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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Compounded Products/Compounding

 

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: https://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: 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 formulation for UNC Hospitals Mucositis Mixture, also known as “Sleepy Butter”?

A: UNC Hospitals Mucositis Mixture has been officially added to the UNC formulary. The approved recipe by the Pharmacy and Therapeutics Committee is:

-Diphenhydramine liquid 2.5 mg/mL
-Maalox suspension (or formulary equivalent)
-Lidocaine, viscous 2%

Admix equal volumes of the three ingredients. UNC usually dispenses 300 mL total volume.

Oral Formulation.  USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions.  The directions for an oral formulation of Mucositis Mixture would be “swish and swallow” or similar.

Mucosal Liquid Formulation.  USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage.  The directions for a mucosal liquid formulation of Mucositis Mixture would be “swish and spit” or similar.

If a pharmacy compounds one batch of Mucositis Mixture to fulfil all Mucositis Mixture prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations –  the assigned BUD must be the stricter one:  no longer than 14 days under refrigerated storage.

USP <795> does allow for longer BUD for Mucositis Mixture if the pharmacy has independent stability testing information.

Recently, UNC discovered a prescription product from CutisPharma, which is a similar formula, but available in a kit (First™ Mouthwash BLM (NDC 65628-050-01)). The kit includes a 236 mL bottle of aluminum hydroxide/magnesium hydroxide/simethicone suspension with two separate bottles, one containing diphenhydramine 0.2 g powder, and the other containing lidocaine hydrochloride powder 1.6 g. The pharmacist can combine the dry powders into the suspension.

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Q: The Board office regularly receives questions on the formula for Duke's Magic Mouthwash. What is the formula?

A: Duke's Magic Mouthwash Formula:
1. Nystatin Suspension, 100,000 u/ml, 30 mL. or Nysatin Powder 3 Million Units
2. Hydrocortisone 60 mg.
3. Diphenhydramine HCL Syrup
q.s. ad. 240 ml.

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Q: What is the appropriate Beyond Use Date (BUD) for Magic Mouthwash?

A: The appropriate USP <795> BUD for Magic Mouthwash depends on whether it is compounded and dispensed as an oral formulation or as a mucosal formulation.

Oral Formulation.  USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions.  The directions for an oral formulation of Magic Mouthwash would be “swish and swallow” or similar.

Mucosal Liquid Formulation.  USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage.  The directions for a mucosal liquid formulation of Magic Mouthwash would be “swish and spit” or similar. 
If a pharmacy compounds one batch of Magic Mouthwash to fulfil all Magic Mouthwash prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations –  the assigned BUD must be the stricter one:  no longer than 14 days under refrigerated storage.

USP <795> does allow for longer BUD for Magic Mouthwash if the pharmacy has independent stability testing information.

For Commercially Available compounding kits please follow the manufacturers BUD and storage recommendations.  Their stability testing information should be included with the kit. 

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Q: Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices?

A: Consistent with the federal Food and Drug Administration's August 2006 designation of pre-filled syringes of saline/heparin (100 U/ml or 10 U/ml) flush as medical devices, the North Carolina Board of Pharmacy will likewise regulate such flushes as medical devices under the Pharmacy Practice Act.

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Q: What is the proper procedure for providing heparin, saline, sterile water for irrigation and hydration fluids to home health agencies?

A: The agency may store sterile normal saline for irrigation and sterile water for irrigation at the clinical offices.

A physician's order for one of the above for a specific patient serves as a prescription. If sterile normal saline for irrigation or sterile water for irrigation are ordered, it is not necessary for a pharmacist to dispense them. However, if the solution is left in a patient's home, it must be labeled according to pharmacy regulations.

Ideally, the labeling should be done by a pharmacist. It is not necessary for the clinical offices to obtain any type of permit issued by the Board of Pharmacy. Sterile water and sterile normal saline may be administered by the nurse with a physician's order as long as the unlabeled container is not left in the patient's home.

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Q: Is it ok to use tap water to reconstitute antibiotic granules ?

A: The Board has from time to time received inquiries about what type of water should be used to reconstitute antibiotic formulations. The Board believes that the best practice is to use purified or distilled water. Many areas in North Carolina are still served by well water, which could contain various pollutants or contaminants. Accordingly, reconstitution with purified or distilled water should minimize any possible risk to patients receiving antibiotic therapy.

 

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