USP, controlled substances, laws

USP 795

Non-sterile compounding. Enforces Beyond-Use-Dates for non-sterile formulations

BUD for non-aqueous formulations

earliest expiration date of any API or 6 months, which ever is shorter.

BUD for water-containing oral formulation

Max 14 days when stored in a controlled refrigerated temperature (2 to 8C)

BUD for water-Containing topical/Mucosal/Dermal formulations

max 30 days at controlled room temperature

USP 797

Sterile compounding

Primary Engineering Control

Laminar Airflow Workbench or Compounding Aseptic Isolator providing an ISO class 5 environment

Buffer room

Cleanroom, where the sterile compounding takes place, minimum ISO class of 7

Anteroom

Garbing and hand hygiene area, ISO class of 8

USP 800

Hazardous drugs

Schedule II refills

0 refills allowed

Schedule III & IV refills

Max 5 refills 6 months from date written

Schedule V refills

Refills as authorized by prescriber, up to 12 months

DEA form 222

Used for ordering, transferring, or returning schedule II drugs.

DEA form 106

Used to report the theft or significant loss of controlled substances. Must immediately report to the DEA once discovered.

DEA form 41

Used to request the authorization to destroy outdated, damaged, or unwanted controlled substances,

DEA form 224

Initial registration form for retail pharmacies, hospitals, clinics, and practitioners to dispense controlled substances. Must renew every 3 years.

Inventory check for controlled substances

Biennially check (every 2 years)

Occupational Safety and Health Act (OHSU) of 1970

Ensures safe and healthful working conditions for employees by establishing and enforcing workplace safety standards

OHSA standards in a pharmacy setting

Requires; Safety Data Sheets (SDS). proper hazardous drug handling, exposure control plans, and eye wash stations

Controlled Substances Act (CSA) of 1970

Consolidates federal regulations of controlled substances, created a legal framework to classify drugs based on medical use and abuse potential

Enforcement agency for the controlled substances act

Drug Enforcement Administration (DEA)

Poison Prevention Packaging Act (PPPA) of 1970

Requires most prescriptions and OTC drugs to be packaged in child-resistant containers

PPPA child-resistant packaging standard

Packaging that cannot be opened by 80% of children under 5 years old, but can be opened by 90 %of adults

Exceptions to PPPA child resistant packaging

Sublingual nitroglycerin, oral contraceptives in memory-packs, prescribers/patients, requesting non-CR caps, certain powder formulations

Drug listing act of 1972

National Drug code system (NDC)

10-digit national drug code structure

Labeler code (4-5 digits), product code (3-4 digits), package code (1-2 digits)

Drug listing act of 1972 - Mandatory registry requirment

Requires registered drug establishments to provide FDA with a complete list of all commercial drug products manufactured, prepared, or processed

Prescription Drug Marketing Act (PDMA) of 1987

Prevents Drug diversions, counteracts counterfeit/adulteration of drugs, and restricts reimportations of U.S.-manufactured prescription drugs

PDMA regulations on Rx drug samples

bans retail pharmcies from possessing, distributing, or receiving drug samples; would first need written practitioner requests.

PDMA restrictions on reselling Rx drugs

Prohibits the reselling of Rx drugs to other entities

Omnibus Budget Reconciliation Act of 1990

Mandates Drug Utilization Review (DUR) programs and mandates patient counseling offers for Medicaid beneficiaries

Three components of OBRA ‘90

Prospective DUR (Screening before dispensing), retrospective DUR (evaluating patterns post-dispensing), and educational programs

Class recall: 1

For risk of “serious adverse health consequences or death”

Class recall: 2

For risk of “temporarily or medically reversible adverse health consequences” or low-probability of serious adverse health consequences