Extemporaneous Compounding PDF
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This document outlines extemporaneous compounding, highlighting guidelines for distinguishing between compounding and manufacturing, compounding facilities, personnel, duties, ingredient standards, and the compounding process. It also covers packaging, storage, and labeling procedures.
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MODULE 3 c ompoundeduse-bydate,andname,strength,andquantityof activeingredients....
MODULE 3 c ompoundeduse-bydate,andname,strength,andquantityof activeingredients.Anexceptiontothismaybetheoutsourcing EXTEMPORANEOUS COMPOUNDING of some compounded preparations by hospitals to contract OUTLINE compounding pharmacies Compounding Compounding Facilities and Equipment Guidelines for distinguishing between compounding and manufacturing P harmacies that engage in compounding should have a Compounding Facilities and Equipment designatedareawithadequatespacefortheorderlyplacement Personnel of the equipment and materials used in compounding activities. Duties Thepharmacistisalsoresponsibleforthepropermaintenance, Ingredient Standards cleanliness, and use of all equipment involved in the Compounding Process compounding practice. Packaging, Storage and Labeling Personnel XTEMPORANEOUS COMPOUNDING E O nly personnel authorized by the responsible pharmacist Preparation(mixing, assembling, altering, packaging,and should be in the immediate vicinity of the drug-compounding labeling of a drug, drug-delivery device)of drugproduct operation. According to the licensed practitioner’sprescriptionand Any person with an apparent illnessoropenlesionshouldbe medication order,to meet the unique individual patient’sneed excludedfromdirectcontactwithcomponents,drugpreparation ompounding includes the following: C containers, closures, in-process materials, and drug Preparation ofdrug dosage formsfor both human andanimal preparations until the condition is corrected by competent patients, medical personnel. Preparation ofdrugs or devicesin anticipation ofprescription Allpersonnelwhoassistincompoundingproceduresshouldbe drug orders, based on routine, regularly observed prescribing instructed to report to the responsible pharmacist any health patterns, conditions that may have an adverse effect on drug Reconstitution or manipulation of commercial productsthat may preparations. require the addition of one or more ingredients ❖Preparation of paper tablets: e.g.Spironolactone(Aldactone; Duties mineralocorticoid receptor antagonist; tx high blood pressure he pharmacist has the responsibility and authority: T and heart failure) → Dr’s orders: 5mg paper tabs To inspect and approve or reject all components, drug → Commercially available: 50mg tablet preparation containers, closures, in-process materials, and Preparation of drugs or devices for the purposes of, or as an labeling. incident to, research (clinical or academic), teaching, or Toprepareandreviewallcompoundingrecordstoensurethat chemical analysis, and preparation of drugs and devices for no errors have occurredin the compounding process. prescriber’s office use where it is permitted by the law. In addition to compounding, the pharmacist provides other ervices, such as the following: s Manufacturing Publicizes the availability of both prescription and The production, preparation, propagation, conversion, and/or nonprescription compounding services. These services may processing of a drug or device, either directly or indirectly, include chemicals, devices, and alternative dosage forms, through extraction from substances of natural origin or Provides drug searches on specific chemicals in different independently through means of chemical or biological dosageforms,strengths,bases,andtheliketoaccommodate synthesis;. physicians’ specific needs, The term includes any packaging or repacking of the Provides follow-up information in response to apractitioner’s substance(s) or labeling or relabeling of its container and the request for information regarding a compounded medication, promotion and marketing of such drugs or devices. and Manufacturing also includes the preparation and promotion of Consult with practitioners regarding a particular dosage form commerciallyavailableproductsfrombulkcompoundsforresale when discussing services with a health care provider. by pharmacies. Duties uidelines for distinguishing G P harmacists should possess the education, training, and between compounding and manufacturing proficiency necessary to properly and safely perform P harmacists may compound drugs in limited quantities compounding dutiesat the level at which they areinvolved. prior to receiving a valid prescription, on the basis of a All pharmacists who engage in the compounding of drugs history of receiving valid prescriptions that