Pharmacy Law - Exam 1
Unintentional torts are considered *Negligence* What are "Act of Omission" and "Act of Commission"?
"Act of Omission" = failing to do something a reasonable person would do "Act of Commission" = doing something a reasonable and prudent person would not do.
What are "actus reus" and "mens reus"?
"actus reus" = "guilty act" (action) "mens reus" = "guilty mind" (intent)
What is considered the "unofficial" fourth branch of the government?
*Administrative Agencies* these have the authority to "make" laws
The FDCA establishes two major offenses with regard to drug label and labelling. What are these two offenses and what type of liability is this?
*Adulteration* *Misbranding* these violations are considered to be strict liability offenses (guilty regardless of the person's intentions or knowledge)
Within the FDA, what two committees are most significant to the field of pharmacy?
*CDER* - Center for Drug Evaluation and Research *CBER* - Center for Biologics Evaluation and Research
When did "direct regulation" of the drug industry by the government begin - with what act?
*Direct regulation* began with the Federal Food Drug and Cosmetic Act (1938)
Equal Protection - protection of fundamental rights - what is Enumerated and Unenumerated?
*Enumerated* means it is specifically stated in the constitution (speech, press, vote, etc) *Unenumerated* means it is read into the constitution (privacy, marriage, etc.)
What government entity regulates OTC advertising by manufacturers? What division is the nation's enforcer of this?
*Federal Trade Commission* - The FTC regulates OTC advertising by manufacturers The *Bureau of Consumer Protection* - The Division of Advertising Practices - is the nation's enforcer of federal truth-in-advertising laws.
Executive Branch: President Cabinet Executive Agencies Which two cabinets apply to pharmacy? What agencies are associated with each?
*Health and Human Services (HHS)* - FDA - CMS *Dept of Justice Attorney General* - DEA
What is *information asymmetry*?
*Information Asymmetry* is when the consumer is uninformed about the true value of the good.
Contract Law - what two components define *Mutual Assent*?
*Mutual Assent* = a valid *OFFER* and *ACCEPTANCE*
What is an example of an externality in the healthcare industry?
*Overuse of antibiotics* an *externality* occurs when the production/consumption of a good affects someone who does not fully consent to the effect (ie indirect effects of the drug beyond the consumer/patient)
Laws provide a framework within society. They are made *prescriptively* and *proscriptively*. What do each of these terms mean?
*Prescriptively* - command conduct which must be done *Proscriptively* - command conduct which must NOT be done
The Anti Kickback Statute involves Remuneration and Intent - elaborate on these two concepts what type of liability?
*Remuneration* - kickback, bribe, rebate, cash, anything of value *Intent* - knowingly and willfully *criminal liability*
Define *Statutory Law* and give the hierarchal order of statutory law
*Statutory Law* is law made by legislatures (elected body of persons with primary responsibility to enact laws (statutes). Federal Statutes State Constitutions State Legislation Ordinances
What is the name of the clause that states that federal law is above state law?
*The Supremacy Clause*
What is a *writ of certiorari*?
*Writ of certiorari* is issued by the Supreme Court (SCOTUS) and it "commands" the lower court to bring the appeal to the Supreme Court
While pharmacists must comply with the law, we must also treat patients with _______________________ and _____________________
*empathy* and *compassion*
Administrative Agencies: - What branch of government are these a part of? - Authority? - Examples of these?
- Administrative Agencies are part of the Executive Branch. However, they are also considered *QUASI-LEGISLATIVE QUASI-JUDICIAL* - Administrative Agencies have the authority to administer an area of substantive law. - Examples: CMS, FDA, DEA, FBI, etc...
What did the *Drug Quality and Security Act of 2013* do?
- Defined compounders as "traditional compounder" or "manufacturer compounder" - Provided substantial details regarding oversight, including registration and training requirements - Formalized authority of FDA to inspect compounding facilities
Stages of a lawsuit - just read through these!
- Forum (court) selection - Parties (who is who) - Complaint and summons - Answer - Counterclaim - Cross-claim - Motion to dismiss - Discovery - Motions (ex Motion for summary judgment) - Alternative dispute resolution (mediation, arbitration) - Trial - Appeal
What does DEA Form 82 do?
- Notice of Inspection by consent - inspection by administrative warrant
What two things are considered *public goods* in the drug industry?
