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established that pharmacies compounding only "patient-specific" preparations made in response to a prescription (503A pharmacies) cannot be required to obtain FDA approval for such products, as they will remain exclusively under state-level pharmacy regulation. At the same time, section 503B of the law regulates "outsourcing facilities" which conduct bulk compounding or are used as outsourcing for compounding by other pharmacies. These outsourcing facilities can be explicitly authorized by the Food and Drug
Administration under specified circumstances, while being exempted from certain requirements otherwise imposed on mass-producers. In any pharmacy, compounding is not permitted for a drug product that is "essentially a copy" of a mass-produced drug product, however outsourcing pharmacies are subject to a broader definition of "essentially a copy". For traditional/patient-specific compounding, 503A's definition of "copy" retains its original focus on drug
623:
of oversight. "Non-traditional" compounders behave like drug manufacturers in some cases by having sales teams that market non-personalized drug products or production capability to doctors, by making drugs that are essentially the same as commercially available mass-produced drug products, or by preparing large batches of a given drug product in anticipation of additional prescriptions before actually receiving them. An FDA spokesperson stated, "The methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies. Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship." The head of the FDA has recently requested the following authority from
Congress:
414:
be used, but the environment in which the hood is located must be strictly controlled for microbial and particulate contamination and all procedures, equipment and personnel must be validated to ensure the safe preparation of sterile products. In non-sterile compounding, a powder containment hood is required when any hazardous material (e.g. hormones) are prepared or when there is a risk of cross-contamination of the compounded product. Pharmacists preparing compounded products must comply with these requirements and others published in the
Australian Pharmaceutical Formulary & Handbook.
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27:
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to prepare more complex products. Although pharmacists who have undertaken further training to do complex compounding are not yet easily identified, the Board has been working to put a credentialing system in place. In 2011 the
Pharmacy Board convened a Compounding Working Party to advise on revised compounding standards. Draft compounding guidelines for comment were released in April 2014. Pharmacists must comply with current guidelines or may be sanctioned by the Board.
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360:(ISMP) has expressed concern with manual methods, particularly the error-prone nature of the syringe pull-back method of verifying sterile preparations. To increase accuracy, some U.S. hospitals have adopted IV workflow management systems and robotic compounding systems. These technologies use barcode scanning to identify each ingredient and
526:
random testing, significant problems have been found. Random tests by the state's pharmacy board over the last several years have found that as many as one in four compounded drugs was either too weak or too strong. In
Missouri, the only other state that does testing, potency varied by as much as 300 percent.
571:
tied to the New
England Compounding Center, a pharmacy which engaged in bulk compounding. At that time it was also disclosed that the United States and Massachusetts state health regulators were aware in 2002 that steroid treatments from the New England Compounding Center could cause adverse patient
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Both sterile and non-sterile compounding are legal provided the compounding is done for therapeutic use in a particular patient, and the compounded product is supplied on or from the compounding pharmacy. There are additional requirements for sterile compounding. Not only must a laminar flow cabinet
409:
In
Australia the Pharmacy Board of Australia is responsible for registration of pharmacists and professional practice including compounding. Although almost all pharmacies are able to prepare at least simple compounded medicines, some pharmacy staff undertake further training and education to be able
54:
a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity
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The FDA, among others, claims that larger compounding pharmacies act like drug manufacturers and yet circumvent FDA regulations under the banner of compounding. Drugs from compounding pharmacies can be cheaper or alleviate shortages, but can pose greater risk of contamination due in part to the lack
437:
In the Drug
Quality and Security Act (DQSA) of 2013 (H.R. 3204), Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to clarify limits of FDA jurisdiction over patient-specific compounding, and to provide an optional pathway for "non-traditional" or bulk compounders to operate. The law
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Poor practices on the part of drug compounders can result in contamination of products, or products that do not meet their stated strength, purity, or quality. Unless a complaint is filed or a patient is harmed, drugs made by compounders are seldom tested. In Texas, one of only two states that does
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Veterinary medicine, for a change in dose, change to a more easily administered form (such as from a pill to a liquid or transdermal gel), or to add a flavor more palatable to the animal. In the United States, compounded veterinary medicine must meet the standards set forth in the Animal
Medicinal
364:
weight measurement to confirm the proper dose amount. The workflow management systems incorporate software to guide pharmacy technicians through the process of preparing IV medications. The robotic systems prepare IV syringes and bags in an ISO Class 5 environment, and support sterility and dose
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may not" be patient-specific based on individualized prescriptions. Registered outsourcing facilities, unlike traditional compounding facilities, are subject to the FDA's oversight. In addition to being subjected to Food and Drug
Administration inspections, registration, fees, and specified
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or ultimate dosage forms rather than drug substances or active ingredients, and in any event it explicitly excludes from its definition any compounded drug product that a given patient's prescribing practitioner determines makes a "significant difference" for the patient.
