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MPJE Ch. 8
Compounding Laws and Rules
| Question | Answer |
|---|---|
| In order to compound commercially available products, they must not be _____ _______ from normal distribution channels in a timely manner and the prescribing practitioner has requested that the drug be _________ | commercially available; compounded |
| A pharmacy cannot compound preparations that are essentially ____ of commercially available products (i.e. slightly varying strength) unless the prescribing practitioner specifically orders the ______ or dosage form and specifies why the pt needs the product compounded | copies; stength |
| Compounding pharmacies/pharmacists may ______ and ____ the fact that they provide non-sterile prescription compounding services, which may include specific drug products and classes of drugs | advertise; promote |
| A pharmacy may not compound veterinary preparations for use in _____ _______ animals except in accordance with federal guidelines | Food producing |
| If adding FLAVOR to a prescription, it must be labeled with a BUD no longer than ___ days if stored in the fridge unless otherwise documented. May not add flavoring to a _____ product at the request of the pt unless the pharmacist obtains a prescription for the OTC | 14; OTC |
| Required library for compounding pharmacies: In addition to the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard copy or electronic format of chapter ___ of the USP/NF | 795 |
| Compounding pharmacies shall have a Class A prescription balance shall be calibrated and have accuracy verified by a pharmacist at least every ___ months as specified in the pharmacy's SOP | 12 |
| If a containment ventilated enclosure or BSC is used, it shall be certified at least every ___ months or according to manufacturer specifications | 12 |
| Compounded prescription label along with normal labeling requirements must include: | - name(s) of principal active ingredients of the compounded preparation - statement that the preparation has been compounded by the pharmacy and a BUD after which the compounded preparation should not be used *BUD determined as outlined in USP/NF 795 |
| Examples of nonaqueous dosage forms include ___, ____, and _____ | tablets, suppositories, and ointments |
| Examples of aqueous dosage forms include __ ____ and _____, ____, and _____ | oral solutions, and suspensions, lotions, andcreams |
| What is the definition of an aqueous dosage form? | is one that has a water activity equal to or greater than 0.6 (i.e., emulsions, gels, creams, solutions, sprays, or suspensions) |
| BUD of non-preserved aqueous dosage forms are? | not later than 14 days when stored in a fridge |
| BUD of preserved aqueous dosage forms are? | not later than 35 days when stored at controlled room temp or in a fridge |
| What is the definition of a nonaqueous dosage form? | is one that has a water activity less than 0.6 |
| BUD of nonaqueous oral liquids are? | not later than 90 days when stored at controlled room temp or in a fridge |
| BUD of other nonaqueous dosage forms are? | not later than 180 days when stored at controlled room temp or fridge |
| Examples of other nonaqueous dosage forms that have a water activity of less than 0.6 include? | capsules, tablets, granules, powders, nonaqueous topicals, suppositories, and troches or lozenges |
| BUD limits may be exceeded when supported by valid ____ ______ info for the specific compounded preparation | scientific stability |
| What is a master formulation record? | the recipe for the product and includes things such as the formula, components, and compounding directions. *shall be developed and approved by a pharmacist for all compounded preparations |
| what is a compounding record? | - components; amounts, conc.; volumes - lot number; exp. date of each componenet - manufac.; distributor - container specs. - unique lot or control # - BUD - Date of preparation - name, initials, or e-sig of preparer/ pharmacist - evaluation and testing specs. - comparison of yield to anticipated and theoretical yield, when applicable |
| Office-use compounding for distribution to physician, Class C pharmacies, or veterinarians require written agreement along with record-keeping requirements, recall procedures and products that must be labled as: | For institutional or Office Use Only-- Not for Resale or Compounded Product *provisions for office use compounding in the TX Pharmacy Act should be read with the federal law on compounding inclduing Section 503A and 503B of the FDCA |
| TSBP rule 291.133 is the Texas rule governing the compounding of _____ _____ | Sterile preparations |
| USP 800 details practice and quality standards for handling ____ ______ in various healthcare settings from receipt, storage, compounding, dispensing, administration, and disposal | hazardous drugs |
| The ____ ____ _ _____ ___ and ___ (NIOSH) maintains a list of hazardous drugs and antineoplastic agents used in healthcare | National Institute of Occupational Safety and Health |
| USP 825 details minimum practice and quality standards for handling __________. It discusses the handling in settings such as a nuclear pharamcies and nuclear medicine departments in hospitals and other healthcare settings | radiopharmaceuticals |
| USP 825 applies to all individuals who prepare radiopharmaceuticals including _____ ____ _____ (ANP), ___ ___(AU), ____, and individuals who work under their supervision | authorized nuclear pharmacists; Authorized Users; physicians |
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Xander635
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