- Orphan drugs - Vaccines
What did the Food, Drug, and Cosmetic Act of 1938 do? What spawned the passing of this bill?
- Prohibited marketing of a new drug until proven *safe for use* - required labels to contain *adequate directions for use* - Passed after the sulfanilamide elixir tragedy (where children's medicine had diethylene glycol)
What did the Omnibus Budget Recon Act (OBRA) of 1990 do? 3 major areas
- Rebates - best price for medicaid - Demonstration Projects - DUR (Drug Use Review) and Counseling Standards
What did the two Federal Antitrust Laws do? - Sherman Antitrust Act - Robinson-Patman Act
- Sherman Antitrust (1890 very old) - makes unlawful every contract, combination, or conspiracy that restrains trade - Robinson-Patman (1936 old) - unlawful for sellers to discriminate price between multiple purchasers unless costs can be justified (volume purchases)
What are some of the exemptions from registration for registration requirement of DEA form 224 and 225?
- agent (employee) of registered manufacturer - distributor - common or contract carrier of warehouse - ultimate user who lawfully possesses
How do some states go about dispensing CV as an OTC?
- dispensed only by RPh - must ensure medical necessity - must be 18 years old - must maintain bound logbook
What is a prescription drug?
- habit-forming - not safe for use except under the supervision of a practitioner - articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals - articles (other than food) intended to affect the structure or any function of the body of man or other animals
What does DEA Form 41 do?
- inventory of drugs surrendered for disposal - applies to all CS schedules - blanket authorization for destruction - breakage/spillage
CII for Chronic pain or detox? two issues
- may administer CII for chronic pain - to dispense for detox, prescriber must have a separate registration with DEA as a narcotic treatment program (NTP)
For ordering CIII - CV: is a special form required? how long maintain receipt record?
- no special form required - must maintain receipt record for two years - invoice or packing slip will suffice
What did Kefauver-Harirs Amendment of 1962 do? What was this created in response to?
- required that drugs must be *SAFE* and *EFFECTIVE* - established Good Manufacturing Practice (GMP) - created Med Watch program for reporting of ADR's This was created in response to thalidomide disaster (drug for pregnant women that led to birth defects)
What are the four basic elements that must be proven to obtain a verdict? Which is hardest to prove?
1. *Duty of Care* - obligation to conform to a specific standard of conduct (standard of care) 2. *Breach of Duty* - deviation from standard of care 3. *Injury* - actual damages 4. *Causation* - deviation from standard of care must because of injury - foreseeable *Causation is most difficult to prove*
What are the two elements of Due Process?
1. *Notice* 2. *Opportunity to a hearing*
Three different branches of law - list them. Which one pertains the most to pharmacy?
1. Administrative Law - Regulates professions and industries - *MOST IMPORTANT TO PHARMACY* 2. Civil Law - defines relationships among individuals in society 3. Criminal Law - defines limitations on the relationship between individual and society
What are the 3 main federal healthcare statutes with regard to fraud and abuse)?
1. Anti Kickback Statute 2. False Claims Act 3. Stark Statutes
When can a CII be received via fax? 3 situations
1. CII narcotic compounded for direct admin to pt, by parenteral, IV, IM, SQ, intraspinal admin 2. CII for resident in LTCF 3. CII for pt enrolled in hospice certified by Medicare or licensed by the state, Rx must note that patient is a hospice patient
How does a drug switch from prescription to OTC?
1. Manufacturer may request switch with supplemental NDA 2. Manufacturer (or other organizations) may petition FDA 3. FDA may add or amend an OTC monograph
What are the steps of the Rule Making Process for Administrative Agencies?
1. Notice - placing proposed rules in Federal Register or State Bulletin 2. Opportunity to be heard - Public hearing 3. Publication of final rule (Federal Register, Code of Federal Regulations (CFR), or Utah Bulletin)
What did the *Drug Marketing Act of 1987* do?
1. Regulation of Prescription drug samples 2. Purchases and Releases by Hospital and Health Care entities.
Legal analysis - what are the three different levels of legal scrutiny of fundamental rights analysis?
1. Strict Scrutiny 2. Intermediate Scrutiny 3. Rational-basis Test
The Durham-Humphrey Amendment - What did the law do - three things? Define this distinction.