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reactions. It was further disclosed that in 2001–02, four people died, more than a dozen were injured and hundreds exposed after they received back-pain injections tainted with a common fungus dispensed by two compounding pharmacies in California and South Carolina.
426:, compounding pharmacies are licensed and regulated by states. National standards have been created by Pharmacy Compounding Accreditation Board (PCAB), however, obtaining accreditation is not mandatory and inspections for compliance occur only every three years. The
77:
Compounding preparations of a given formulation in advance batches, as opposed to preparation for a specific patient on demand, is known as "non-traditional" compounding and is akin to small-scale manufacturing. Jurisdictions have varying regulations that apply to
50:) is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest (e.g., liquid vs. tablet), or to avoid a
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A physician may choose to prescribe a compounded medication for a patient with an unusual health need that cannot be met with commercially manufactured products. The physician may choose to prescribe a compounded medication for reasons such as
533:, concerned about the rising number of accidents related to compounded medications, identified "red flag" factors and issued a guide devoted to human pharmacy compounding, These factors include instances where pharmacists are:
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Various ideas have been proposed to expand federal US regulation in this area, including laws making it easier to identify misuse or misnomered-use and/or stricter enforcement of the longstanding distinction between
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or crude drugs came the birth of the modern pharmaceutical company. Pharmacists were trained to compound the preparations made by the drug companies, but they could not do it efficiently on a small scale. So
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were familiar with various natural substances and their uses. They compounded a variety of preparations such as medications, dyes, incense, perfumes, ceremonial compounds, preservatives and cosmetics. In the
635:. Some US states have also taken initiatives to strengthen oversight of compounding pharmacies. A major source of opposition to new Food and Drug Administration regulation on compounding is makers of
516:
The label of the drug states that it is a compounded drug, as well as the name of the outsourcing facility, the lot or batch number of the drug, dosage form and strength, and other key information
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were recalled. The hospitals reported affected were Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional. The patients had received intravenous infusions of
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In hospitals, pharmacists and pharmacy technicians often make compounded sterile preparations (CSPs) using manual methods. The error rate for manually compounded sterile IV products is high. The
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The drug is not "essentially a copy" of one or more marketed drugs (as defined uniquely in section 503B, notably more broadly and with narrower exclusions than for "traditional" compounding)
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Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility
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The compounding pharmacist demonstrates that he or she will use controls comparable to the controls applicable under any applicable risk evaluation and mitigation strategy (REMS)
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Other ingredients used in compounding the drug must comply with the standards of the applicable United States Pharmacopeia or National Formulary monograph, if a monograph exists
1441:
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Compounding drugs in advance of receiving prescriptions, except in very limited quantities relating to the amounts of drugs previously compounded based on valid prescriptions
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Michigan Journal of Law Reform » Compounding Reform: Reconsidering the Draft Safe Drug Compounding Act of 2007 in Light of the Ongoing Fungal Meningitis Outbreak
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of the practice of medicine. These new regulations forced the drug companies to prove that any new medication they brought to market was safe. With the discovery of
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Compounding finished drugs from bulk active ingredients that aren't components of FDA-approved drugs, without an FDA-sanctioned, investigational new-drug application
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The FDA weighs the following factors in deciding whether it has authority to "exercise its discretion" to require approval for a custom-compounded drug product:
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The facility does not compound using "bulk drug substances" (unless certain exceptions apply) and its drugs are manufactured by an FDA-registered establishment
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compounding center said that about 750 people were sickened, including 63 deaths, and that infections were linked to more than 17,600 doses of
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483:
The DQSA amended the FFDCA to create a new class of FDA-regulated entities known as "outsourcing facilities" whose compounding activities "may
430:(FDA) has authority to regulate "manufacturing" of pharmaceutical products—which applies when drug products are not made or modified as to be
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1302:
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1266:"Drug Quality and Security Act Gives FDA Authority to Regulate Drug Compounding and Creates Uniform Federal Standards for Distribution"
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hospitals developed bacterial infections. All lots of medications dispensed since May 9, 2013, made by Specialty Compounding, LLC of
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The drug does not appear on the FDA list of drugs or categories of drugs that present "demonstrable difficulties" for compounding
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253:, they separated an active ingredient from the crude preparation, and compounded a medication using this active ingredient.
