Pharmacy Law: Chapter 2; Abood
Help-Seeking Advertisements
May be sponsored by a manufacturer, but do not contain a drug name i.e. a commercial telling people to get help for depression sponsored by Eli Lilly
Imitation Drug
Misbranding -identical in shape, size, color -similar or virtually identical in gross appearance -similar in effect to controlled substances
P Classification
classified as a priority drug by FDA in NDA process -no other effective drugs available -more effective or safe than drugs available -has important advantages than drugs available
S Classification
classified as a standard drug by FDA in NDA process
Counterfeit Drug
container or labeling bears trademark, trade name, or other identifying mark, imprint, or device or any likeness thereof of a drug manufacturer, processor, packer, or distributor (other than the actual ones) without authorization and thus is falsely representing itself
Dietary Supplement Health and Education Act of 1994 (DSHEA)
defined dietary supplements; permitted manufacturers to make certain claims that otherwise would have been illegal under the FDCA dietary supplements treated more like foods than drugs
label
display of written, printed, or graphic matter upon the immediate container
Biologic
drug derived from living organisms through molecular biology techniques i.e. a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivatives applicable to the prevention, treatment or cure of a disease or condition of human beings.
authorized generic
drug produced by the brand rx company and marketed at generic prices during and after the 180 exclusivity period that is identical to brand alternative in both active and inactive ingredients
Medical Food
food administered under the supervision of a physician and intended for the specific dietary management of a disease for which distinctive nutritional requirements are established; specially formulated -Examples: foods formulated without phenylalanine for phenylketonuria, folic acid + B6 + B12 combo foods for hyperhomocysteinemia
OTC Drug Review (1972)
identified which OTC active ingredients are generally recognized as safe and effective via monograph with 3 categories -Category I: GRSE, not misbranded -Category II: includes products that are not GRSE or that are misbranded -Category III: includes ingredients with insufficient data to permit classification
Drug Competition Action Plan 2017
implemented policy designed to bring complex generic drugs to the market more quickly
Pure Food and Drug Act of 1906
prohibit the interstate transportation/sale of adulterated and misbranded food or drugs
Code of Interactions with Healthcare Professionals (2002)
prohibits companies from providing entertainment and recreational activities to healthcare professionals, either separate or in conjunction with an informational or educational program prohibits providing healthcare professionals with items with minimal value like pens, notepads, mugs that do not advance education
Unit Dose Labeling
-name of drug -qty of active ingredient -lot # -manufacturer -strength per dosage unit -"warning may be habit forming" (where applicable) -controlled drug symbol if CII-CIV or N
Exemptions to the "true statement"
-reminder advertisements -institutional advertisements -Help seeking advertisements without a drug name
National Drug Code (NDC)
Each drug produced by a manufacturer is identified with a 10 digit NDC number. The NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size.
Federal Anti-Tampering Act of 1982
Federal crime to tamper with OTC Required tamper-resistant packaging on selected OTC drug products and cosmetics
cosmetic labeling
-list of ingredients in descending order of prominence -specified warning statements
Manufacturer Bottle Label Requirements
-manufacturer -drug name -quantity -inactive ingredients -"rx only" -route of admin (if not oral) -NDC, lot #, expiration -dispensing container specifications if applicable
Cosmetic
(1) article intended to be ....applied to the human body for cleansing, beautifying ...altering the appearance (2) articles intended for use as a component of any such articles; except that such term shall not include soap. Manufacturer does not have to follow CGMP
Acceptable Scientific & Medical Information Manufacturers can distribute
(1) journal articles (2) reference texts (3) clinical practice guidelines
Nutritional Support Statements
(1) state benefit of classical nutrient deficiency disease (2) describe the role of dietary supplement in affecting structure/function of the body (3) documented mechanism supplement acts to maintain structure or function (4) statements describe general well being from supplement i.e. energizer, relaxant
ANDA Patent Certifications
(I) The NDA holder did not file information on the patent to the FDA (II) The patent already expired (III) The date that the patent will expire (IV) The patent is invalid or will not be infringed by the manufacturer, use, or sale of the generic applicants drug
Drug
(a) recognized by pharmacopoeia (b) articles used for dx, cure, mitigation, tx, or prevention of disease (c) articles other than food intended to affect the structure or function of the body
Medical Device Classification
-Class I: low risk general control i.e. needles, gloves, stethescope -Class II: potential risks regulations i.e. biological indicators, chemical indicators, sterilization equipment -Class III: stringently regulated needs pre-market approval (PMA) from FDA i.e. pacemaker, contact lens,
Durham-Humphrey Amendment of 1951
-Established 2 classes of drugs: Rx and OTC -permitted verbal transmission of rx's -permitted refills on rx's
OTC Labeling Requirements
-Name of the drug -Purpose -Uses -Warnings -Directions ("Adequate directions for use") -Other Information (as required by monograph) -Inactive/active ingredients -Name & address of manufacturer, packager, or distributor -Net quantity of contents - call 1-800... to report adverse effects
Adulteration
-contains filthy, putrid, or decomposed substance -prepared under unsanitary conditions -facility not conforming to CGMP -container contains poisonous substance -unsafe color additive -drug name recognized in USP and its strength differs from, quality/purity falls below set standards -mixed to reduce quality or strength -substituted wholly
Misbranding
-false or misleading label -label lacks name and place of manufacturer -label lacks quantity of contents in terms of wt., measure, count -label lacks required info -label lacks generic name (must be no smaller than 1/2 size of brand) -label lacks inactive ingredient names -label lacks adequate directions for use -label lacks adequate warnings against use in spec. pops -failing to package drugs susceptible to deterioration appropriately -if it is dangerous to heath if used in dosage manner on label -if it is an imitation of another drug -if it is offered for sale under the name of another drug -label lacks brief summary -packaging violates poison prevention act of 1970 -failure to package OTC in tamper evident package
"True Statement" Label Requirement
A drug is misbranded unless the manufacturer includes in all advertisements -established name of the drug -formula, showing quantitatively each ingredient -a "brief summary"
qualified health claim
A health claim that has less scientific backing and must be accompanied by a disclaimer (or qualifier) statement.
