This space is reserved for an article that will be posted here shortly. In the mean time please check out the article on Federal pharmacy law.

The pharmaceutical industry is a highly regulated industry with laws impacting it dating back as far as the Pure Food and Drug Act of 1906 to the Kefauver-Harris Amendment of 1962 to various impacts from the Patient Protection and Affordable Care Act of 2010, and many laws in between. Despite being a highly regulated industry already, according a recent (2010) Harris Poll, 10% of Americans would like to see an increase in regulation on pharma and drug companies. With that in mind, there are sure to be additional regulations placed on the industry in the future.

This article will focus on the following knowledge areas to provide an overview of pharmacy laws and regulations:

• Storage, handling, and disposal of hazardous substances and wastes (e.g., MSDS)

Hazardous substances exposure, prevention and treatment (e.g., eye wash, spill kit, MSDS)

• Controlled substance transfer regulations (DEA)
• Controlled substance documentation requirements for receiving, ordering, returning, loss/theft, destruction (DEA)
• Formula to verify the validity of a prescriber’s DEA number (DEA)
• Record keeping, documentation, and record retention (e.g., length of time prescriptions are maintained on file)
• Restricted drug programs and related prescription-processing requirements (e.g., thalidomide, isotretinoin, clozapine)
• Professional standards related to data integrity, security, and confidentiality (e.g., HIPAA, backing up and archiving)
• Requirement for consultation (e.g., OBRA-90)
• FDA’s recall classification
• Infection control standards (e.g., laminar air flow, clean room, hand washing, cleaning counting trays, countertop, and equipment) (OSHA, USP 795 and 797)
• Record keeping for repackaged and recalled products and supplies (TJC, BOP)
• Professional standards regarding the roles and responsibilities of pharmacists, pharmacy technicians, and other pharmacy employees (TJC, BOP)
• Reconciliation between state and federal laws and regulations
• Facility, equipment, and supply requirements (e.g., space requirements, prescription file storage, cleanliness, reference materials) (TJC, USP, BOP)

Terminology

To get started with, there is some terminology that should be defined.

National Institute for Occupational Safety and Health (NIOSH) - NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS). NIOSH is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Of particular interest to pharmacy is their role in establishing a list of Hazardous Drugs (HDs).

hazardous drugs (HDs) - Hazardous drugs are identified as hazardous or potentially hazardous based on the following six criteria:

• carcinogenicity, which is the ability to cause cancer in animal models, humans or both;
• teratogenicity, which is the ability to cause defects on fetal development or fetal malformation;
• drugs are known to have the potential to cause fertility impairment;

organ toxicity at low doses in humans or animals;

• genotoxicity, which is the ability to cause a change or mutation in genetic material; and
• new drugs that mimic existing HDs in structure or toxicity.

These drugs are often classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents, and/or immunosuppressive agents. As of writing this text the 2014 NIOSH list of HDs is the current standard and may be found at http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf

Occupational Safety and Health Administration (OSHA) - OSHA is a government agency within the United States Department of Labor responsible for maintaining safe and healthy work environments.

Material Safety Data Sheet (MSDS) - OSHA-required notices on hazardous substances which provide information on potential hazards associated with a particular material or product, safe handling procedures, proper clean-up, and first aid information.

personal protective equipment (PPE) - Personal protective equipment is worn by an individual to provide both protection to the wearer from the environment or specific items they are manipulating, and to prevent exposing the environment or the items being manipulated directly to the wearer of the PPE.

Drug Enforcement Administration (DEA) - The Drug Enforcement Administration (DEA) is a United States Department of Justice law enforcement agency, a federal police service tasked with enforcing the Controlled Substances Act of 1970.

controlled substances - Controlled substances are medications with restrictions due to abuse potential. There are 5 schedules of controlled substances with various prescribing guidelines based on abuse potential, counter balanced by potential medicinal benefit as determined by the Drug Enforcement Administration and individual state legislative branches.

Risk Evaluation and Mitigation Strategy (REMS) - The Food and Drug Administration may require risk evaluation and mitigation strategies (REMS) on medications, if necessary, to minimize the risks associated with some drugs. REMS may require a medication guide, a communications plan, elements to assure safe use, an implementation plan, and a timetable for submission of assessments.

United States Pharmacopeia (USP) - The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, and is published dually with the National Formulary as the USP-NF. Prescriptions and over-the-counter medicines, and other healthcare products sold in the United States, are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below 1000 are considered enforceable, while chapters enumerated as 1000 or greater are considered guidelines. Therefore, USP 797 and USP 795 are considered enforceable, while USP 1160 and USP 1176 are simply considered guidelines for best practices.

compounded sterile preparations (CSP) - Compounded sterile preparations are admixtures that need to be assembled under aseptic conditions to prevent contamination.

1. The Harris Poll, Americans Less Likely to Say 18 of 19 Industries are Honest and Trustworthy This Year, December 12, 2013, http://www.harrisinteractive.com/vault/Harris%20Poll%2096%20-%202013%20Industry%20Regulation_12.12.2013.pdf