Operational Standards: §291.74 a. How should a Class C pharmacy handle prescript

Question

Operational Standards: §291.74
a. How should a Class C pharmacy handle prescription drug samples?
b. What are the proper storage ranges (oC & oF) for Cold, Refrigerator, Freezer, Cool, Rm Temp, Warm, and excessive Heat?
c. How does a Class C Pharmacy handle drugs that are expired, outdated, &/or unusable?
d. In what quantities can a Class C pharmacy pre-package drugs? Operational Standards: §291.74
a. How should a Class C pharmacy handle prescription drug samples?
b. What are the proper storage ranges (oC & oF) for Cold, Refrigerator, Freezer, Cool, Rm Temp, Warm, and excessive Heat?
c. How does a Class C Pharmacy handle drugs that are expired, outdated, &/or unusable?
d. In what quantities can a Class C pharmacy pre-package drugs? Operational Standards: §291.74
Operational Standards: §291.74
a. How should a Class C pharmacy handle prescription drug samples?
b. What are the proper storage ranges (oC & oF) for Cold, Refrigerator, Freezer, Cool, Rm Temp, Warm, and excessive Heat?
c. How does a Class C Pharmacy handle drugs that are expired, outdated, &/or unusable?
d. In what quantities can a Class C pharmacy pre-package drugs?

Explanation / Answer

ANS 1) Operation of a pharmacy located in a freestanding ambulatory surgical center that is licensed by the Texas Department of State Health Services. Class C pharmacies located in a freestanding ambulatory surgical center shall comply with this section, in lieu of §§291.71 - 291.75 of this title (19) Prescription drug-- (A) A substance for which federal or state law requires a prescription before it may be legally dispensed to the public;

(B) A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements:

(i) Caution: federal law prohibits dispensing without prescription or "Rx only" or another legend that complies with federal law; or

(ii) Caution: federal law restricts this drug to use by or on order of a licensed veterinarian; or

(C) A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only.

ANS 2) The U.S. Food and Drug Administration (FDA) recommends the following for refrigerated and food storage.Keep the refrigerator temperature at or below 40° F (4° C). The freezer temperature should be 0° F (-18° C).

Stick to the "two-hour rule" for leaving items needing refrigeration out at room temperature. Never allow meat, poultry, seafood, eggs, or produce or other foods that require refrigeration to sit at room temperature for more than two hours, one hour if the air temperature is above 90° F (32° C).

ANS C)The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer.

out dated drugs or unstable drugs are first analysed in labs as per FDA SPECIFICATIONS . The batch numbers & the year of manufacturing & the year of expiry is noted . th COA certificate of analaysis is preserved & intimation is send to FDA & mentioned that the the out dated drug labelled by the FDA is being destroyed ( Means that the out dated drug is incernated ( burnt) the residual is again sent for analysis The record is preserved fpr aperiod of 3 years.

ANS 4) Refills. Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.

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