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)

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