1. The law created the *distinction between prescription (legend) drugs and OTC drugs* by exempting certain drugs from certain labeling requirements -*OTC drugs* - safe for use without medical supervision because they were equipped with "adequate directions for use" -*Prescription drugs* - unsafe without medical supervision. Have legend "Rx only" and "Caution: Federal law prohibits dispensing without a prescription" 2. Defined rules for dispensing written, oral and electronic prescriptions 3. Labeling requirements - initials/name/license # of RPh, expiration of drug, drug name and strength, patient address, name of manufacturer, lot number
What are some of the permissible claims that a dietary supplement can make?
1. claims a benefit related to a classical nutrient deficiency disease 2. describes the role of a nutrient intended to affect the structure or functions of the body 3. describes general well-being from consumption of a nutrient
What are the three fundamental tenets to a valid CS prescription?
1. issued for legitimate medical purpose 2. prescribed acting in usual course of professional practice 3. pharmacist has corresponding responsibility for Rx validity
Examples of "for profit" business organizations - list
1. sole proprietorship 2. LLC 3. C-Corp 4. S-Corp 5. Partnerships
What is DEA 224 for? frequency? What is DEA 225 for? frequency?
224 - Dispensers (Pharmacies and RPh) - every 3 years 225 - Manufacturers and Distributors - every 1 year
How many states "allow" medical marijuana?
28 states and DC
At any point, a pharmacy may have _____ DEA 222 forms?
42
How many recreational use state of marijuana?
8 Alaska California Colorado Massachusetts Nevada Oregon Washington DC
What is a biological product?
A *biological product* means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product... etc
What is a Federal Statute? What is the acronym used for these?
A Federal Statute is enacted by congress and execute by the executive branch *USC* = United States Code Law = Code = Statute Ex: Pure Food and Drug Act, FDCA, Harrison Narcotic Act, etc...
A Dietary Supplement is defined as a product intended for ______________ (how do you get it in the body)
A dietary supplement is a product intended for *ingestion*
Drug advertising is required to present a *fair balance* on the advertising from the manufacturer to professionals - what does this mean?
A fair balance: - presents a fair balance of information relating to side effects and contraindications and information relating to effectiveness of the drug. - true information relating to side effects and contraindications of the drug.
What is the difference between the AKS and False Claims Act?
AKS is criminal statute CMPL(Civil Monetary Penalty Law) is a civil statute False Claims Act is a civil statute AKS - "knowingly and willfully" False Claims Act - knowledge, ignorance, reckless disregard
Adulteration is focused on the _____________ and ____________ of goods
Adulteration is focused on the *manufacture* and *storage* of goods
What does CGMP ensure?
CGMP = Current Good Manufacturing Practice ensures that a drug is safe and meets the quality and purity reuqiurements
Examples of the scheduled CS for reference: CI CII CIII CIV CV
CI - Heroin, MDA, MDMA, LSD, meth, mary jane, THC, GHB, peyote CII - cocaine, amphetamine, fent, hydromorphone, morphine, codeine, methadone, oxy, pentobarb, hydrocodone combos CIII - ketamine, dronabinol, anabolic steroids CIV - benzos, sleep aids CV - codeine, opium, diphenoxylate
Rx refills and expiration: CII CIII CIV CV
CII - refer to state laws, 0 RF CIII - 6 months, 5 RF CIV - 6 months, 5 RF CV - 12 months, PRN RF
Medical Devices have different classes - Class I Class II Class III What is an example of each?
Class I - toothbrush Class II - insulin pump, thermometer Class III - catheters, pacemakers, (life-supporting)
What clause gives Congress the power to regulate *interstate* commerce?
Commerce Clause this affects the movement of medicinal drugs and medical devices across state lines
What is *common law*? What is the latin term associated with referring to common law?
Common law is law made by the courts From a case the judges record their decisions which then forms a body of law that can be used as a precedent. *Stare Decisis* = "to abide by decided cases"
What did the Durham-Humphrey Amendment of 1951 do?
Created two classes of drugs - prescription and OTC also authorized oral prescriptions and refills other the phone
DEA 222 form - what is its use? Who keeps copy 1,2,3?
DEA 222 Form - for ordering CS Copy 1 - to the supplier Copy 2 - to the supplier, forwarded to DEA Copy 3 - for "requestor", retain with CII records for 2 years *last line must be completed by purchaser, not supplier*
What does DEA form 106 do?
