PHP 308 Law Exam 2- Acts & Amendments

gives all states power not vested in the federal government

10th amendment

2016: designed to help accelerate medical product development and bring new innovations and advances to patient who need them faster and more efficiently

21st century cures act

2009: signed by Obama- includes HITECH Act, which allocated over 31$ billion in stimulus funds to streamline healthcare infrastructure and effect the adoption of electrotonic healthcare records

American recovery and reinvestment act

2013: defines counterfeit drugs

DSCSA

1958: monitors additive for cancer-causing properties

Delaney clause

2007: individual patient may import an FDA approved medication under specific guidelines

Department of Homeland Security Appropriation Act

1994: altered the FDA authority in regulating dietary supplements as a special category of food; states that DS are subject to adulteration and misbranding and must comply with GMP; manufacturer is responsible for determining safety; manufacturer must file petition to FDA for new DS to evaluate efficacy, safety

Dietary Supplement Health and Education Act (DSHEA)

2006: FDA can only remove a DS on the basis that the product is adulterated, defined as presenting "significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling and if no condition of use is recommended or suggested, then under ordinary conditions of use"; requires serious events to be reported (contact info, 800# on label)

Dietary Supplement and Nonprescriptive Drug consumer Act

1951: "prescription drug amendment"; established 2 classes of drugs (legend, OTC), established labeling requirements, authorized oral prescriptions and refills

Durham-Humphrey Amendment

1938: passed as a reaction to "elixir of sulfanilamide"; considered the NUCLEUS of today's laws; to be marketed a dug must be proven safe on the label and approved by the FDA; also contains adequate directions for use, and warnings; applies to medical devises; added factory inspections and penalty provisions

FDCA

Section 301 of the ---- has to do with *adulteration, misbranding*, record keeping, GMP, counterfeits, etc; "The introduction or delivery for introduction into the interstate commerce of any food, drug, device, cosmetic that is adulterated or misbranded..."

FDCA

under 582(g)(1)(C) of the --- : systems and processes for verification of product at the package level, including standardized numerical identifier shall be required in accordance with the standards established under the guidance issues pursuant to subsection (a)(2) and the guidances issued to paragraphs 2, 3, 4 of subsection (h)

FDCA

2009: FDA given authority to regulate tobacco products

Family Smoking Prevention and Tobacco Act

2007: established FDA authority over drug recalls (medical devices, biological products, foods); classifies the recall; places manufacturers and pharmacists in charge of alerting the consumers

Food and Drug Administration Amendment Act

1942: FDA revises manufacturing and quality controls

GMP

outlines what covered entities must do to protect PHI, consider all the risks, keep track of records all to prevent breaches in info

HIPAA security rule

1996: enforced by the office for civil rights and the states' attorney general office to protect the private information of those protected by covered entities

Health insurance portability and accountability act

1962: manufacturers must ensure the safety and efficacy of a product regulated by the FDA by establishing GMP, performing clinical research, documenting ADRs, regulating advertising

Kefauver-Harris Amendments

1976: regulated medical devices to protect public from harmful or ineffective medical devices

Medical Device Amendment

1990: allows foods to contain health claims if approved by the FDA by regulation or by the 'significant scientific agreement" test

Nutrition Labeling and Education Act

starting in 2013, impermissible use/disclosure of --- presumed to require notification unless CE/BA can demonstrate low probability that --- has been compromised based on a risk assessment; *pharmacy must keep logs of breaches*

PHI

supreme court ruled that the responsible officials of a corporation as well as the corporation itself may be prosecuted for violations.

Park Doctrine

generic substitution is regulated by the ---- in the states

Pharmacy Practice Act

1944: adds regulations of biological (GMP, CDER) products eg. vaccines; licenses biosimilar products by the FDA for listing in the purple book

Public Health Services Act

1906: addressed dangerous ingredient and tonics- also introduced the terms "adulterated" and "misbranded"; did not address safety and efficacy

Pure Food and Drug Act

2018: permits eligible patient to have access to eligible investigational drugs by bypassing the FDA

Right to Try Act

1912: to overcome the ruling of US vs. Johnson; prohibits the labeling of medicines with false therapeutic claims intended to defraud the purchaser

Sherley Amendment

2013: further secure the nation's drug supply chain by creating a tighter, closed prescription drug distribution system to (1) prevent harmful drugs from entering the supply chain, (2) detect harmful drugs if they do enter the supply chain, (3) enable rapid response when such drugs are found

Title II: drug supply chain security act

In Section 201 of the FDCA: if a drug is recognized by -----, the drug product must meet all standards of the compendia or it will be misbranded/adulterated

USP/NF

2009: intended to reduce the cost of specialty products

biologics price competition and innovation act (BCPIA)

states are progressively adopting legislation regarding ------ for manufacturers and substitutions

biosimilars

1960: regulates the addition of artificial/natural coloring of food, drugs, and cosmetics

color additive amendments

1971: allows for personal use exemption of imported drugs

control substance act

November 7, 2020: --- can only buy/sell product that contain the DSCSA compliant product identifier unless the product is grandfathered product or is subject to a waiver, exception, or exemption under the law

dispensers

5-19.1-18 of this amendment requires every bottle, jar, tube, or other container of a prescription dispensed, a label shall be attached with the appropriate information.

durham-humphrey

1958: regulates components added to food by requiring premarket approval for safety

food additives amendment

2009: to protect the privacy of PHI, reduce medical errors, reduce costs by improving administrative efficiency, improving coordination among providers, and improving the public health and emergency response system

health information technology for economic and clinical health

the national conference of state legislatures requires that a biological product under consideration for substitution must first be approved as "-----" by the US FDA

interchangeable

1988: introduced DUR which became a cornerstone of OBRA 90 and expanded medicare benefits to include outpatient drugs and limit enrollees' copayments for covered services; 1st bill to significantly expands medicare benefits- *REPEALED*

medicare catastrophic coverage act

1990: changed how pharmacists practice by establishing a public expectation to improve quality of drug therapy and increase likelihood of good outcomes

omnibus budget reconciliation act

title 21 CFR Sec.310.515 includes regulation regarding the inclusion of ---- at the time of dispensing to provide the patient with adequate information regarding the drug; *not including these=misbranding*

patient package inserts

1970: intended to protect children from accidental poisoning due to "household substances: from OTCs and prescription drugs; administered by eh Consumer Product Safety Commision

poison prevention packaging act

2014: removes outdated pregnancy letter categories and introduced 3 new categories of information; must include subheadings on (1) risk summary, (2) clinical considerations, (3) data

pregnancy and lactation labeling rule

1988: passed to have states require licensure for wholesale distributers of prescription drugs, bans reimportation/resale of prescription drugs, limits drug sampling, contracts drug pricing and 340B pricing for hospitals, addresses counterfeit product sale, etc

prescription drug marketing act

3 components of OBRA impacting Rx

rebates, demonstration projects, DUR

statewide protocols are issues by a ---- or agency that authorizes pharmacists to prescribe a medication or category of medications under a protocol.

state board of pharmacy

Title 1: compounder of sterile products may voluntarily register as an 'outsourcing facility" that comply with specific requirements (does not have to be a pharmacy)

the compounding quality act: 503B

Title 1: All sterile compounding must comply with USP <797> and nonsterile <795>, exempt from cGMP requirements, not a new drug, must be dispensed pursuant to a patient specific prescription, not for resale, no mass production

the compounding quality act: Section 503A

3 T's for the Title II DSCSA for product tracing information (by 2023 they need to be readily electronically available for assessment)

transaction information, transaction statement, transaction history