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in 754. The modern age of pharmacy compounding began in the 19th century with the isolation of various compounds from
55:(e.g. avoiding allergy) to individual optimality (e.g. ideal dose level) to even preference (e.g. flavor or texture).
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Compounding drug products that have been pulled from the market because they were found to be unsafe or ineffective
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pain that were shipped to 23 states. At that time, another incident was reported after at least 15 people at two
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until the early 1950s when the majority of dispensed drugs came directly from the large pharmaceutical companies.
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199:
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Boothby LA, Doering PL (August 2008). "Bioidentical hormone therapy: a panacea that lacks supportive evidence".
804:
802:
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Patients who need drugs that have been discontinued by pharmaceutical manufacturers because of low profitability
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Children who want flavored additives in liquid drugs, usually so that the medication tastes like candy or fruit
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their compounding needs to large-scale compounding pharmacies, particularly of sterile-injectable medications.
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administration, whereas outpatient or community pharmacies typically engage in compounding medications for
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Pharmacies Fought Controls; Industry at the Focus of Meningitis Outbreak Beat Back More Federal Oversight
1137:. Australian Government. Department of Health and Aging. Therapeutic Goods Administration. December 1997
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A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented
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20:
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736:"The valuable contributions of Al-Razi (Rhazes) in the history of pharmacy during the middle ages"
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Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”
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promotion, the drug manufacturing industry came of age. Pharmacists continued to compound most
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Pikesville man joins push for drug oversight reform after meningitis outbreak – Baltimore Sun
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Patients requiring an individualized compounded formulation to be developed by the pharmacist
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Receiving, storing, or using drugs' components not determined to meet compendia requirements
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1432:. Statement of Margraret A. Hamburg, M.D., Commissioner of Food and Drugs, April 16, 2013.
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The drug will not be sold or transferred by an entity other than the outsourcing facility
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During the 1800s, pharmacists specialized in the raising, preparation and compounding of
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administration. Due to the rising cost of compounding and drug shortages, some hospitals
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Please help update this article to reflect recent events or newly available information.
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1037:"ISMP Survey Provides Insights into Pharmacy Sterile Compounding Systems and Practices"
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Compounding drugs that are essentially copies of a commercially available drug product
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into a liquid or transdermal gel for people who cannot swallow pills due to disability
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988:"Observational study of accuracy in compounding i.v. admixtures at five hospitals"
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The drug does not appear on a list published by FDA of unsafe or ineffective drugs
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Compounding drugs that are essentially the same as commercially available products
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Patients requiring limited dosage strengths, such as a very small dose for infants
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Drugs are compounded by or under the direct supervision of a licensed pharmacist
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1156:"International Academy of Compounding Pharmacists: Frequently Asked Questions"
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Failing to conform to applicable state law regulating the practice of pharmacy
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reporting requirements, other requirements of outsourcing facilities include:
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810:"International Academy of Compounding Pharmacists: Definition of Compounding"
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1194:"Text of H.R. 3204: Drug Quality and Security Act (Enrolled Bill version)"
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Receiving, storing, or using drugs not made in an FDA-registered facility
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Journal of the International Society for the History of Islamic Medicine
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879:"Update on Illegal Compounding of Clenbuterol Veterinary Drug Products"
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234:
120: in this section. Unsourced material may be challenged and removed.