DEA form 106 if for reporting theft or significant loss - must notify DEA/police within 1 business day of discovery of theft or loss - form applies to all CS schedules
What is DESI (Part of the Kefauver-Harris Amendments of 1962)?
DESI = Drug Efficacy Study Implementation - assessed several thousand drugs approved between 1938 and 1962 to determine efficacy for indicated uses.
In Utah, DOPL and the Board of Pharmacy fall under which state branch?
DOPL and BOP fall under the Executive Branch. DOPL is responsible for overseeing professional licensing and regulation
What Amendment was passed in response to the New England compounding tragedy?
DQSA = Drug Quality and Security Act of 2013 - provided more regulatory definitions of compounding activities and expanded FDA oversight and enforcement capabilities for these activiities
What is DSHEA?
DSHEA = Dietary Supplement Health and Education Act of 1994 - provided a hybrid definition of dietary supplements (neither food nor drug) defined/set restrictions for how supplement companies can market their products
Does the DEA require an electronic alarm system for pharmacies?
Does not require, but strongly recommends
What Act allowed manufacturers to obtain approval for generic drugs to obtain approval based on bioequivalence and bioavailability studies? The first generic drug company to market a drug has a ________ day exclusivity period
Drug Competition and Patent Term Restoration Act (PTRA) (aka Hatch-Waxman Act) 1984 The first generic drug company to market a drug has a *180* day exclusivity period
What is a Narrow Therapeutic Index drug?
Drugs where there is less than a two-fold difference between the median lethal dose and the median effective dose or less than a two-fold difference between the minimum toxic concentration and the minimum effective concentration in the blood.
Road to New Drug - what happens first?
IND - Investigational New Drug Application Clinical Trials (Phase I, Phase II, Phase III)
What did the Pure Food and Drug Act of 1906 do?
It prohibited adulterated and misbranded food and drugs *This was the first attempt to regulate drugs
What is the difference between *label* and *labeling*?
Label - a display of written, printed, or graphic matter *upon immediate container* Labeling - all labels and other written material *either upon container or accompanying an article*
What patients are covered under Medicaid? What act is this a part of (think broadly)?
Medicaid: - blind - disabled - aged - members of families with dependent children determined by *income and assets* Created by Social Security Act
What types of patients does Medicare cover? What act brought about its existence (think broadly)?
Medicare provides federal health insurance for: - 65+ - permanent disability - End stage renal disease - exposed to environmental health hazards *Social Security Act created Medicare*
What is NATA and what is DATA?
NATA = Narcotic Addiction Treatment Act - addition treatment programs must register with DEA DATA = Drug Addiction Treatment Act - individual practitioners that want to use CIII-V approved for addiction treatment must request waiver from CSAT
New Drug Application - what does it contain and how long dose the FDA have to review it?
NDA - contains all of the information that the manufacturer has acquired during its investigations FDA has 180 days (6 months) to review the NDA
What is the NDC number used for?
NDC = National Drug Code Number - intended to facilitate automated processing of drug data by government agencies, drug manufacturers, wholesalers, private insurers, etc. identifies: - drug manufacturer/distributor - drug name - package size
Are wine, spirits, beer, tobacco etc considered controlled substances?
NO! These are not considered controlled substances
Is medical marijuana legal?
No, it is "tolerated" - there needs to be more research
Is intent a requirement for Stark?
No, no intent is required
Can prescriptions drugs be reimported to the US?
No, prescription drugs cannot be reimported in the Us
What was PDUFA?
PDUFA = Prescription Drug User Fee Act of 1992 - required additional fees on pharmaceutical manufacturers for NDA
What is a power of attorney with regard to DEA 222?
POA - form must be similar or exactly like the form provided by DEA - does not need to be filed with DEA must be kept - can be revoked at any time - two witnesses on each form
What do the different parts of Medicare do? Part A Part B Part C Part D
Part A - Hospitalization insurance Part B - Outpatient care, DME Part C - Combo of A and B Part D - Prescription Drug Benefit
What do Stark I and Stark II Acts do? what type of liability is this?
Prohibit physicians with financial interest with a provider from making referrals of medicare/medicaid patients to the provider for designated health services to receive payments this is *strict liability*
What is Project HEAT?
