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MPJE review
CH8: Compounding rules/laws
| Question | Answer |
|---|---|
| Should Texas MPJE questions on nonsterile compounding be answered according to USP <795> or Texas rules? | Texas rules. The Texas rule is similar to USP <795> but contains differences. |
| In what pharmacy classes may nonsterile preparations be compounded pursuant to a prescription or medication order? | Class A, C, and E |
| May a Class A pharmacy compound a reasonable quantity of a nonsterile preparation for office use by a practitioner? | Yes, subject to the applicable Texas requirements. |
| May a Class C pharmacy compound a reasonable quantity of a nonsterile preparation for practitioner office use? | Yes |
| May a Class E pharmacy compound a reasonable quantity of a nonsterile preparation for practitioner office use? | Yes |
| May a Class A pharmacy compound nonsterile preparations for distribution to a Class C pharmacy? | Yes |
| May a Class C pharmacy compound nonsterile preparations and distribute them to other Class C pharmacies *under common ownership*? | Yes |
| May a pharmacy compound nonsterile preparations in anticipation of future prescriptions? | Yes, when based on routine, regularly observed prescribing patterns. |
| Does anticipation compounding permit a pharmacy to manufacture unlimited quantities without patient-specific demand? | No. It must be based on routine, regularly observed prescribing patterns. |
| When may a commercially available product be compounded? | ONLY when it is not reasonably available through normal distribution channels in a timely manner, the pharmacy documents this, and the prescriber requests compounding for another dose or dosage form. *it CANT be a blatant copy of the commercial product* |
| What is an exception to the prohibition against compounding an essentially commercially available product? | When the prescriber specifically orders a different strength or dosage form and specifies why the patient needs the compounded product. |
| If a commercially available tablet is 10 mg and the prescriber simply asks the pharmacy to compound essentially the same 10-mg product without a patient-specific reason, is that generally allowed? | No, it cant be basically a copy of the commercial product |
| If a patient requires a strength or dosage form not commercially available and the prescriber documents the need, may the pharmacy compound it? | Yes |
| May one pharmacy contract to compound and dispense for another pharmacy? | Yes, if it complies with the centralized prescription dispensing rule. |
| Who must be initially trained and qualified in nonsterile compounding? | All personnel who compound or directly oversee nonsterile compounding. |
| What training is needed for nonsterile compounding personnel? | Hand-hygiene, garbing, cleaning/sterilizing, handling/transportation, measuring/mixing, proper use of compounding devices, and making compounding records |
| Who has overall responsibility for ensuring that nonsterile compounding personnel have adequate education, training, and proficiency? | PIC |
| May the PIC designate another person to be responsible and accountable for certain compounding operations? | Yes, but that person must be designated by the facilities SOP |
| Who must inspect and approve all components used in compounding? | A pharmacist |
| Who must inspect the compounding record for a product and the final check? | A pharmacist |
| Can techs do non-sterile compounding? What about trainees? | Yes, both can with appropriate training and direct pharmacist supervision |
| May a compounding pharmacy advertise that it provides nonsterile compounding services? Can it include specific drug classes/product names? | Yes and yes |
| May a pharmacy compound veterinary preparations for food-producing animals without regard to federal requirements? | No, need to follow federal guidelines for products for food-producing animals |
| What default BUD applies to a flavored prescription under this Texas provision? | No longer than 14 days when refrigerated, unless otherwise documented. |
| May a pharmacist simply flavor an OTC product at the patient's request? | NO, it needs a prescription from a provider to provide flavoring for the OTC product, this does NOT apply to Rx preparations |
| Does a nonsterile compounding pharmacy have to have a library? | Yes, must include a copy of USP 795, either electronic or hard copy |
| How frequently must surfaces in nonsterile compounding areas be cleaned and sanitized? | On a regular basis according to the facility's SOPs. |
| If a compounded preparation requires weighing a component, what type of balance must the pharmacy have? | A Class A prescription balance or analytical balance and weights. |
| How often must the accuracy of the compounding balance be verified by the pharmacy? | At least every 12 months, as specified in the SOPs. |
| Must balance calibration and verification be documented? | YES |
| When must compounding equipment be cleaned and sanitized? | Before AND after EACH use |
| Must the assessment regarding use of containment engineering controls be documented? | Yes |
| If a containment ventilated enclosure or biological safety cabinet is used, how often must it generally be certified? | At least every 12 months, or according to manufacturer specifications. |
| In addition to ordinary prescription-label information, what must a compounded prescription label identify? | The name(s) of the principal active ingredient(s). Also must say that the preparation was compounded by the pharmacy |
| Must the compounded prescription label include a beyond-use date? | Yes, obviously |
| When no specific stability information applies, what primarily determines the maximum BUD for a nonsterile compound? | Whether the dosage form is aqueous or nonaqueous, whether an aqueous product is preserved, and the applicable storage conditions. |
| Under this rule, what water activity defines an aqueous dosage form? | aᵥ ≥ 0.6. |
| What water activity defines a nonaqueous dosage form? | aᵥ < 0.6. |
| What is the maximum default BUD for a non-preserved aqueous dosage form? | 14 days and MUST be in fridge |
| What is the maximum default BUD for a preserved aqueous dosage form? | 35 days, and can be in fridge or at room temp |
| What is the maximum default BUD for a nonaqueous ORAL liquid? | 90 days at room temp or fridge |
| What is the maximum default BUD for a nonaqueous NON-oral liquid? | 180 days at room temp or fridge |
| Can the BUD of a compounded preparation extend beyond the earliest expiration date of a commercially available starting component? | No |
| If one starting ingredient expires in 20 days but the normal default BUD would be 90 days, what is the maximum BUD? | 20 days, the BUD should reflect when the first ingredient expires |
| May a default BUD be extended when valid scientific stability information supports a longer BUD for that specific compound? | Yes |
| If a USP/NF compounded-preparation monograph specifies a BUD, may the compound exceed it simply because the generic Texas default is longer? | No. The BUD cannot exceed that specified in the monograph. |
| Must a compounding pharmacy have a documented quality-assurance and quality-control program? | Yes |
| Who must develop and approve the Master Formulation Record? | A pharmacist |
| Is a Master Formulation Record required for compounded preparations? | Yes |
| Is a Compounding Record required for each preparation? | Yes |
| What ingredient information must be documented in the Compounding Record? | Identity of ALL components and their corresponding amounts, concentrations, or volumes. |
| What identifying information about each component must be included for the compounding record? | Lot number and expiration date, plus manufacturer/distributor or suitable identifying number. |
| Must container specifications be recorded in the Compounding Record? | YES |
| Must the compounded product receive a unique lot or control number? | Yes |
| Whose names or signatures must appear on the Compounding Record? | The person(s) involved in preparation and the responsible pharmacist, using name, initials, or electronic signature as permitted. |
| Must finished-product evaluation/testing information be included when applicable? | Yes |
| When appropriate, must actual yield be compared with anticipated or theoretical yield? | Yes |
| What is required before office use compounding is allowed? | physicians, vets, and class C pharmacies all require a written agreement with the supplying pharmacy and record keeping |
| What labeling requirements are needed for office-use compounded products? | Must state "compounded product - not for resale" or "for office use only" |
| Which rule governs texas non-sterile compounding? | TSBP 291.131 |
| If texas law for compounding differs with USP 795 or 797, which would you follow? | TEXAS law |
| If a Rx product is flavored for a patient, what is the automatic BUD? | Default 14 days in fridge unless otherwise documented |
Created by:
cdaughtry