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Patients who cannot take commercially prepared prescriptions of a drug
1341:"Health officials knew of problem steroids in 2002: U.S. House panel"
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accuracy by removing human error and contamination from the process.
238:
71:
51:
1391:
Grady, Denise; Pollack, Andrew and Tavernise, Sabrina (2012-10-07).
95:
58:
Hospital pharmacies typically engage in compounding medications for
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National Academies of Sciences, Engineering & Medicine (2020).
434:—regardless of whether this is done at a factory or at a pharmacy.
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Patients who require multiple medications combined in various doses
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1444:. Articles.baltimoresun.com (2012-11-14). Retrieved on 2013-05-13.
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Drug Compounding: FDA Authority and Possible Issues for Congress
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Burtin, T. M.; Grimaldi, J. V. and Martin, T. W. (2012-10-14).
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221:. The pharmacist extracted these drugs using solvents such as
195:
1455:
FDA chief vows to get 'aggressive' with compounding pharmacies
1368:"Texas compounding pharmacy recalls drugs after 15 infections"
307:
Patients requiring a different formulation, such as turning a
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U.S. Concern Over Compounders Predates Outbreak of Meningitis
986:
Flynn, E. A.; Pearson, R. E.; Barker, K. N. (15 April 1997).
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962:"The Benefits of Compounding Sports Meds into a Single Dose"
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Compounding drugs removed from the market for safety reasons
269:. With the turn of the 20th century came greater government
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651:- the ancestral practitioner of compounding, and their shop
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bacteria, which can cause symptoms such as fever and pain.
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Failing to operate in conformance with applicable state law
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developed advanced methods of compounding drugs. The first
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Martin, T. W.; Burton, T. M.; Dooren, J. C. (2012-10-09).
1393:
Scant Oversight of Drug Maker in Fatal Meningitis Outbreak
1305:. Food and Drug Administration. 2012-12-03. Archived from
1217:. National Home Infusion Association. 2010. Archived from
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Using commercial-scale manufacturing or testing equipment
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Proposed Legislative Reforms Addressing Compounded Drugs
657:- Compounding is involved in the surrounding controversy
1518:
217:, are from natural sources and usually contain several
1215:"Compounding Legislation Action Center - Section 503A"
1054:
Leary, Mary-Haston; Eckel, Stephen (January 1, 2018).
617:
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Compounding in anticipation of receiving prescriptions
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Patients facing a supply shortage of their normal drug
265:, not lack of skill or knowledge, produced the modern
241:. They eventually began isolating and identifying the
1329:. Usatoday.com (2012-10-09). Retrieved on 2012-12-19.
1285:
Bogdanich, Walt and Tavernise, Sabrina (2012-10-22).
733:
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Compounding from bulk ingredients not approved by FDA
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Patients who absorb or excrete medications abnormally
1519:
International Journal of Pharmaceutical Compounding
1056:"The Selection Process for IV Workflow Technology"
985:
661:New England Compounding Center meningitis outbreak
563:New England Compounding Center meningitis outbreak
417:
1469:. Mjlr.org (2013-03-17). Retrieved on 2013-05-13.
1093:"Pharmacy Board of Australia Nov 2011 Communique"
783:"Services Overview | Services | Bayview Pharmacy"
82:and pharmacies that do advance bulk compounding.
1894:
1514:International Academy of Compounding Pharmacists
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610:in the blood. Implicated in these cases is the
1327:Meningitis outbreak toll: 119 cases, 11 deaths
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1263:
1242:. Food and Drug Administration. Archived from
902:
699:Hadzović, S (1997). " (Article in Croatian)".
