Lecture 2 Flashcards
Self-Study: Statutes and Regulations (43 cards)
1
Q
FDA
A
- Within US DHHS
- Enforces laws like the Food, Drug, and Cosmetics Act
- Develops regulations based on FD&C Act or other acts under the FDA which become law
- Issues guidance (NOT law) summarizing FDA’s current thinking on a regulatory issue
- Regulates food, dietary supplements, drugs, cosmetics, medical devices, biologics, and blood products in the US
- *Supplements: Almost NOTHING is done to ensure they work as advertised, only when they are unsafe or contain regulated substances is action taken**
2
Q
Basic FDA Drug Regulation Functions (7)
A
- Approval of drugs on the basis of purity, safety, and effectiveness
- Regulation of all labeling for Rx and non-Rx drugs
- Regulation of advertising for Rx
- Regulation of manufacturing processes of drugs and institution of recalls
- Regulation of bioequivalence of generics and biosimilars
- Monitoring of drugs post-approval to detect problems with drug’s use (unexpected adverse reactions)
- Monitoring safety of nation’s blood supply
3
Q
Once a drug is determined safe and effective, how much control does the FDA have over how it is used/prescribed?
A
Little to none.
4
Q
CFR
A
- Codification of general and permanent rules (law) published by the Federal departments and agencies
- Divided into 50 titles
- Title 21 = Food and Drugs
5
Q
DEA
A
- US Federal law enforcement agency under DoJ
- Responsible for enforcement of provisions of Controlled Substances Act as they pertain to the manufacturer, distribution, and dispensing of legally produced controlled substances
6
Q
Federal v.s. State Law
A
General Rule: State has authority to set statutes that does not conflict with federal statute, may be MORE restrictive but not less
- 10th amendment gives state government authority to regulate pharmacy practice not granted to the federal government
- State statutes enforced by state agencies
- Laws relating to health, safety, and welfare of its people belong to the state MOSTLY
- Interstate common law gives federal authority to regulate drug distribution
7
Q
Statute
A
Written law passed by a legislature at the state or federal level, sets forth general propositions of law that courts apply to specific situations. May forbid a certain act, direct a certain act, make a declaration, or set forth government mechanisms to aid society.
Changing a statute requires an amendment by a legislative body
8
Q
NM Statutes
A
- Compiled in NM Statutory Authority, 1978
- Statutes = broad law and don’t encompass the details needed to regulate the practice of pharmacy
- After they are passed by legislation and signed by the governor, NM BoP passes regulations as more detailed requirements regarding the practice of pharmacy in the state
9
Q
Regulations
A
- State law gives authority to executive agencies like the BoP to develop, enact, and enforce regulations that support the statute
- Regulations are designed to increase flexibility and efficiency in the operation of laws
- Many of the actual working provisions of statutes are embodied in regulations
- Regulations are indirectly, enforceable laws
- Most regulations are developed and enacted through a rule-making process which includes public input
10
Q
Pharmacy Regulations
A
- NM BoP - state executive agency to establish/amend pharmacy regulations
- All state regulations housed in NM Administrative Code, Chapter 19 = Pharmacists
11
Q
New/Amended Regulation Process
A
- Committees, including pharmacists or other health care providers, and members of the public develop proposed or amended regulations
- Proposed regulations are presented to BoP for review
- Proposal published for public comment
- Revisions are made and BoP approves/disapproves the new regulation
- Regulation goes into effect
12
Q
Pure Food & Drug Act, 1906
A
- Prohibited the adulteration and misbranding in interstate commerce
- FAILED, lacked protection against false efficacy claims
- Didn’t regulate cosmetics or devices
13
Q
Pure Food & Drug Act, 1912
A
- Prohibited the use of false efficacy claims
- Too difficult to enforce
14
Q
Food, Drug & Cosmetics Act
A
- 1938
- Established NDA
- All drugs must be proven safe and approved by FDA
- Manufacturers had to prove safety and describe the process and quality controls
- Labels must contain “adequate” directions for use and habit forming warnings if applicable
- Established Rx-only classification
- Cosmetics and devices were included
- Drugs marketed pre-1938 were grandfathered in
15
Q
Durham-Humphrey Amendment
A
- 1951
- Established Rx and OTC classes
- Legalized verbal transmission of drug to the pharmacist
- Allowed pharmacists to provide refills if authorized on initial script
- “Caution - Federal law prohibits dispensing without script”
- Defined script label requirements - without this the script label had to have the same content as the manufacturers
16
Q
Kefauver-Harris Amendment
A
- 1962
- Drug efficacy
- Strengthen the new drug approval process, requiring drugs to be proven SAFE & EFFECTIVE
- Thalidomide fed into this law - not FDA approved for safety in the US, caused birth defects
17
Q
New Mexico
A
- Statehood: 1912
- First Compilation of Laws - enacted June 11, 1915
- Code of 1915 - served as the basis/starting points for compilation of NMSA, 1978
- Laws in NM were compiled for organization, revised, and annotated in 1978
18
Q
NM Drug, Device & Cosmetics Act
A
- Intended to protect the public by ensuring products are not contaminated, contain proper ingredients, not advertised/sold in a misleading way, properly prescribed/labeled
- Analogous to federal FD&C Act
- Specifies requirements for a script
- Prohibits adulteration, misbranding, and counterfeiting
- Specifies limitations on sale, prescribing, and possession of “dangerous” drugs
