Pharmacy Laws

PHARMACY PRACTICE LAWS

FEDERAL MANDATES

1906: U.S. Food and Drug – FDA -Accountability for drugs and safety of patients

1906: U.S. Food, Drug and Cosmetic act- FDC act- prevent adulteration of drugs or misbranding; (after 100 deaths from drug with antifreeze and 100 deaths (mostly children) from a sulfa drug in unknown solvent.

1951: Durham-Humphrey Amendment- prevent counterfeit drugs

1970: U.S. Controlled Substance Act- CSA- Comprehensive Drug Abuse Prevention and Control-fight against the abuse of drugs and other
substances U.S. Drug Enforcement Administration-DEA- classified controlled substances: Cl, Cll, Clll, ClV, &CV

Department of Health and Human Services: Protecting the health of all Americans

1970: Poison Prevention Packaging Act- PPPA -packaging of drugs and household items and as it per under The Consumer Product Safety Commission-CPSC

1987: Prescription Drug Marketing Act- PDMA- Control the diversion of drugs: the sale and purchase of drug samples and Non-Profit Hospital Institutions Act of
1938_ the resale of drugs purchased at a cheap rate under “Inpatient” contracts and the marked higher in their Retail Pharmacy.

1990: Omnibus Budget Reconciliation Act-OBRA- provision to enhance savings on Government-subsidized healthcare plans for Medicare and Medicaid, utilizing Patient Counseling and Prospective Drug Utilization
Review: ProDUR as follows:
1) Therapy Duplication
2) Drug-Disease Contraindications
3) Drug-Drug Interactions
4) Incorrect Drug Dosage
5) Incorrect Duration of Treatment
6) Drug-Allergy Interactions
7) CLinical Abuse and Misuse of Medication

Center for Medicare and Medicaid-CMS-provider identification number

1996: Health Insurance Portability and Accountability Act-HIPAA:
protect patient privacy
2003: Protected Health Information Act (under HIPAA) – safeguard
patients’ health information that is transmitted electronically: 5
provisions:
1) limit the disclosure of health care information by use of policies
and procedures and

POST PRIVACY ACTS AT EACH HEALTHCARE FACILITIES AT PROMINENT LOCATIONS
INCLUDING WEBSITES.

2) Develop and distribute clear explanation of rights and practice with written acknowledgements from patients.

3) Each Facility should appoint a Compliance officer, who will manage and ensure compliance.

4) All employees, professionals (including pharmacists, technician, & others) at a facility must receive training and a signed document kept
for validation.

5) Disclosure to business associates, e.g. billing, claims, etc. need a written contract.

2005: Security Provision of HIPAA: protect unauthorized access during transmission- protect administrative, physical and technical areas of technologies to maintain confidentiality, integrity, and availability.

Occupational Safety and Health Administration- It requires a poster visible to all employees and protect workers from hazardous exposure, including chemicals such as chemotherapy agents and length of exposure.
Issues such as job fatigue and extraordinary demands are addressed and provide more information to employees in order to foster a healthy environment.

United States Pharmacopoeia- USP 797- To decrease infections transfered to patients from pharmaceutical products or healthcare procedures.

Joint Commission on Acreditation of Healthcare Organizations-JCAHO-ensures uniform standars are enforced. It is also used, by the U.S. Government to assign facilities with Medicare and Medicaid services

Center for Disease Control and Prevention-CDC- addressing transmittable disease such as Hepatitis, HIV, etc. National Institute of Health- NIH- converts research to health interventions

FLORIDA STATE LAWS

Board of Pharmacy-Licensure

National Association of Board of Pharmacy-NABP- provide online tracking NABP e-number) of Continuing Education monitor high standards among states, including Canada, Australia and New Zealand

Drug Abuse Prevention and Control- drug, alcohol and substance abuse.

Agency for Healthcare Administration- ACHA- healthcare regulatory and enforcement agency

INSURANCE: practice insurance