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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Compounded Products/Compounding

 

FRIDAY, NOVEMBER 17, 2017

Guidance Document - Compounding Record and Master Formulation Record for Sterile Compounds

 

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THURSDAY, JANUARY 26, 2017

FDA ISSUES FINAL GUIDANCE DOCUMENTS ON THE USE OF BULK DRUG PRODUCT FOR COMPOUNDING BY PHARMACIES AND OUTSOURCING FACILITIES.  The Food and Drug Administration has issued final guidance on the use of bulk drug product for compounding by pharmacies (under Section 503A of the Food, Drug, and Cosmetic Act) and outsourcing facilities (under Section 503B of the Food, Drug, and Cosmetic Act).  All compounders should give these documents their immediate attention:

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Q: Where can I find information concerning human drug compounding?

A: The FDA's final guidance document and other information on Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities may be found here: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm

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Q: What are USP standards governing hazardous drug handling?

A: On February 1, 2016, USP published the final version of chapter <800>, which sets forth standards for handling hazardous drugs in health care settings – including, obviously, pharmacies.  Chapter <800> helps ensure patient safety, worker safety, and environmental protection.  These standards apply to healthcare personnel who handle hazardous drugs, and to all entities that store, prepare, transport, or administer hazardous drugs. The standards become effective on  July 1, 2018.  After that, Board of Pharmacy staff will be inspecting and enforcing these new standards, which are incorporated by reference into USP chapters <795> and <797> governing compounding.  You can access the USP <800> standards through this link: http://www.ncbop.org/faqs/USPChapt800HazardousDrugsFeb2016.pdf.

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MONDAY, DECEMBER 22, 2014 - AMENDED PHARMACY COMPOUNDING RULES GO INTO EFFECT ON JANUARY 1, 2015.  The Board has completed its rulemaking to amend the rules governing pharmacy compounding.  The amended rules were approved by the Rules Review Commission on December 17, 2014 and will go into effect on January 1, 2015.  The Board appreciates the thoughtful commentary on the proposed rules from practitioners and others.  The rules as amended may be found here: http://www.ncbop.org/LawsRules/FinalCompoundingRulesJan2015.pdf.

 

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Q.  Does the federal Drug Quality and Security Act prohibit a pharmacy from compounding veterinary drugs for “office use”?

A.  No. The federal Drug Quality and Security Act speaks to compounding of human drug products.  The FDA’s most current statement of regulatory policy governing veterinary compounding may be found here: http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm446862.pdf.

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Q: What resources are recommended for guidance on compounding/sterile compounding services?

A: The American Society of Health-System Pharmacists (ASHP) provides several resources to help pharmacists and other providers address the new responsibilities and demands resulting from the fungal meningitis outbreak caused by contaminated methylprednisolone acetate injection compounded by NECC. The ASHP Sterile Compounding Resource Center (http://www.ashp.org/sterilecompounding) includes tools to help ensure that sterile products are safe for patients such as the “Outsourcing Sterile Products Preparation: Contractor Assessment Tool” and publications such as a checklist of Eight Critical Steps Related to Sterile Compounding Services.

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Q: Is it permissible to compound domperidone?

A: Domperidone compounding is permissible only as part of an investigational new drug application (IND). Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. The FDA has long provided clear guidance on this point, which may be found here: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm368736.htm

As FDA’s information further states, "FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women." Domperidone may be useful for "some patients with severe gastrointestinal disorders . . . that are refractory to standard therapy." A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). An FDA-authorized IND would "allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S."

Pharmacists are expected to conform their conduct to these legal requirements.

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Q: Has the FDA taken action against pharmacies that compound "bio-identical hormone replacement" products?

A: Yes. See http://www.fda.gov/newsevents/newsroom/pressannouncements/2008/ucm116832.htm.

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Q: Must a prescription label state the drug's generic name?

A: Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone".

Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke’s Mouthwash" or "Compounded Cafergot".

This rule is intended to meet a health need and is not meant as a punitive measure. Board staff does expect pharmacies to be in compliance within a reasonable time.

Some patients have expressed confusion over the rule. A consumer-friendly explanatory FAQ is available here.

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Q: Should I compound Itraconazole?

A: Pharmacists should note the following important information regarding compounding of itraconazole products from the bulk chemical:

Itraconazole bulk powder (brand name - Sporonox) is NOT bioavailable in mammalian species. All of the commercially available Itraconazole products (capsules, oral solution and injectable) are complexed onto a cyclodextran molecule to increase solubility and systemic bioavailability. Unless compounding pharmacists are also utilizing this cyclodextran technology, the Itraconazole products from bulk chemical are not being absorbed and are therapeutically worthless. Dr. Mark Papich, our clinical pharmacologist, has studied the bioavailability of Itraconazole (both FDA-approved and compounded from bulk) in animal patients, and the bulk chemical is simply not bioavailable. We have had MULTIPLE therapeutic failures (and some resulting deaths in dogs suffering from blastomycosis) in the veterinary community from Itraconazole capsules and suspension compounded from the bulk chemical. We had another therapeutic failure today that resulted from the compounding pharmacist offering to compound Itraconazole suspension because the commercially available products are "too expensive". As most of the systemic fungal infections that animals suffer from are life-threatening, we must do everything we can to educate compounding pharmacists to stop compounding with Itraconazole bulk chemical. Thank you for any intervention that you might be able to provide.

Gigi Davidson, BSPh, RPh, DICVP
Director of Clinical Pharmacy Services
North Carolina State University College of Veterinary Medicine 4700 Hillsborough Street Raleigh, NC 27606
email: gigi_davidson@ncsu.edu

phone: 919-513-6575
fax: 919-513-6571

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Q: What is the FDA's position on the compounding of hydroxyprogesterone caproate injection?

A: Many pharmacists are aware that the FDA approved Makena, a hydroxyprogesterone caproate injection, to be marketed by KV Pharmaceuticals. FDA has issued the following statement with respect to compounding of hydroxyprogesterone caproate injection: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm 
JULY 2014 UPDATE:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm402614.htm

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Compounding for Animal Patients

MONDAY, JUNE 15, 2015

FDA Issues Draft Guidance on Use of Bulk Substances In Compounding for Animal Patients.  On May 19, 2015 the Center for Veterinary Medicine of the Food and Drug Administration (FDA CVM) issued a draft Guidance for Industry (GFI) #230 Compounding Animal Drugs From Bulk Drug Substances and rescinded Compliance Policy Guide (CPG) 608.400 Compounding of Drugs For Use In Animals. CPG 608.400 has been in effect since its inception in 1996 and was revised in 2003. FDA CVM issued GFI #230 in response to sweeping changes in compounding regulation caused by the Drug Quality and Security Act of 2013 in order to bring regulatory enforcement for animal compounding more in line with that for humans. GFI #230 now represents FDA CVM’s current thinking on use of bulk drug substances when compounding for non-human patients.

Board staff thanks Gigi Davidson, BSPh, DICVP, Director of Clinical Pharmacy Services at the NC State College of Veterinary Medicine, for preparing this summary and FAQ guidance.  Gigi also serves as Chair of the USP Compounding Expert Committee. Draft Guidance /FAQs on Use of Bulk Substances In Compounding for Animal Patients.

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