugs must include what? ✔✔List of the most serious and common risks associated with the drug
Drug manufacturers can only give off-label use information to whom? ✔✔Healthcare Professionals PBM Health insurance plans Group health plans Governmental agencies Boards of Pharmacy are limited to do that only which the gives them the authority to do. ✔✔State Legislature Who regulates compounding? ✔✔The FDA has the authority to regulate compounding but they won't unless it crosses the boundary into manufacturing; therefore they let the states regulate compounding Laws made by court decisions are known as ✔✔Common Law What are judicial opinions? ✔✔Decisions of the court
