Pharmacy Law and Regulations Overview

Competency statements

Blueprint for the MPJE exam

Malpractice Liability

Requires establishing duty, breach, proximate cause, and damages

Area 1 = Licensure/Personnel

Includes responsibilities, limitations, licenses, renewals, and disciplinary actions

Area 2 = Pharmacist Practice

Covers requirements for prescriptions, drug use, prescriber authority, vaccines, counseling, and agencies

Area 3 = Dispensing Requirements

Involves responsibility for legitimate prescriptions, transfers, monitoring programs, labeling, exceptions, recalls, and distribution

Area 4 = Pharmacy Operations

Encompasses drug ordering, recordkeeping, non-dispensing requirements, storage, compounding, and inspection

Regulation of Drugs

Primarily for health and safety, addressing market failures and insufficiencies

Public Goods

Necessary commodities not supplied by private enterprise without government intervention

Externalities

Costs not included in prices affecting those not consenting to the effect

Natural Monopolies

High fixed costs relative to variable costs, justifying patents to prevent unfair competition

Informational Asymmetry

Consumer unawareness of a good's true value, necessitating disclosure of benefits and risks by drug companies

Food, Drug, and Cosmetic Act

One of the two main laws governing pharmacy on a federal level

Controlled Substances Act

Second main law governing pharmacy federally, with parallel state laws in many states

Pennsylvania Pharmacy Act

Primary law affecting pharmacy in Pennsylvania

Statute vs. Regulation

Statutes enacted by legislatures, regulations by agencies, with regulations providing richer details

Three Sources of US Law

Constitution, statutes, and regulations, with the Constitution being supreme

Proper Clause

Allows Congress to regulate pharmacy/drug companies at the federal level

Commerce Clause

Enables Congress to regulate pharmacy/drug companies at the federal level

Legislative or Statutory Law

Laws enacted by legislatures such as Congress or state legislatures

Administrative Agency Law

Involves agencies created by legislators to administer substantive law

Notice and Comment Rulemaking

Process where agencies provide notice and allow comments from the community before enacting regulations

Enabling Statute

Law that gives an agency the authority to enact regulations

Federal Register

Publication where federal regulations are posted for public view

State Board of Pharmacy

Agency that administers the Pharmacy Act at the state level

Code of Federal Regulations (CFR)

Publication listing final federal regulations as adopted

Pennsylvania Bulletin

Weekly publication listing proposed regulations and other notices at the state level

Pharmacy Act

Primary statute governing pharmacy practice at the state level

Controlled Substance Act

Federal law administered by the DEA regulating controlled substances

Independence Regulatory Review Commission

Commission that approves or comments on regulations before adoption by the State Board

Title 49, Ch 27

Location of accompanying regulations for the Pharmacy Act in Pennsylvania

Malpractice Claim Elements

Consist of duty, breach, and damage

HIPAA Authorization Form

Document signed by a patient allowing release of their medical records

FDA, DEA, and DoH

Agencies responsible for regulatory oversight in the United States

Senate and the House of Representatives

Legislative bodies that are not considered agencies

Age requirement for purchasing syringes

Not applicable in a specific jurisdiction for over-the-counter syringe purchases

Purchasing limit for insulin syringes

There is no specified limit for purchasing insulin syringes

Regulations vs. Statutes

Pharmacists must adhere to both; regulations are more detailed and specific than statutes

Regulations and Statutes enactment

Agencies enact regulations, while legislatures enact statutes

Pure Food and Drug Act of 1906

First significant attempt to regulate drug safety in the United States

Misbranding under Pure Food and Drug Act

Initially did not include false, misleading efficacy claims as misbranding

Durham Humphrey Amendment of 1951

Established prescription and over-the-counter drug classes

Kefauver Harris Amendment of 1962

Required drugs to be proven effective, in addition to safe

Medical Device Amendments of 1976

Enhanced safety and efficacy review processes for medical devices

Orphan Drug Act of 1983

Provides incentives for developing drugs for rare diseases affecting less than 200,000 people in the US