Neutraceuticals
Any substance that may be considered food that provides health or medical benefits Examples:genetically engineered foods, cereals, soups that contain such health-related isolates as vitamins, minerals, omega-3 fatty acids
Adequate Provision Requirement
Applicable to broadcast media Manufacturer only need to include "major risks" as opposed to brief summary Manufacturer must make adequate provisions for the dissemination of the labeling i.e. toll-free number, web address, referral to healthcare provider
Park Doctrine
Corporate officers of pharmaceutical companies can be prosecuted for corporate violations of the FDCA even if they had no knowledge of the violations.
Drug Price Competition and Patent Term Restoration Act of 1984
DPC/PTRA; streamlined generic drug approval process via ANDA while giving patent extensions, in certain cases, to innovator drugs
Abbreviated New Drug Application (ANDA)
Different company submits to market generic drug after innovator company patent expires. New drug requires proof of similar pharmacokinetic properties, bioavailability, clinical activity (bioequivalence) and proof of CGMP
Drug Efficacy Study Implementation (DESI)
Drugs marketed from 1938-1962 were reviewed for efficacy after Kefaufer-Harris was passed. Legend drugs were examined individually and OTC's were examined by therapeutic category.
Medical Device User Fee and Modernization Act of 2002
Established user fee requirements for premarket reviews of medical devices; renewed by congress every 5 years
Generic Drug Enforcement Act of 1992
FDA staff accepted bribes from generic drug industry personnel in order to facilitate the approval process of certain generic drug products. FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.
Priority Review
FDA will expedite the review of the drug if it provides significant improvement in safety or efficacy
Fast Track Approval
FDA will expedite the review of the drug if: 1) intended for tx of a serious/life-threatening condition and demonstrates the potential 2) drug has an effect on a clinical endpoint reasonably likely to predict clinical benefit
Accelerated Approval
FDA will expedite the review of the drug if: 1. it provides meaningful advantage over available therapies 2. it demonstrates an effect on a surrogate endpoint reasonably likely to predict clinical benefit
Omnibus Budget Reconciliation Act (OBRA)
Focused on informed decisions by patients rather than decisions by government or healthcare providers on behalf of patients; required pharmacists to provide counseling to Medicaid patients in regards to their medications
Food Additives Amendment of 1958
Food additives require premarket approval for safety
Health Care Economic Information (HCEI)
HCEI provided to formulary decision makers is permissible as long as information is accurate and reliable
Institutional Advertisement
Have only the manufacturer name and area of research but no drug name
New Drug Application (NDA)
If there is sufficient data to demonstrate that a drug is safe and effective, the company submits an NDA as a formal request that the FDA approve it for marketing
Special Dietary Foods
Includes foods that supply a special dietary need that exists by reason of a physical, physiological, pathological, or other condition such as the condition of disease, convalescence (recovery), pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium -Examples: infant formulas, artificial sweeteners, caloric supplements
Phase III Clinical Trial
Large trials (100's-1000's pts), drug is tested for safety and efficacy
Public Health Service Act
Licenses biologic drugs - biologic drugs approved under BLA not NDA - reviewed for purity, potency, and safety
Office of Medical Products and Tobacco
Office of FDA most prevalent to pharmacy practice; center for Drug Evaluation and Research (CDER) responsible for biologics, devices and tobacco products
Phase IV Clinical Trial
Post-market, continue assessing therapeutic value and monitor less common adverse events
Prescription Drug Marketing Act of 1987
Prevents re-importation of a drug into US Prohibited hospital and healthcare entities from reselling their pharmaceuticals;
Class II Recall
Product may cause temporary or medically reversible medical harm but not very likely to cause serious medical harm
Class III Recall
Product not likely to cause medical harm
Food, Drug, and Cosmetic Act of 1938
Prohibits interstate commerce of drugs not shown to be safe for use under the conditions described on the label and approved by the FDA
Lanham Trademark Act
Prohibits the use of any false description or representation Allows for private cause of action and recovery of monetary damages
Food and Drug Amendment Act of 2007 (FDAAA)
Provided FDA with new funding and significantly more authority over drug safety Allows the FDA broader use of the PDUFA fees Increased PDUFA fees Permitted REMS implication by FDA Mandated MedWatch number to be dispensed with all rx's
Orphan Drug Act of 1983
Provided tax and exclusive licensing incentives for the development of orphan drugs for treatment of rare diseases (<200,000 americans)
Color Additive Amendments of 1960
Required manufacturers to establish the safety of color additives in food drugs and cosmetics.
