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1

FDA

-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

Basic FDA Drug Regulation Functions (7)

1. Approval of drugs on the basis of purity, safety, and effectiveness
2. Regulation of all labeling for Rx and non-Rx drugs
3. Regulation of advertising for Rx
4. Regulation of manufacturing processes of drugs and institution of recalls
5. Regulation of bioequivalence of generics and biosimilars
6. Monitoring of drugs post-approval to detect problems with drug's use (unexpected adverse reactions)
7. Monitoring safety of nation's blood supply

3

Once a drug is determined safe and effective, how much control does the FDA have over how it is used/prescribed?

Little to none.

4

CFR

-Codification of general and permanent rules (law) published by the Federal departments and agencies
-Divided into 50 titles
-Title 21 = Food and Drugs

5

DEA

-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

Federal v.s. State Law

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

Statute

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

NM Statutes

-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

Regulations

-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

Pharmacy Regulations

-NM BoP - state executive agency to establish/amend pharmacy regulations
-All state regulations housed in NM Administrative Code, Chapter 19 = Pharmacists

11

New/Amended Regulation Process

1. Committees, including pharmacists or other health care providers, and members of the public develop proposed or amended regulations
2. Proposed regulations are presented to BoP for review
3. Proposal published for public comment
4. Revisions are made and BoP approves/disapproves the new regulation
5. Regulation goes into effect

12

Pure Food & Drug Act, 1906

-Prohibited the adulteration and misbranding in interstate commerce
-FAILED, lacked protection against false efficacy claims
-Didn't regulate cosmetics or devices

13

Pure Food & Drug Act, 1912

-Prohibited the use of false efficacy claims
-Too difficult to enforce

14

Food, Drug & Cosmetics Act

-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

Durham-Humphrey Amendment

-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

Kefauver-Harris Amendment

-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

New Mexico

-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

NM Drug, Device & Cosmetics Act

-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

Misbranding

False or misleading label; inaccurate statement of the quantity of the contents in terms of weight, measure, or numerical count

20

Adulteration

Fails to meet the strength, purity, or quality which is purports or is represented to possess - OR is contaminated

21

NM Drug Product Selection Act

-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

NM Controlled Substances Act

Major Purpose: Decrease diversion and abuse of controlled substances

23

NM Pharmacy Act

-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

Harrison Narcotics Tax Act

-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