drug law & regulations
DESCRIPTION
TRANSCRIPT
![Page 1: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/1.jpg)
1
Development of Drug Regulations
FDAFDA Food & Drug Administration
FTCFTC Federal Trade Commission
DEADEA Drug Enforcement Agency
![Page 2: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/2.jpg)
2
![Page 3: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/3.jpg)
3
A Timeline 1906 Pure Food and Drug Act 1938 Food, Drug and Cosmetic Act 1951 Durham-Humphrey Amendment 1962 Kefauver-Harris Amendment 1970 Controlled Substances Act 1990 Omnibus Budget Reconciliation Act 1996 Health Insurance Portability &
Accountability Act (HIPAA)
![Page 4: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/4.jpg)
4
Controlled Substances Schedule I
Heroin,THC Schedule II
Methadone Schedule III
Valium, Vicodin Schedule IV
Alprazolam, Darvocet Schedule V
Lomotil
![Page 5: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/5.jpg)
5
![Page 6: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/6.jpg)
6
![Page 7: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/7.jpg)
7
Security Rx FormTamper Resistant Features Thermochromic ink
Symbl/text temp. changes color w/heat Single or Multiple Drug Statement Description of security features
Required by law Refills/DNS/Unit/Quantity Check box Opaque Writing
Disappears if rx is lightened
![Page 8: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/8.jpg)
8
More Security Components Prescriber information Batch/Lot Number Latent Repetitive Void
Appears if scanned, copied, or faxed Watermark
California Security Prescription printed on back, seen at an angle
Chemical Void Appears prevents chemical washing
![Page 9: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/9.jpg)
9
![Page 10: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/10.jpg)
10
![Page 11: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/11.jpg)
11
Public Safety ~ Recalls Adverse Effect Recall Classification
Class I Class II Class III
Reports of adverse reaction
Manufact. Agrees
Patients contacted
Publicly listed
![Page 12: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/12.jpg)
12
LABELING Legend Drugs Over-the-counter(OTC)
Prescription ONLY Legend Statement
‘Federal law prohibits dispensing of this drug without a prescription’
Transfer Warning ‘State or federal law
prohibits the transfer of this drug to any person other than the person to whom it was prescribed’
Prescription is not required Safe,effective Taken w/o medical
supervision Dose low (Why?)
Negligible abuse potential
• Maybe????
![Page 13: Drug law & regulations](https://reader033.vdocuments.us/reader033/viewer/2022051109/548c1cb8b47959382b8b48bd/html5/thumbnails/13.jpg)
13
California State Board of Pharmacy
Over site agency Consumer Affairs Department Licensure Requirements Board Inspections Disciplinary action www.pharmacy.ca.gov