Poison Prevention Packaging Act- place ORAL (only) Rx meds in child-resistant safety containers. What are the exceptions?
- Nitroglycerin SL tab
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... [Show More] Erythromycin ethylsuccinate granules for oral suspension
- colestipol powder (Colestid- BAS)
- oral contraceptives in manufacturer's memory-aid dispenser packages
- Doctor or patient may request a non-complying container (keep documentation if that occurs)
erythromycin oral counseling
Base, PCE or stearate dosage forms should be taken on an empty stomach
Ethylsuccinate (E.E.S. Granules) or delayed-release (Ery-Tab) admin without regard to meals--> May consider administering after food to decrease GI discomfort.
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DEA Form 222
Ordering of Schedule I & II C.S requires DEA Form 222
- keep record for 3 YEARs
- Pharmacies can sell to other pharmacies or to prescribers with DEA 222 form (C I & II) --> can sell MAX 5% of their C.S dispensing
(ie. can sell 1,000 to another pharmacy if dispense 20,000 C.Subs)
- Valid for up to 60 days
- The reverse distributor issues DEA Form 222 for C.S. II.
Transfer of Schedule II C.S
Schedule II C.S canNOT be transferred (DEA Form 222 is NOT used to transfer prescriptions)
Filing of prescriptions
Schedule III, IV, or V C.S prescriptions REQUIRE a 1-inch red 'C' on lower right corner if filed along with NON-scheduled prescriptions
- does not apply for electronic filing systems
- EXCEPTION: Schedule II C.S prescriptions MUST be filed separately
Paper or electronic C.S prescription records must be kept for:
- Federal: 2 years
- CA: 3 years
- When there's a conflict between a federal and a state statute, the federal statute outweighs the state statute or regulation, unless the state law is more stringent and, thus, mandates over the less stringent federal rule.
Refill PRN (non-scheduled drugs)
valid for 1 year from the date prescription was written
CA Continuing Education Requirements
- 30 hours CE/2 years
- 2 of the 30 CE hours MUST be law & ethics from a course provided by the Board
- retain CE certificates for 4 years
REMS (Risk Evaluation and Mitigation Strategies)
- required by the FDA for some drugs
- developed by manufacturer and approved by FDA to ensure benefits outweigh risks, ensure appropriate prescribing and minimize patient risk
Recalls, Market Withdrawals, & Safety Alerts
Recall: remove a product from market by a firm's own initiative, FDA request/order
- Class I recall: reasonable probability of serious adverse health consequences/death
- Class II: may cause temporary/reversible S.E; probability of serious consequence is remote
- Class III: not likely to cause adverse health consequences
- Market withdrawal: firm removes the product from market and/or corrects minor violation
- Medical device safety alert: unreasonable risk of substantial harm (in some cases, these situations also considered recall)
Board must be notified within...
- 30 days: change of ownership, address or name/PIC/pharmacy permit, theft/diversion/drug loss
- 14 days: licensed employee is found chemically/mentally/physically impaired
- Controlled substances: losses must be reported to the Board no later than 30 days (notify DEA immediately) --> if the cause is theft, diversion or self-use, loss must be reported within 14 days
- Immediately: bankruptcy/insolvency/receivership
Transfer of drugs notice
upon closure of a pharmacy, notice must be provided to the Board within 10 days (in writing)
- 'Closed-Down' pharmacy= pharmacy no longer engaged in ordinary activity for at least 1 day/week during any 120 day period
- Board may issue a temporary permit for 180 days during a transfer of ownership in order for that pharmacy to continue its operations [Show Less]