FEDERAL REQUIREMENTS — Regulatory Agencies

FDA

Food and Drug Administration; evaluates drug safety and helps ensure the safety, efficacy, and security of human and veterinary products.

FDA and new drugs

FDA reviews new drug applications and investigational drug applications.

FDA and MedWatch

FDA reviews information submitted through MedWatch.

FDA and REMS

FDA maintains the REMS list.

FDA and medical devices

FDA approves/clears medical devices and issues alerts, notices, and recalls.

DEA

Drug Enforcement Administration; enforces the Controlled Substances Act as it relates to legally produced controlled substances.

DEA main role

Regulates/enforces laws involving the manufacture, distribution, and dispensing of controlled substances.

CSA

Controlled Substances Act.

USP

United States Pharmacopeia; establishes standards for the identity, strength, quality, and purity of medications and other covered products.

USP-NF

United States Pharmacopeia–National Formulary; contains official standards for drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.

USP <795>

USP requirements involving nonsterile compounding.

USP <797>

USP requirements involving sterile compounding/infection control.

TJC

The Joint Commission; addresses quality of patient care and patient safety and accredits healthcare providers.

TJC and medication errors

TJC addresses patient-safety concerns including medication errors.

OSHA

Occupational Safety and Health Administration; establishes/enforces standards intended to provide safe and healthy working conditions.

OSHA and SDS

OSHA requires Safety Data Sheets to be maintained in the pharmacy for medications and hazardous compounds.

NIOSH

National Institute for Occupational Safety and Health; establishes a list of drugs considered hazardous and requiring special handling.

BOP

State Board of Pharmacy; state regulatory agency overseeing pharmacy practice within a state.

State Board of Pharmacy authority

Can establish regulations and discipline pharmacies, pharmacists, and technicians for improper behavior.

NABP

National Association of Boards of Pharmacy; composed of state Boards of Pharmacy.

Does NABP have regulatory authority?

No.

NABP responsibilities

Includes pharmacist license reciprocity monitoring, NAPLEX/MPJE administration, online pharmacy accreditation, and maintaining the CPE Monitor system.