Retail Pharmacy Laws

1. Retail Pharmacy Laws Angela Singh, PharmD Assistant Professor of Pharmacy FAMU COPPS IPPE I

2. Federal Laws • Food, Drug and Cosmetic Act (FDCA) • Controlled Substance Act (CSA) • Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) • Health Insurance Portability and Accountability Act ( HIPAA) • Combat Meth Act; Public Law 109-177

3. Food Drug & Cosmetic Act (FDCA) 1938 • Brought about by the elixir of sulfanilamide incident. • Drugs marketed before 1938 were exempt. • Requires that product manufacturers prove their product is safe and effective for use under conditions set forth. • Prohibits the introduction of misbranded or adulterated foods, drugs or devices, including cosmetics.

4. Food, Drug & Cosmetic Act cont. • Legal Prescribers • Requirements for Prescription Label • Requirement for Prescription Refills

5. Controlled Substances • The Attorney General for the US designates a drug as a controlled substance. • Criteria to evaluate and classify a substance as a controlled substance. • Actual or relative potential for abuse • Scientific evidence of its pharmacological effects. • Its history and current patterns of abuse • The scope, duration, and significance of abuse • Extent of risk to public health • Liability of psychological or physiological dependence. • Chemical similarity to another controlled substances.

6. CSA • Main federal law regulating the manufacture, distribution and dispensing of controlled substance. • Enforced and regulated by DEA • FDA retains authority to regulate some habit-forming drugs. • Five Schedules • Schedule I substances with the highest abuse potential may not be marketed in the US.

7. Classification of Controlled Substances • Schedule I: Drugs with no accepted medical use in the US; high potential for abuse and lack of accepted safety for use under medical supervision. • Schedule II: Drugs with acceptable medical use but a high potential for abuse including severe psychological and physical dependence. • Schedule III: Drugs with acceptable medical use and less potential for abuse, low to moderate potential for physical dependence, but high potential for psychological abuse

8. Classification of Controlled Substances • Schedule IV: Drugs with acceptable medical use and less potential for abuse than schedule III drugs and a limited potential for psychological and physical dependence. • Schedule V: Drugs with acceptable medical use and less potential for abuse than the Schedule IV drugs; limited potential for psychological and physical dependence.

9. Prescription Requirements • Full name and address of the patient • Name, strength and quantity of medication • Directions for use • Date of issuance • Actual signature of the prescriber • Full name, address and the DEA number of the prescriber. DEA number should be identified before the drug is dispensed.

10. Dr. Byron Brown's DEA number is:AB1212125 • This is how you would validate the above DEA number;1. Add the 1st, 3rd, and 5th digits.1 + 1 + 1 = 3 • 2. Add the 2nd, 4th, and 6th digits.2 + 2 + 2 = 6 • 3. Multiply the result of the previous step by 2.2x 6 = 12 • 4. Add the results of the 1st and 3rd steps.3 + 12 = 15 • 5. The DEA number is valid if the last digit of the result in the previous step is the same as the last digit of the DEA number. Also, the second letter of the DEA number has to be the first letter of the doctor's last name. Finally, the first letter of the DEA number has to be an A or a B. Since all of these conditions were met, this DEA number is valid Determining the Validity of a DEA Number

11. Omnibus Budget Reconciliation Act (OBRA) ‘90 • Requires comprehensive drug review and an offer to counsel by a pharmacist for patients or their caregivers. • Eight areas must be covered: • Name and description of the medication • Route of administration • Dosage • Dosage Form • Special directions and precautions for preparation, administration and use by the patient. • Common side effects • Drug interactions • Self-monitoring therapy and storage.

12. HIPAA • Creates uniform standards for electronic health care transactions (EDI), establishes security protections for data that is electronically stored and transmitted (Security), and sets forth privacy rights for individuals regarding their personally identifiable health information (Privacy).

13. HIPAA • Limits the ways that health plans, pharmacies, hospitals and other entities can use patients’ personal medical information. • Protects medical records and other individually identifiable health information, whether it be on paper, in computers or communicated orally.

14. HIPAA: Patient Protectors • Access to Medical Records • Notice of Privacy Practices • Limits on Use of Personal Medical Information • Prohibition on Marketing • Stronger State Laws • Confidential Communications • Complaints

15. HIPAA: Health Plans & Providers • Written Privacy Procedure • Employee Training and Privacy Officer • Public Responsibilities • Equivalent Requirements for Government

16. HIPAA: Civil and Criminal Penalties • For civil violations monetary penalties of $100 per violation, up to $25,000 per year for requirement or prohibition violated. • Criminal penalties apply for certain violations, such as knowingly obtaining health information in violation of the law. • Criminal penalties range from $50,000 to $100,000 dollars in penalties and 1-10 years in prison.

17. Combat Meth Act • Effective September 30,2006 • Requires that products containing pseudoephedrine, ephedrine, and phenylpropanolamine to be placed behind the counter or in a locked cabinet. • Customer may not exceed: • 3.6 grams on daily purchase • 9.0 grams on 30-day purchase

18. Combat Meth Act: Logbook • Purchasers must present a photo ID AND sign a log book. • Exception for purchases of 60 mg or less of pseudoephedrine. • Logbook must contain the following: • The product name • The quantity sold • Name and address of purchaser • Dates and times of sales

19. Questions???????????????? angela.singh@famu.edu 599-3369 #345 New Pharmacy Bldg.