have been shouldbeproficientincompoundingandshouldmaintainthat generated solely within an established proficiency throughcurrent awareness and training. pharmacist–patient–prescriber relationship, provided that the Instruction for compounding pharmacists should cover the prescriptions are maintained on file for all such preparations f ollowing: dispensed at the pharmacy. Proper use of compounding equipment Pharmacistsshouldnotoffercompoundedmedicationsto Pharmaceutical techniques needed to prepare compounded other pharmacies for resale; however, a practitioner may dosage forms obtaincompoundedmedicationtoadministertopatients,butit Properties of dosage forms to be compounded and related shouldbelabeledwiththefollowing:“ForOfficeUseOnly,”date factors,suchasstability,storageconsiderations,andhandling General Steps in the Compounding Process rocedures. p REPARATORY P Literature regarding stability, solubility, and other 1. Judging thesuitability of the prescriptionin termsof its safety physicochemical properties of the ingredients and intended use and the dose for the patient. Handling of nonhazardous and hazardous materials in the 2. Performing thecalculationsto determine the quantitiesof the work area, including protective measures for avoiding ingredients needed. exposure, emergency procedures to follow in the event of 3. Selecting theproper equipmentand making sure itis clean. exposure, and the location of Material Safety Data Sheets 4. Donning theproper attire and washing hands. (MSDSs)in the facility. 5. Cleaningthe compounding area and the equipment, if Use and interpretation of chemical and pharmaceutical necessary. symbols and abbreviations in medication orders and in 6. Assemblingall the necessary materials and ingredientsto formulation directions. compound and package the prescription. Review of pharmaceutical calculations. COMPOUNDING 7. Compounding the prescriptionaccording to the formulary Attire record or the prescription, using techniques accordingto the P ersonnelengagedinthecompoundingofdrugsshouldwear art and science of pharmacy. clean clothing appropriateto the operation beingperformed. FINAL CHECK Protective apparel should be worn as necessary to protect 8. Checkingas indicated, the weight variation, adequacyof drug preparations from contamination. mixing, clarity, odor, color, consistency, and pH. A clean laboratory jacket usually is considered appropriate 9. Entering the information in thecompounding log. attirefor nonsterile compounding procedures. 10.Labelingthe preparation. Working with hazardous materials may require the use of SIGN-OFF goggles,gloves,masksorrespirators,doublegowns,andfoot 11.Signing and datingthe prescription, affirming thatall of the covers; showers and eyewash stationsshould be provided. indicated procedures were carried out to ensure uniformity, identity, strength, quantity, and purity. Ingredient Standards CLEAN-UP Grade Description 12.Cleaning and storing all equipment. 13.Cleaning the compounding area. eets the minimum purity standards; M conforms to tolerances set by theUnited Continuous Quality Improvement USP/NF States Pharmacopeia/National Formulary spects to be reviewed include the following: A for contaminants dangerous to health Appropriate ingredients, adjuvants, and equipment were igh purity; conforms to minimum H selected for the specific preparation. specifications set by the Reagent Calculationsare correct. ACS reagent Measurements were performed accurately with properly Chemicals Committee of theAmerican Chemical Society functioning equipment. The formulation is appropriate for the intended use and ore refined than technical or commercial M stability limits of the preparation. CP (chemically pure) grade but still of unknown quality Packaging, Storage, and Labeling echnical or T Indeterminate quality T he pharmacist should inspect and approve all components, commercial drug preparation containers, closures, labeling, and other Compounding Process materials involved in the compounding process. These materials should be handled and stored in a manner Before the first step in the compounding process is taken, that willprevent contamination. t he following questions must be considered: Packaging What are the physicalandchemicalpropertiesandmedicinal and pharmaceutical usesof the drug substance? T o help maintain the potency of the stored drug, packaging Are the quantity and quality of each active ingredient materials should not interactphysicallyorchemicallywiththe identifiable? preparation. Giventhepurposeoftheprescription,willthepreparationand Container characteristics of concern include inertness, route of administration provide adequate absorption, either visibility, strength, rigidity, moisture protection, ease of locally or systemically? re-closure, and economy of packaging. Are excipients present