Nutrition Labeling and Education Act (1990)
Required nutritional labeling of almost all foods covered by the FDA with a specific layout Allowed health or disease-prevention claims if there is "significant scientific agreement"
Poison Prevention Packaging Act of 1970
Requires use of child-resistant containers for prescription and nonprescription drugs
Phase II Clinical Trials
Small trial in patients with disease, purpose is to determine efficacy of the drug and at what dosages
Phase I Clinical Trial
Small trials with healthy subjects, purpose is to determine safety and detect adverse effects
Cures Act (2016)
Streamlined drug approval process; added flexibility
Drug Quality and Security Act of 2013 (DQSA)
Strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities. Outsourcing facilities must follow CGMP and may register with FDA
Supplemental NDA (sNDA)
Submitted by manufacturers to FDA for changes in production, labeling or minor changes
Drug Supply Chain Security Act (DSCSA)
Title II of DQSA; added "track and trace" requirements for all entities in the chain of distribution of pharmaceutical products
Bad Ad Program
Truthful Prescription Drug Advertising and Promotion; A way for healthcare providers to report misleading promotional activities to the FDA
Paper NDA Process
Under this policy a generic manufacturer would not have to duplicate the actual research establishing safety and efficacy of the innovator drug, evidence based on published scientific data is sufficient
unqualified health claim
a claim that can stand alone without further explanation or qualification
New Drug
a drug not generally recognized by as safe or effective; not approved by FDA yet
dietary supplement
a non-food form of one or more nutrients vitamin, mineral, herb/botanical
Professional Labeling
additional labeling of OTC intended for healthcare providers, not the consumer
labeling
all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article
Right-to-Try Laws
allows a patient to go directly to the drug manufacturer and bypass the FDA for an investigational new drug; the manufacturer is not obligated to provide the drug
505(b)(2)
alternate NDA established by PTRA; the manufacturer is permitted to rely on published safety and efficacy data findings from a previously approved drug (reduces # clinical trials required)
Purple Book
lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act
Physician Payment Sunshine Act (2010)
mandates disclosure by drug and device manufacturers to the DHHS of nontrivial payments to physicians and teaching hospitals; reportable payments include entertainment, gifts, meals, travel, consulting frees, speaking fees, and certain research funding
USP-NF
official compendium for drug standards in the US
Expanded Access Program
permits patients with life-threatening diseases or conditions who have exhausted approved treatment options to seek access (through physician) to experimental drugs even in phase I clinical trials
FDA Safety and Innovation Act of 2012
reauthorized PDUFA added new user fees for generic drugs and biosimilars increased FDA resources to speed generic approval
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
requires manufacturers of dietary supplements and nonprescription drugs to warn of adverse effects
Prescription Drug User Fee Act of 1992 (PDUFA)
requires manufacturers seeking NDAs to pay fees for applications when the FDA must review clinical studies; reauthorized every 5 years
structure/function claims
statements that characterize the relationship between a nutrient or other substance in a food and its role in the body "calcium builds strong bones" "fiber maintains bowel regularity" "antioxidants maintain cell integrity"
Class I Recall
there is a reasonable possibility that the use/exposure to a product will cause serious adverse effects or death
Reminder Advertisements
used to reinforce previous knowledge of a product i.e. pens, sticky notes *Not permitted for drugs with BBW's
Kefauver-Harris Amendment of 1962
• Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects (FTC -> FDA) • Established GMP
Food and Drug Modernization Act of 1997 (FDAMA)
• passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs • expanded FDA authority over OTC drugs; established ingredient labeling requirements -allowed investigational drugs to be used for patients with immediately life-threatening disease with no alternative therapy available under certain conditions