- Rx label and record keeping requirements, refill restrictions
- Empowers BoP agents to inspect factories, warehouses, and establishments that manufacture or hold drugs, devices, and cosmetics
- Empowers BoP to promulgated regulations for enforcement of the act
19
Q
Misbranding
A
False or misleading label; inaccurate statement of the quantity of the contents in terms of weight, measure, or numerical count
20
Q
Adulteration
A
Fails to meet the strength, purity, or quality which is purports or is represented to possess - OR is contaminated
21
Q
NM Drug Product Selection Act
A
- MAJOR PURPOSE: save patients money, generic and alternate source substitution
- Permits pharmacists to dispense:
1. Lower cost, “therapeutically equivalent” drug ([er Orange Book)
2. Substitute permitted unless specifically prohibited by prescribed (“No Substitution”, DAW codes)
22
Q
NM Controlled Substances Act
A
Major Purpose: Decrease diversion and abuse of controlled substances
23
Q
NM Pharmacy Act
A
- MAJOR PURPOSE: Establish BoP, regulate pharmacy profession and distribution of drugs in NM
- Establishes BoP districts (currently 5)
- Delegates powers and duties to BoP
- Record keeping requirements
- RPh licensing by examination and reciprocity
- Intern licensing requirements
- Pharmacy tech registration requirements, duties, licensure, classes of license, application requirements, inspections
- Nonresident pharmacy licensure
- Empowers BoP to require by regulation minimal pharmacy equipment and references
- Requires licenses to be displayed
- Establishes grounds for disciplinary actions
- Prohibits any person except RPh from selling, compounding any dangerous drug, possession of any dangerous substances without script, conducting pharmacy business without a license (with exceptions)
24
Q
Harrison Narcotics Tax Act
A
- 1914
- Regulated opium and narcotic use and production
- Taxes on those who prescribed, produced, and dispensed opium
- Required a prescription for opium
25
Comprehensive Drug Abuse, Prevention, and Control Act
- 1970
- Facilities must register to dispense controlled medication through the DEA via form 224
- Created schedule classes for controlled medications (I-V)
- Also created requirements for ordering controlled substances, maintaining DEA records, returning and destroying controlled substances, and filling/transferring scripts for controlled substances
26
Poison Prevention Packaging Act
- 1970
- Enacted to decrease the risk of accidental poisoning of children
- Required child-resistant packaging on most OTC with some exceptions
27
OSHA
- 1970
- Ensured employees right to a safe and healthy workspace
- Reduction in hazardous work environments
28
Drug Listing Act
- 1972
| - Created 11-digit NDCs
29
Orphan Drug Act
- 1983
- Orphan drugs treat conditions that affect 200,000 people or less worldwide
- Gave tax incentives and sole property rights for 7 years if a company developed an orphan drug
30
Drug Price Competition and Patent Term Restoration Act
- 1984
- AKA Hatch-Waxman Act
- Amended the FD&C Act to streamline generic drug approval
- Created the ANDA
31
Prescription Drug Marketing Act (PDMA)
- 1987
- Designed to prevent counterfeit drugs from entering the market
- Reinforced a standard route that drug products follow from drug manufacturers to wholesalers to pharmacies
32
FDA Modernization Act
- 1997
- Aimed to streamline the FDA's approval process to more rapidly get drugs on the market
- Also helped fast track medications for life threatening conditions
33
Omnibus Budget Reconciliation Act
- OBRA
- Prevented use of medications not necessary for the patient's conditions
- Addressed the quality of healthcare for elderly covered under Medicare
34
Anabolic Steroid Control Act
- 1990
- Established penalties for those who abuse and misuse anabolic steroids
- Moved anabolic steroids (related to testosterone) to schedule III
35
Omnibus Budget Reconciliation Act, 1990
- OBRA
- Established standards for patient counseling
- Established drug utilization reviews (DUR)
36
Dietary Supplement Health and Education Act
-1994
-DSHEA
-Allowed creation of regulations for herbal products
-Required the statement that the product is a dietary supplement
-Required herbal products to list their ingredients and quantities and meet standards for purity, quality, and
composition, and production
37
HIPPA
- 1996
- Established PHI
- Must protect, respect, store, and dispose of PHI properly
- Requires patient authorization to share or disclose PHI
38
Drug Addiction Treatment Act
- 2000
- DATA
- Broadened the rights of prescribers to prescribe medications for those suffering from opiate addiction
39
Medicare Drug, Improvement, and Modernization Act
- 2003
- MPDIMA
- Attempts to modernize the Medicare system
- Added prescription Medicare coverage, Part D
40
Isotretinoin Safety and Risk Management Act
- 2004
- Required registration or restrictions to the prescribing and dispensing of Isotretinoin
- Isotretinoin is used for acne but causes birth defects, spontaneous abortions, and psychiatric side effects
41
Combat Methamphetamine Epidemic Act
- 2005
- Any products containing pseudoephedrine, ephedrine, and phenylpropanolamine have a sales limit of 3.6 g per day, and 9 g in a 30-day period
42
Medicaid Tamper-Resistant Prescription Act
-2008
-All handwritten prescriptions filled for patients who
have Medicaid paying any part of the cost must be written on tamperresistant paper.
43
USP <797>
-Compounding requirements for sterile products
-Training and evaluation for all personnel who
are to use aseptic technique for preparing sterile products, assigning responsibility to the personnel involved in compounding
-Cleanliness and air levels specified in sterile compounding rooms
