Lecture 2 Flashcards
Self-Study: Statutes and Regulations
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
