Pharmacy Law & Safety Essentials

01Controlled substance refill rules

Schedule II prescriptions cannot be refilled — a new prescription is required for every fill. Schedule III and IV prescriptions are limited to a maximum of 5 refills within 6 months of the date issued. Schedule V has no federal refill cap under the CSA.

02HIPAA and the minimum necessary standard

Pharmacy staff may only access, use, or disclose the minimum amount of a patient's protected health information needed for the task at hand, and should verify identity with two identifiers before releasing prescription information.

03Look-alike/sound-alike (LASA) drugs

Some drug names are commonly confused because they look or sound similar, such as hydroxyzine (antihistamine) and hydralazine (blood pressure medication). Careful verification of drug name, strength, and NDC at data entry and dispensing helps prevent mix-ups.

04Medication error and near-miss reporting

Errors and near misses should be reported through the pharmacy's internal system and, when applicable, programs like ISMP's Medication Errors Reporting Program. Non-punitive reporting treats errors as systemic issues to fix rather than individual blame, which encourages more complete reporting.

05Pseudoephedrine sales restrictions

Under the Combat Methamphetamine Epidemic Act, pseudoephedrine products are kept behind the counter, require photo ID and a logged purchase record, and are capped at 3.6 grams per day and 9 grams per 30-day period per purchaser.