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Editorial: Documentation vs Opinion on Compounding Regulatory Activities IV

This continues the series looking at some of these 483 observations and Board of Pharmacy activities and provides documentation surrounding these specific activities.

Observation: Reserve samples are not retained for one year after the expiration date.

United States Pharmacopeia (USP) Standards:

General Notices 10.40.100.1 Compounded Preparations
"�Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates [BUDs] may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products."

Comments:

Reserve samples are not a requirement for compounding pharmacy. Prescriptions are NOT samples. The USP does not state that reserve samples are required. This requirement is for GMP facilities and relates to stability and bioequivalency samples that must be retained for one year. The USP General Notices plainly state that compounded preparations must contain a (BUD) and this BUD can be determined differently than the procedures required by the FDA for establishing expiration dates. Expiration dates are applied to manufactured products with an expected shelf life of about 2 to 3 years. BUDs are for up to 6 months but generally much shorter than that.

In addition, the maximum BUD for compounded preparations is generally up to only 6 months. It is useless to store a preparation for one year after the BUD of the drug (i.e., up to 18 months total). Also, this is not practical. If a pharmacy compounds about 100 preparations per day and is open 250 days per year, this is 25,000 "samples" that must be retained for one year (again, not practical). Manufacturers do only a very few different products or bioequivalency studies per day so their storage is more reasonable.

Also, patient-specific compounding does not include compounding excess preparation as retention samples because that excess would be non-patient specific preparation.

Summary:

The observation that reserve samples are not retained for one year after the expiration date does NOT apply to compounding pharmacies licensed by the state boards of pharmacy.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy

Drug Shortages Still Here
The total number of active drug shortages has remained constant nearly a year after Congress passed legislation to try to minimize the shortages. At the end of April, the University of Utah Drug Information Service counted 300 "active" drug shortages, just about the same as it did at the end of December 2012 (299 shortages) and September 2012 (282 shortages). On a positive note, the number of "new" shortages is well off its pace from years past, with 54 so far this year.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/39090

Injectable Methotrexate Recalled Due to Particulates
Sandoz has initiated a recall of two lots of injectable methotrexate sodium (25 mg/mL and 40 mL) in the U.S. after discovering particulate matter in vials during routine quality checks of samples at the manufacturer. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). Sandoz stated that the particulates are not associated with microbial contamination. However, particulate matter in parenteral drugs is a "potential health hazard."
http://www.medscape.com/viewarticle/804542

Texas Bill Designed to Increase Pharmacy Rate Transparency
Independent pharmacists that are struggling to keep their businesses open could soon see more transparency in negotiating rates with Medicaid managed-care organizations. The reimbursement rates in Texas were the same throughout the state until March 2012 when Texas expanded managed care. At that time, pharmacists were required to sign contracts with multiple managed-care organizations and agree to rates set forth for Medicaid prescriptions even though they often wouldn't know the rates they'd be paid for specific drugs prior to signing the contract. The bill would require Medicaid managed-care plans to report to the state quarterly how much they're paying each provider in their network for the same drugs; it would reveal if they're paying different amounts to different providers.
http://www.texastribune.org/2013/05/17/house-advances-bill-protect-pharmacies-low-medicai/

Some Indian Drug Prices to Fall Up to 80%
India's new Drug Price Control Order (DPCO) has now been introduced and is expected to lead to reductions in the prices of 348 essential drugs by up to 80%. Because of this, the ceiling prices of products will be set at the simple average of all brands with a market share of at least 1%, replacing the current cost-plus basis, and this should see many prices of drugs, including cancer treatments and anti-infectives, decline by as much as 80%.
http://www.pharmatimes.com/Article/13-05-17/Indian_essential_drug_prices_to_fall_up_to_80.aspx

Janssen CEO Faces Legal Action in Korea
Korea's government has decided to file a criminal complaint against the head of Janssen Korea for manufacturing and selling dangerous medicine. Also, the pharmaceutical unit of Johnson & Johnson is to suspend production of five types of medicine for up to five months. These punitive measures are heavier than usual because of the firm's multiple violations. Under the Pharmaceutical Affairs Law, the CEO may face three years behind bars.
http://www.koreatimes.co.kr/www/news/nation/2013/05/116_135850.html

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�that this is Memorial Day weekend? Take time to honor those who have gone on before us!

With Memorial Day and graduation exercises, there are many opportunities to interact and encourage your patients in a positive way.

Don't stick your elbow
Out so far,
It might go home
In another car!
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Avella of Greyhawk, Inc., Scottsdale, Arizona; Linda Cappellini, RPh; Linda.Cappellini@avella.com. Re-accreditation for Sterile & Nonsterile Compounding

Leesburg Pharmacy Inc., DBA The Compounding Center, Leesburg, Virginia; Jay Gill, PharmD; jay@compoundingcenter.com. Re-accreditation for Sterile and Nonsterile Compounding