Drug Price Competition and Patent-Term Restoration Act of 1984

Introduced accelerated approval for generic drugs and patent extensions for pioneer drugs

Prescription Drug Marketing Act of 1987

Enacted to regulate drug sample sales and prevent resale of discounted drugs

Dietary Supplement Health and Education Act of 1994

Defines dietary supplements and allows specific claims under certain conditions

Food and Drug Administration Modernization Act of 1997

Streamlined FDA processes for quicker drug and device approvals

Food and Drug Administration Amendments Act of 2007

Mandated safety-related labeling changes and post-market studies for drugs

Drug Quality and Security Act of 2013

Implemented to enhance oversight of compounding pharmacies and track drug distribution

Drug

Articles used in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect structure or function

Device

Articles that affect structure or function without achieving their principal intended purpose through chemical action on the body

Dietary Supplement

Product for ingestion containing vitamins, minerals, herbs, or amino acids, not requiring FDA premarket approval

Label

Display of written, printed, or graphic matter on a product container or accompanying article

USP/NF

United States Pharmacopeia/National Formulary, established in 1820, setting drug standards

Durham Humphrey Amendment

Created RX and OTC drug classes, requiring prescriptions for certain drugs under specific conditions

General Labeling Requirements

Requirements include not being false or misleading, not imitating other drugs, and conforming to official standards.

Prescription Label Requirements (Per D-H Act)

Includes dispenser's name and address, serial number, prescriber's name, patient's name, directions for use, and cautionary statements.

Prescription Label Requirements in PA

Includes pharmacy details, patient's name, directions, prescriber's name, serial number, fill date, drug name, strength, dosage form, quantity, and manufacturer for generics.

Beyond-Use Dates

Guidelines suggest a date not later than the manufacturer's expiration date or one year from dispensing, whichever is earlier.

Unit-dose containers

The Beyond-Use Date (BUD) is one year from repackaging or the expiration date on the bulk container, unless stability data indicates otherwise.

Switching of a product from prescription to OTC status

Process includes manufacturer requests to FDA, granting OTC status exclusively to approved manufacturers.

Prescription Refill Authorization

Physicians cannot delegate prescriptive authority, but agents can transmit refill authorizations to pharmacists.

Specific Prescriptive Authority in PA

Different mid-level practitioners have varying prescriptive authorities granted by individual states, not federally.

Certified Registered Nurse Practitioners (CRNPs)

Have a negative formulary excluding specific drug classes, with controlled substance prescription limits.

Physicians Assistant (PA)

Prescriptive authority depends on the agreement with the supervising physician, with no negative formulary currently in place.

CIIs

Controlled substances that Physician Assistants (PAs) can prescribe for an initial 72 hr supply or 30 days supply for ongoing therapy if permitted by the supervising physician

CIII-V

Controlled substances that PAs can prescribe for up to a 30-day supply and authorize up to 5 refills within a 6-month period

Optometrists

Eye care professionals who can prescribe various topical and oral medications based on their certifications; treatment duration limited to 6 weeks without consultation with a licensed physician

Therapeutically Certified Optometrist

An optometrist certified to prescribe specific medications but restricted from prescribing parenterals, Beta blockers, systemic condition drugs, or glaucoma medications

Glaucoma Certified Optometrist

An optometrist certified to prescribe medications used in the treatment of glaucoma

Certified Nurse Midwife

Healthcare professionals who can prescribe medications based on collaborative agreements with physicians, limited CII-V prescribing, and controlled substance limits for acute pain

Levonorgestrel Emergency Contraception

Emergency contraceptives like Plan B, Take Action, My Way, with evolving age restrictions over the years

Patient Package Inserts

Informational inserts required for specific medications like contraceptives and intrauterine devices; FDA policy transitioned to medication guides

Medication Guides

Replaced patient package inserts for informing patients about medications; FDA determines need based on preventing adverse effects, influencing product use decisions, and critical adherence to directions