Project HEAT is the *Healthcare fraud prevention Enforcement Action Team* Attorney General and HHS
What are Regulatory Safe Harbors with regard to the AKS?
Regulatory Safe Harbors are considered specific safe harbors for various payment and business practices that while potentially prohibited by the law, would not be prosecuted. Example: investment interest, space rental, equipment rental, warranties, discounts, group purchasing organizations, waiver of beneficiary coinsurance and deductible amounts
Patient Package Inserts - the FDA requires PPI for what types of products?
Requires PPIS for *certain hormonal products* - oral contraceptives - oral postcoital contraceptives - injectable contraceptives - estrogens - progestational drug products *the labeling must be given with each package dispensed*
What does the office of the inspector general do? (OIG)
The *OIG* oversees the efficiency of Federal Health Care Programs - Audits and Investigations
Who has the authority to place a drug on the CS schedule? How does this normally occur?
The *US Attorney General (AG)* has the authority to place a drug on a schedule The AG may act in case of immediate need to classify an agent. this happens *in consultation with the Dept of HHS*
The CSA is designed as a ____________ system? Congressional intent is to prevent ___________________ of CS into illegal channels
The CSA is designed as a *closed* system - goal is to be able to trace a CS from the time it is manufactured to the time it is dispensed to the ultimate user. Congressional intent is to prevent *diversion* of CS into illegal channels
What does the *Corresponding Responsibility Doctrine* serve for?
The Corresponding Responsibility Doctrine serves as an important check and balance - Pharmacists should promote responsible access to these therapies without deterring patient from seeking legitimate relief for their conditions - pharmacists should assist patients in obtaining appropriate pain relief, but should be vigilant for system abuse.
What department does the DEA fall under?
The DEA is within the *Department of Justice*
What act created the generic drug industry?
The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman)
What is "corporate officer liability"?
The FDCA imposes criminal penalties on corporate officers even if they do not have personal knowledge of violations ( criminal strict liability) (does not require mens rea)
Federal courts are courts of "limited jurisdiction" - what does this mean? What are two areas where the federal courts have subject matter jurisdiction?
The Federal Court must have jurisdiction over the parties, and the jurisdiction over the type of claim that is the legal issue. Subject matter jurisdiction of federal courts - Federal Question - Diversity Jurisdiction
What Act prohibits false advertising/representations and creates trademark rights?
The Lanham Trademark Act
What is *THE ORANGE BOOK*?
The Orange Book is a resource that states whether a drug product is a therapeutic equivalent. Pharmacists are responsible for ensuring that the substituted generic product is bioequivalent to the prescribed product.
The US constitution is referred to as the "__________________________." The constitution also creates three branches of government - what is the name for this and what are the three branches?
The constitution is referred to as the "*supreme law of the land*" The constitution creates three branches of government - *Tripartite* Branches: 1. Legislative - makes laws 2. Executive - enforces laws 3. Judicial - interprets laws
What was the intent of the "Prescription Drug Marketing Act"?
The intent was to be a *Drug Pedigree Act* - to provide integrity to the supply chain - to reduce public health risks from adulterate and misbranded drugs - prohibited reimportation - directed FDA to develop strategies against counterfeiting of medications *chain of custody of medications*
The law attempts simultaneously to be ____________ and also maintain a reasonable degree of ____________.
The law attempts simultaneously to be *flexible* and also maintain a reasonable degree of *certainty*
What is "Intermediate Scrutiny"?
The law is unconstitutional, unless substantially related to an important governmental interest
The mission of the DEA is to prevent _____________________ and _____________________
The mission of the DEA is to prevent *diversion* and *abuse* of controlled substances and ensure adequate and uninterrupted supply of CS to meet legitimate medical, scientific and research needs.
Who is the package insert intended for?
The package insert is intended for the *learned intermediary* to have sufficient information to use the drug safely and effectively for individual patients.
With regard to the Civil Monetary Penalty Law of the AKS, what does this do?
This establishes penalties for violation of AKS - $50,000 penalty for each violation or *exclusion* - exclusion is especially bad because then you cannot service CMS patients
What does form DEA 223 do?
This form is for *change of address of registrant* - physical change or postal address change requires new registration - must notify DEA 14 days prior to transfer
What does DEA 222 do?