432:tailored in some way to the individual patient
351:
1552:
1132:"Therapeutic goods regulations: Exempt goods"
1107:"Pharmacy Board of Australia - notifications"
871:
755:
753:
1292:
761:"What to Expect from a Compounding Pharmacy"
567:In October 2012 news reports surfaced of an
30:Pharmacist compounding a medication using a
1303:"The Special Risks of Pharmacy Compounding"
1060:Pharmacy Purchasing & Products Magazine
896:
666:Professional Compounding Centers of America
575:In August 2013 further reports tied to the
256:With the isolation of medications from the
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1053:
992:American Journal of Health-System Pharmacy
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368:
1003:
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136:Learn how and when to remove this message
1619:Separation of prescribing and dispensing
1501:. Businessweek. Retrieved on 2013-05-13.
1075:"Allegheny Makes a Case for IV Robotics"
698:
655:Bioidentical hormone replacement therapy
468:Compounding for third parties for resale
343:bioidentical hormone replacement therapy
25:
1457:. latimes.com. Retrieved on 2013-05-13.
1407:"Outbreak Spurs Calls for New Controls"
1072:
1041:Institute For Safe Medication Practices
697:Information taken from the abstract of
691:
557:New England Compounding Center incident
521:Drug testing and reporting of incidents
358:Institute for Safe Medication Practices
1895:
1338:
1183:. Boston.com. Retrieved on 2013-05-13.
1540:
1181:How risky are compounding pharmacies?
1034:
175:were opened by Muslim pharmacists in
1398:
1347:
1264:Michael Werner (November 19, 2013).
1240:"Medical Center Pharmacy v. Mukasey"
1073:Buckley, Bruce (February 16, 2021).
372:
118:adding citations to reliable sources
89:
618:Misuse prompting regulatory changes
338:Drug Use Clarification Act (AMDUCA)
13:
1385:
1339:Morgan, David (October 22, 2012).
586:injections used to treat back and
277:, modern marketing techniques and
16:Preparation of a custom medication
14:
1914:
1532:Federation of American Scientists
1507:
245:in these drug concoctions. Using
1877:
1876:
1837:List of pharmaceutical companies
1196:. GovTrack.us. November 21, 2013
377:
318:medication, such as one without
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1857:Pharmacies in the United States
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855:"Options for thyroid treatment"
418:Regulation in the United States
105:needs additional citations for
1528:Congressional Research Service
1497:Barrett, Paul M. (2012-11-14)
775:
734:Kaf al-Ghazal, Sharif (2004).
727:
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187:. From this came the earliest
1:
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569:outbreak of fungal meningitis
183:for the purpose of producing
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917:10.1097/GCO.0b013e3283081ae9
883:Food and Drug Administration
531:Food and Drug Administration
428:Food and Drug Administration
7:
1832:Pharmacy benefit management
1499:America's Shadow Pharmacies
1453:Morin, Monte. (2013-04-16)
1179:Kotz, Deborah (2012-10-11)
905:Curr. Opin. Obstet. Gynecol
642:
352:IV compounding in hospitals
10:
1919:
1035:Staff (October 22, 2020).
