Showing posts with label beyond-use date. Show all posts
Showing posts with label beyond-use date. Show all posts

Thursday, July 11, 2013

Specialty Pharmacy News Samford Pharmacy Grant Will Put Science Behind Beyond-Use Dates: Samford University’s McWhorter School of Pharmacy has received a $10,000 International Academy of Compounding Pharmacists Foundation grant to support research in compounded pain formulations.

read article here
Samford University’s McWhorter School of Pharmacy has received a $10,000 International Academy of Compounding Pharmacists Foundation grant to support research in compounded pain formulations.


Pharmacy professors Dr. John Arnold and Dr. Gregory S. Gorman will use the funds to evaluate aspects of a compounded product’s assigned beyond-use date (BUD), sometimes a problematic call for a dispensing pharmacist.

When compounding pharmacists prepare specialty formulations that are not commercially available, they assign a BUD to represent how long the mixture is believed to be potent.  Because a compound may contain multiple active ingredients from various drug classes, assigning an accurate BUD can be challenging.

“Generally, these dates are assigned by using best practices and U.S. Pharmacopeia guidelines,” said Gorman. “The basis of the project is to put some science behind these dates.”

The researchers will measure the potency of several of the most commonly compounded topical pain creams over a specified time period. In addition to generating BUD data, the experiments will determine efficacy based on how much of the active ingredients penetrates skin.

“We want to make sure that we, as pharmacists, give appropriate expiration dates so that patients aren’t using medications that are no longer potent,” said Arnold.

The grant is designated for a 12-month time span, which began July 1.  The research will take place in faculty laboratories in Samford pharmacy school’s Ingalls Hall.

The two professors bring complementary but different strengths to the project: Gorman as an analytical chemist with experience in drug discovery and development, and Arnold as a pharmacist with expertise in compounding in practice. - See more at: http://www.specialtypharmacytimes.com/news/Samford-Pharmacy-Grant-Will-Put-Science-Behind-Beyond-Use-Dates#sthash.FT5IyEBZ.dpuf
Samford University’s McWhorter School of Pharmacy has received a $10,000 International Academy of Compounding Pharmacists Foundation grant to support research in compounded pain formulations.


Pharmacy professors Dr. John Arnold and Dr. Gregory S. Gorman will use the funds to evaluate aspects of a compounded product’s assigned beyond-use date (BUD), sometimes a problematic call for a dispensing pharmacist.

When compounding pharmacists prepare specialty formulations that are not commercially available, they assign a BUD to represent how long the mixture is believed to be potent.  Because a compound may contain multiple active ingredients from various drug classes, assigning an accurate BUD can be challenging.

“Generally, these dates are assigned by using best practices and U.S. Pharmacopeia guidelines,” said Gorman. “The basis of the project is to put some science behind these dates.”

The researchers will measure the potency of several of the most commonly compounded topical pain creams over a specified time period. In addition to generating BUD data, the experiments will determine efficacy based on how much of the active ingredients penetrates skin.

“We want to make sure that we, as pharmacists, give appropriate expiration dates so that patients aren’t using medications that are no longer potent,” said Arnold.

The grant is designated for a 12-month time span, which began July 1.  The research will take place in faculty laboratories in Samford pharmacy school’s Ingalls Hall.

The two professors bring complementary but different strengths to the project: Gorman as an analytical chemist with experience in drug discovery and development, and Arnold as a pharmacist with expertise in compounding in practice. - See more at: http://www.specialtypharmacytimes.com/news/Samford-Pharmacy-Grant-Will-Put-Science-Behind-Beyond-Use-Dates#sthash.FT5IyEBZ.dpuf
Pharmacy professors Dr. John Arnold and Dr. Gregory S. Gorman will use the funds to evaluate aspects of a compounded product’s assigned beyond-use date (BUD), sometimes a problematic call for a dispensing pharmacist.

When compounding pharmacists prepare specialty formulations that are not commercially available, they assign a BUD to represent how long the mixture is believed to be potent.  Because a compound may contain multiple active ingredients from various drug classes, assigning an accurate BUD can be challenging.

“Generally, these dates are assigned by using best practices and U.S. Pharmacopeia guidelines,” said Gorman. “The basis of the project is to put some science behind these dates.” - See more at: http://www.specialtypharmacytimes.com/news/Samford-Pharmacy-Grant-Will-Put-Science-Behind-Beyond-Use-Dates#sthash.FT5IyEBZ.dpuf
Pharmacy professors Dr. John Arnold and Dr. Gregory S. Gorman will use the funds to evaluate aspects of a compounded product’s assigned beyond-use date (BUD), sometimes a problematic call for a dispensing pharmacist.

When compounding pharmacists prepare specialty formulations that are not commercially available, they assign a BUD to represent how long the mixture is believed to be potent.  Because a compound may contain multiple active ingredients from various drug classes, assigning an accurate BUD can be challenging.

“Generally, these dates are assigned by using best practices and U.S. Pharmacopeia guidelines,” said Gorman. “The basis of the project is to put some science behind these dates.” - See more at: http://www.specialtypharmacytimes.com/news/Samford-Pharmacy-Grant-Will-Put-Science-Behind-Beyond-Use-Dates#sthash.FT5IyEBZ.dpuf
Pharmacy professors Dr. John Arnold and Dr. Gregory S. Gorman will use the funds to evaluate aspects of a compounded product’s assigned beyond-use date (BUD), sometimes a problematic call for a dispensing pharmacist.

When compounding pharmacists prepare specialty formulations that are not commercially available, they assign a BUD to represent how long the mixture is believed to be potent.  Because a compound may contain multiple active ingredients from various drug classes, assigning an accurate BUD can be challenging.

“Generally, these dates are assigned by using best practices and U.S. Pharmacopeia guidelines,” said Gorman. “The basis of the project is to put some science behind these dates.” - See more at: http://www.specialtypharmacytimes.com/news/Samford-Pharmacy-Grant-Will-Put-Science-Behind-Beyond-Use-Dates#sthash.FT5IyEBZ.dpuf

Tuesday, February 12, 2013

Allen's Guidelines for Compounding Practices Contain Excellent Discussion on Stability, Expiration and Beyond Use-Date for Compounded Medications



Guidelines for Compounding Practices - chapter from The Art, Science, and Technology of Pharmaceutical Compounding, 4th edition (Washington, DC: American Pharmacists Association; 2012), author, Loyd V. Allen Jr. contains an excellent discussion of stability, expiration and beyond use-date.  This article is reprint on the American Pharmacist's Association Website found here

Tuesday, June 12, 2012

Tennessee Law Regarding Beyond-Use or Expiration Date on Compounded Drugs

Tennessee Board of Pharmacy recently reminded all pharmacy personnel of the state law requiring them to check compounding medications and ingredients that are past the beyond-use r expiration dates.

In its June 2012 newsletter found here, the Board stated:

Expired Medications Continue to Be Found on Pharmacy Shelves

As a reminder to all pharmacy personnel, it is advised to segregate all expired medications from stock, mark for destruction, and immediately destroy or return these items to a reverse distributor for destruction. Also, do not forget to check compounding medications and ingredients that are past the beyond-use or expiration date. Refer to Tennessee Board of Pharmacy Rule 1140-03-.11, which states:
The owner or pharmacist in charge of a pharmacy practice site shall immediately return or destroy all outdated, defective, or deteriorated prescription drugs and devices and related materials; except that the destruction of controlled substances listed in any schedule shall be performed by a board approved agent or vendor.

Historically, the Board has approved issuance of a letter of warning and/or civil penalties, depending on the facts associated with the violation.