This is for "disposal" of CS - transfer of CS to another registrant - must be kept *two years* - receiving registrant must issue DEA 222 to supplying registrant - cannot be more than 5% of CS dispensed per year - transfer to manufacturer - transfer to reverse distributor
What did the Poison Prevention Packaging Act do?
This required that "household substances" to be packaged for the consumer to use "child-resistant containers" - There are certain exemptions such as for anti-anginal drugs, selected OTC products, and by endorsed patient waivers
True or False - A pharmacist is responsible for knowing which drug products have been recalled.
True. Pharmacists are responsible for knowing which drug products have been recalled - pharmacists may be subject to civil liability in the event of a patient injury following dispensing of a recalled drug
What is the USP? What is HPUS? What is NF?
USP = United States Pharmacopoeia HPUS = Homeopathic Pharmacopoeia of the US NF = National Formulary
Are Robberies/Burglaries considered federal crimes?
YES - if replacement of cost of stolen goods > $500 - person killed or suffered significant bodily injury - $25K fine, 20 years in prison - if gun $35K fine, 25 years in prison - if death $50K fine, life imprisonment
Are there exceptions to Stark?
Yes! Quite a few - prepaid health plans, group practice, ancillary services, etc. considered an "exceptions bill" - it sweepingly prohibits self-referrals but then legitimizes a large number of specific arrangements.
What are *adequate directions for use*?
directions under which a layperson can use a drug safely and for the purpose of which it was intended (OTC label)
Define *New Drug*
drug is not generally recognized among experts as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof
If a prescription is created, signed, transmitted, and received electronically, how should the record be retained?
electronically
How long must CS records be kept?
for *two years* records must be readily retrievable
What are the inventory requirements: should it be done initially? how many times after that? do records need to be submitted to DEA?
inventory requirements: - schedule II (physical count), schedule III-V (estimated), newly schedule Initial inventory is required Biennial inventory thereafter (every 2 years following initial inventory) records do not need to be submitted to DEA - keep with CS records
Multiple CII Rx practice - how many day supply?
may issue multiple Rx for up to *90* day supply - must indicate earliest date on which Rx can be filled
Oral emergency Rx for CII - Emergency Dispensing rules? three factors? day supply for Utah? written Rx must be received witihin
must be immediately reduced to writing by RPh, must include all info three factors: - immediate admin is necessary and proper - no appropriate alternative available - not reasonably possible to provide written Rx 3 day supply in Utah written Rx must be received by pharmacy within 7 days, must include "Authorization for Emergency Dispensing", if not received, RPh is obligated to report to DEA
How many times may CIII-CV Rx's be transferred?
once
Partial dispensing for LTCF - how long Rx valid?
patients in LTFC or documented "terminal illness" may receive partial fillings Rx shall be valid for up to 60 days from issuance
What is the intent of the CS ordering system?
the CS Ordering system will ultimately completely replace 222 forms - also can be used to order CI-CV CS
What is the "5% rule"
the pharmacy may distribute controlled substances to prescribers or other pharmacies without being registered as distributor as long as *total number of dosage units distributed by pharmacy does not exceed 5% of all CS dispensed by the pharmacy during a calendar year*
What are *Scheduled Listed Chemical Products* (SLCP)? List I? List II?
these are products that contain ephedrine, pseudoephedrine, or phenylpropanolamine, and may be distributed lawfully in the US as a non-Rx drug List I - important in manufacture of CS (includes ephedrine and pseudoephedrine) List II - used in manufacture of CS
What is *adequate information for use*?
this is the standard for prescription drugs. The labeling is directed to the practitioner, not the patient. Six categories of information that must be included: - Drug's indications - Side effects - Dosages - Routes, methods, frequency, and duration of administration - Contraindications - Other warnings and precautions that enable a practitioner to administer, prescribe, or dispense the drug safely.
What did the Ryan Haight Act do?
this required that online pharmacies must be registered with the DEA reporting requirement - monthly
What is the Combat Methamphetamine Act (CMEA)?
to control sale of ephedrine, phenylpropanolamine, and pseudophedrine
What is a tort?
torts = remedies for wrongs suffered by people who have no formal relationship with those who caused the alleged harm; compensation usually in the form of monetary damages
What are Qui Tam actions?
whistle-blowers actions by private persons that bring a civil action for a violation of the False Claims Act for the person and for the US government.