Term
| Food and Drug Act of 1906 |
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Definition
| Adulterated and misbranded |
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Term
| Food Drug and Cosmetic Act 1938 |
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Definition
| Basis for 1939 Dangerous Drug Act in Ga. Drugs must be proven SAFE |
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Term
| Durham-Humphrey Amendment 1951 |
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Definition
Separated drugs into 2 categories (rx and otc)
- "Caution: Federal law prohibits dispensing without prescription." |
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Term
| Kefauver-Harris Amendment 1962 |
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Definition
| Provide substantial evidence of effectiveness for the product's intended use. |
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Term
| Prescription Drug Marketing Act |
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Definition
| Prohibits re importation of a drug into U.S. by anyone except the manufacturer. |
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Term
| Omnibus Budget Reconciliation Act 1990 |
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Definition
| Required manufacturers provided lowest price to any customer or medicaid patient. Also required offer to counsel for patients. |
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Term
| FDA Modernization Act 1997 |
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Definition
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Term
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Definition
Must have truthful info of a Pharmacists physical location and license number
Cannot dispense controlled substances via internet without a valid prescription issued for a legitimate medical purpose |
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Term
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Definition
Violations of the act committed by online pharmacies outside their states.
- Haight Act |
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Term
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Definition
No one should prescribe or order to dispense a controlled substance except
- licensed or authorizers by Ga to prescribe controlled substances
- For a legitimate medical purpose
- Professional practice |
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Term
| Georgia Regulation 480-27-.02 |
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Definition
Prescription Drug order requirements
- Date
- Name and address of patient or location of an institution
- Name and address of prescriber, telephone, and NPI assigned under federal law
- DEA registration number of prescriber for controlled substance
- Name, strength and dosage quanity
- Number of authorized refills
- Directions
- Written drug order
- Electronic prescription must include all of the requirements except for a signature which must be an electronic signature with the time and date |
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Term
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Definition
| Electronic signature is OK |
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Term
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Definition
| Electronic signature is NOT ACCEPTABLE |
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Term
| Signatures: Law 16-13-21 Code Section |
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Definition
- Prescriptions must have signature of prescribing practioner
- PA's and practice nurse must comply with applicable law regarding signatures
- Physically applied stamp is NOT allowed in replacement of original signature |
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Term
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Definition
- name of the individual making the transmission and the date, time, and location of the origin of the transmission must be recorded on the prescription
- No one other than the practitioner or an agent authorized by the practitioner
- Institutional settings, the name of the individual making the transmission is not required |
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Term
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Definition
NO C2 for APRN and NO expiration DATES
- No refills on dangerous drugs drugs over 12 months |
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Term
| Obligation to fill prescription |
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Definition
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Term
| Regulation 480-22.12 for PA |
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Definition
| Title 16 and Title 43/Chapter 13 are a LAW |
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Term
| Regulation 480-22-.12 for APRN |
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Definition
| Who in good faith fills a prescription drug order presented by a patient |
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