What Are the Laws Governing Pharmacy Practices?

Pharmacies are regulated at both the state and federal levels.
Pharmacies are regulated at both the state and federal levels. (Image: préparatrices en pharmacie image by cédric chabal from Fotolia.com)

The practice of the pharmacy profession is regulated in the United States. Pharmacists play a key role in the health-care field. The functions of pharmacists are to store, label medicine and manage its dispensation. Pharmacists also advise patients on the interactions of drugs, their dosages and side effects.

Each state has its own rules and regulations affecting the practice of the profession. As with any licensed profession, there are licensing and educational requirements in order to be admitted to the profession. There are also regulations affecting the management and operation of each practice. Pharmacists must also meet their state’s requirements for continuing education. Finally, there are special regulations for the storage and dispensation of poisons and controlled substances.

The Requirement of Obtaining a License

To receive a license to practice the profession, in New York state a candidate must first obtain a bachelor’s degree in pharmacy, complete and submit the state’s application, show good moral character and pass the state’s licensing examination. The State of California has similar requirements. The statutes contain exceptions to accommodate individuals who have the educational equivalent of the bachelor's degree either through course work or through work experience.

Laws Regulating the Operation of a Pharmacy Practice

The laws regarding the operation and management of a pharmacy practice cover such items as the registration requirements for each practice location, maintaining shipment records, and making price lists available to the public. There are regulations specifying the proper manner of handling and issuing prescriptions. The provisions include a requirement that certain records be maintained and prohibitions against adulterating, mislabeling and substituting drugs.There are also regulations for the proper storage, labeling and dispensation of drugs.Both New York and California have regulations that control the sale and dispensation of hypodermic syringes and needles.

Laws Regarding Continuing Education

In both California and New York, the applicable regulations require that a pharmacist further his education with continuing education courses. In California, a pharmacist’s license will not be renewed unless the applicant submits proof that he has completed 30 hours of approved courses.In New York, a pharmacy license will not be renewed unless the registrant completes 45 hours of approved continuing education study.

Poisons and Controlled Substances

Pharmacists are subject to special regulations for the storage and dispensation of poisonous substances. Poisons are to be kept in a locked cabinet and stored separately from other medications. The New York statute contains a schedule of poisonous substances. The substances on this schedule cannot be sold unless they are clearly labeled as poison. The label must further specify the name of the substance and bear the name and address of the purchaser and the name and address of the pharmacy establishment. The pharmacy establishment shall also keep a book that contains a record of the sale, including the name of the purchaser and the stated purpose for the purchase and the date of sale.

The state laws also include provisions for the dispensation of controlled substances by prescription. These rules also contain special record-keeping instructions for each transaction.

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