from any source (manufactured Plasticcontainershavebecomeincreasinglypopularbecause products) thatmaybeexpectedtocauseanallergicreaction, theyarelessexpensiveandlighterinweightthanglass.Only irritation, toxicity, or an undesirable organoleptic responseby plastic containers that meet USP 34/NF29standardsshould the patient? be used. For preparations that are to be administered orally, are the activeingredientsstableinthenormalgastricpHrange,orare they subject toextensive hepatic first-pass metabolism? Packaging Stability, Expiration, and Beyond-Use Dating Ingeneral,compoundingchemicalsshouldbestoredintightly theextenttowhichadosageformretains,within closed, light resistant containers at room temperature; some specifiedlimits&throughoutitsperiodofstorage chemicals, however, requirerefrigeration. Stability anduse,thesamepropertiesandcharacteristics Chemicalsshouldbestoredoffthefloor,preferablyonshelves that it possessed at the time of its preparation. in a clean, dry environment. isadateplacedonaprescriptionbyaPharmacy Commercial drugs to be used in the compounding process notingwhentheprescriptionshouldnolongerbe should be removed from cartons and boxes before they are used. stored in the compounding area. Thedatewhentheprescriptionshouldnolonger Temperature requirements for the storage of substances are be used. detailed in the appropriateUSP 34/NF 29 monographs. Beyond-use Determined by the pharmacy when they fill a The temperaturesofthestorageareas,includingrefrigerators Date prescription. and freezers, should be monitored and recorded at least Basedonthetypeofdrug,howfastitdegrades, weekly. dosage, type of container, storage conditions, Flammable or hazardous products should be stored prescription length, the likelihood of appropriatelyinsafetystoragecabinetsandcontainers,which contamination. are available from many laboratory suppliers. this is a point at which a manufacturer can no Labeling longer guarantee the strength or safety of the Labeling should be done according to state and federal medication. r egulations. Usually, labeling information includes the: Thedateatwhichamanufacturercannolonger 1.generic or chemical names of the active ingredients, Expiration guarantee the strength or safetyof a medication. 2.strength or quantity, Date Determined by the US Food and Drug 3.pharmacy lot number, Administration. 4.beyond-use date, and Based on testing a drug in specific conditions 5.any special storage requirements related to storage containers, lighting, temperature, etc. Whenacommercialdrugproducthasbeenusedasasource of the drug, the generic name of the drug product, not the RECORDS AND REPORTS proprietary name,should be placed on the label. Inactive ingredients and vehiclesshouldalsobelistedonthe harmacists should maintain at leastfour setsofrecords for P label. compounding: Monitoring expiration dates will ensure that materials, 1.Formulation records, ingredients,andsuppliesarerotatedsothattheoldeststockis 2.Compounding records, used first. 3.SOPs, including equipment, maintenance records, and ❖Ifthereisnoexpirationdateprovided,asystemofmonitoring 4.Ingredients records, including certificates of analysis and shouldbeestablished.Example,placingthedateofthereceipt MSDSs. of the materials on the labels. Patient Counseling For Compounded preparations, labelling should include: Compounded prescriptions offer an excellent opportunity for 1.complete list of ingredients, patient counseling. 2.preparation date, The pharmacist canexplainthattheparticularprescriptionhas 3.assigned beyond-use date, beenpreparedespeciallyforthepatientandcandescribesteps 4.appropriate testing/ published data, and that are required before its administration. 5.control numbers This occasion can also be used to discuss other routine Quality Control subjects with the patient. T he pharmacist should review all compounding records for Disposing of Expired Chemicals and Medications accuracy and conduct in-process and final checks to ensure When disposing of pharmaceutical waste, pharmacists must that errors have not occurredin the compounding process. complywithallpertinentstateandfederalregulationsaccording Written procedures for the compounding of drugs should be to theU.S. Environmental Protection Agency (EPA). available andfollowedtoensuretheidentity,strength,quality, → equivalent to the DENR and purity of the finished preparation. Specific chemicals are listed as hazardous waste in the Ingredients should be accurately weighed, measured, or Resource Conservation and Recovery Act (RCRA). subdivided as indicated. Thecompoundingpharmacistshouldcheckandrecheckthese operationsateachstepinthecompoundingprocesstoensure that weights or measures are correct. Standard operating procedures (SOPs) should be prepared thatdescribethetestsorexaminationstobeconductedonthe finished preparation.