606:deficiencies and too much
581:methylprednisolone acetate
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18:
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1574:
859:stopthethyroidmadness.com
386:This section needs to be
198:compounds made famous by
21:Compound (disambiguation)
1827:Investigational New Drug
1668:Pharmaceutical chemistry
1614:Pharmacological activity
1488:. cidreview.cidmcorp.com
288:
1809:Pharmaceutical industry
1628:Pharmaceutical sciences
1411:The Wall Street Journal
602:, a drug used to treat
369:Regulation in Australia
267:pharmaceutical industry
1079:Pharmacy Practice News
479:Outsourcing facilities
314:Patients requiring an
161:medieval Islamic world
48:compounding pharmacies
35:
1784:Pharmacist prescriber
1769:Consultant pharmacist
1357:, Wall Street Journal
1005:10.1093/ajhp/54.8.904
213:. Crude drugs, like
52:non-active ingredient
29:
1852:Pharmacies of Norway
1789:Pharmacy informatics
1683:Pharmacoepidemiology
1592:Prehistoric medicine
966:compoundingrxusa.com
114:improve this article
19:For other uses, see
1799:Veterinary pharmacy
1731:Pharmacy technician
1693:Pharmacocybernetics
1587:History of pharmacy
637:dietary supplements
150:History of pharmacy
1794:Specialty pharmacy
1757:Community pharmacy
1726:Pharmacy residency
1484:2013-05-12 at the
1309:on January 7, 2015
885:. January 10, 2002
763:. Trinity Pharmacy
685:"Compounding FAQs"
263:economies of scale
243:active ingredients
219:chemical compounds
165:Muslim pharmacists
80:drug manufacturers
36:
1890:
1889:
1847:Pharmacy in China
1774:Hospital pharmacy
1752:Clinical pharmacy
1688:Pharmacovigilance
1604:Prescription drug
1395:. New York Times.
1289:. New York Times.
968:. 4 December 2018
787:www.bayviewrx.com
600:calcium gluconate
596:Cedar Park, Texas
407:
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251:recrystallization
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32:mortar and pestle
1910:
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1842:Medication costs
1817:Drug development
1779:Nuclear pharmacy
1656:Pharmacogenomics
1644:Pharmacodynamics
1640:Pharmacokinetics
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812:. Archived from
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154:The earliest
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1376:. Retrieved
1374:. 2013-08-12
1371:
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1311:. Retrieved
1307:the original
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1259:
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1244:the original
1234:
1223:. Retrieved
1219:the original
1209:
1198:. Retrieved
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1160:the original
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1111:the original
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970:. Retrieved
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911:(4): 400–7.
908:
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887:. Retrieved
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862:. Retrieved
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814:the original
790:. Retrieved
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112:Please help
107:verification
104:
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47:
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37:
1702:Professions
1582:Compounding
629:compounding
612:Rhodococcus
577:New England
398:August 2020
362:gravimetric
235:concoctions
211:crude drugs
192:sulfa drugs
60:intravenous
44:compounding
1709:Pharmacist
1661:Toxicology
1599:Medication
1416:2012-10-09
1378:2014-02-18
1343:. Reuters.
1313:2012-12-19
1272:2014-02-18
1250:2012-02-05
1225:2014-02-18
1200:2014-02-18
1166:2010-07-18
1141:2017-02-21
1117:2014-04-09
972:2018-12-04
889:2014-02-18
864:2010-07-17
840:2010-07-17
820:2010-07-18
792:2023-01-11
672:References
649:Apothecary
561:See also:
275:penicillin
271:regulation
239:decoctions
173:drugstores
1526:from the
1268:. JDSupra
1014:1079-2082
950:(Report).
713:0350-199X
608:potassium
126:July 2010
72:outsource
34:(c. 1923)
1903:Pharmacy
1897:Category
1882:Category
1609:Pharmacy
1568:Pharmacy
1482:Archived
1372:CBS News
933:22449765
925:18660693
643:See also
440:products
231:extracts
229:to form
204:plastics
196:phenolic
181:coal tar
169:chemists
156:chemists
40:pharmacy
1862:History
1575:General
1022:9114922
746:: 3–9 .
721:9324574
631:versus
604:calcium
584:steroid
422:In the
388:updated
227:alcohol
177:Baghdad
86:History
68:topical
1642:&
1020:
1012:
931:
923:
767:8 July
719:
711:
320:gluten
202:, and
1135:(PDF)
929:S2CID
592:Texas
588:joint
289:Roles
279:brand
223:water
215:opium
1762:shop
1714:List
1530:and
1018:PMID
1010:ISSN
921:PMID
769:2014
717:PMID
709:ISSN
309:pill
237:and
167:and
64:oral
1000:doi
913:doi
249:or
225:or
116:by
66:or
1899::
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1294:^
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996:54
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485:or
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23:.
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