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Editorial: Documentation vs Opinion on Compounding Regulatory Activities VI

This continues the series looking at some of the 483 observations and Board of Pharmacy activities. This week we will list some of the observations that show lack of compliance with United States Pharmacopeia (USP) Chapters <795> and <797> that require correction by the inspected pharmacies. This can be used as a tool to have all those involved in sterile compounding to review their SOPs and actual practice that involves each of these observations. We will cover more of these over the next few weeks.

Observations: (Regarding Environmental Monitoring)

1. There is no SOP delineating the frequency of environmental monitoring in the cleanroom facility.
2. There are no established "alert limits."
3. No corrective action taken when environmental monitoring demonstrates alert limits exceeded.
4. There is no viable/non-viable particulate air monitoring.
5. Hoods and cleanrooms are only infrequently monitored and then only under static conditions.
6. Glove fingertip monitoring not sufficiently frequent.
7. Hood monitoring not done every day that parenterals are compounded.
8. There is little or no documentation of surface or air sampling.
9. Entries in logbook are not documented.
10. Surface-sample plate only incubated at room temperature.
11. ISO 5 work area contains duct tape, power outlet strip, radio, electronic scanner; all not easily cleanable.
12. Failure to use positive and negative controls in environmental monitoring.
13. No environmental monitoring performed.
14. No environmental monitoring SOP in place.

Reviewing these weekly lists with personnel responsible for compounding sterile preparations (CSPs) can be a valuable experience!


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

Opposition to Compounding Bill
Compounding pharmacies are mounting opposition to a Senate bill they say would give the FDA unprecedented authority over their professional practice. The bill that was approved unanimously by the Senate Health, Education, Labor and Pension Committee late last month would give the FDA increased regulatory power over compounding manufacturers. The group, My Meds Matter, is circulating a petition to protest the bill.
http://thehill.com/blogs/regwatch/healthcare/304187-pharmacies-say-harkin-bill-would-give-fda-unprecedented-powers

Senators Request Rapid Vote on Drug Compounding Bill
Leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee have requested a quick vote on legislation that would enable federal regulators to oversee non-traditional drug compounders. HELP Chairman Tom Harkin (D-Iowa) and ranking member Lamar Alexander (R-Tenn.) warned that unless their bill comes to the floor in July, patients could experience another outbreak of disease tied to compounded drugs. The senators wrote on Friday:

We have worked with pharmacists, physicians, patients, consumer groups, state boards and the [Food and Drug Administration] for over 6 months to craft this bipartisan legislation. It provides the necessary clarity and accountability to ensure the proper oversight of all compounded drugs.

Lawmakers have been working to strengthen regulation of non-traditional compounders since the New England Compounding Center caused a deadly outbreak of meningitis last fall.
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/304509-senators-urge-swift-vote-on-drug-compounding-bill

Novartis India Probes Sales Practices
Novartis India executives allegedly manipulated sales data and circumvented ethical trade practices to accelerate sales of diabetes therapy Galvus. Novartis has reportedly launched investigations and initiated remedial action.

Some executives allegedly were inflating and presenting fabricated sales data for industry-leading Galvus (vildagliptin). In swift retaliation, Novartis is believed to have fired at least 18 executives and has launched a nationwide probe focused on remedial steps.

Executives are now being investigated for allegedly padding invoices and then buying stocks of the diabetes drug from wholesalers with cash rewards that had been doled out as incentives. The representatives reported false sales in order to match steep sales targets set for them. In addition, the sales reps fabricated invoices with fictitious names, in effect blocking the billed goods and keeping them in their possession. The payments—from the wholesaler to the company—were settled from sales force incentive money that is balanced at the end of each quarter as a standard practice.
http://www.elsevierbi.com/publications/pharmasia-news/2013/6/10/exclusive-novartis-india-probes-sales-practices-for-galvus-heads-roll?elsca2=rss&elsca1=pan

Mislabeling Caused Death in France?
The French police are regarding the death of a 92-year-old man as "suspicious" after he was given medicine that may have been wrongly labeled as a diuretic drug. The man's death occurred two days after France's pharmaceutical watchdog ANSM asked pharmacies to take off the shelves 190,000 boxes of the diuretic furosemide supplied by Israeli drugmaker Teva, saying that they may contain the sedative zopiclone. The ANSM also asked patients who had been sold some of the identified batch of boxes to return them to their pharmacies.
http://www.reuters.com/article/2013/06/09/france-drug-idUSL5N0EL0GT20130609

Pharmacy Chain Halts Sale of Ranbaxy Drugs
Apollo Pharmacy, India's largest branded drug retail network with over 1,500 outlets, has temporarily suspended sale of medicines manufactured by Ranbaxy Laboratories. It has also stopped further procurement from the company for now.

Apollo Pharmacy is a division of healthcare major Apollo Hospitals Enterprise Ltd. The chain is present across the country, both as stand-alone standard stores and those attached to AHEL hospitals and clinics. Apollo Pharmacy's move has come a little over a week after Mumbai's Jaslok Hospital issued an advisory to its doctors to avoid prescribing Ranbaxy drugs.
http://www.business-standard.com/article/companies/apollo-pharmacy-halts-sale-of-ranbaxy-drugs-113060700036_1.html

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�that Father's Day is a celebration honoring fathers and the influence of fathers in society? Many countries celebrate it on the third Sunday of June, but it is also celebrated widely on other days. Father's Day was created to complement Mother's Day.

It was founded in Spokane, Washington YMCA in 1910 by Sonora Smart Dodd. Her father, a Civil War veteran, William Jackson Smart, was a single parent who raised his six children there. A sermon about Mother's Day in 1909 by her pastor initiated the process so that fathers would eventually have a similar holiday honoring them. In 1957, Maine Senator Margaret Chase Smith wrote a proposal accusing Congress of ignoring fathers for 40 years while honoring mothers. In 1966, President Lyndon B. Johnson issued the first presidential proclamation honoring fathers, designating the third Sunday in June as Father's Day. Six years later, the day was made a permanent national holiday when signed into law in 1972.

IACP's 19th Annual Compounders on Capitol Hill, June 1-4, 2013 at the Crystal Gateway Marriott in Arlington, Virginia drew more than 400 attendees, including 100 first-time attendees! Plan on attending next year!

Mug and brush,
Old Adam had 'em!
Is your husband
Like Adam, Madam?
      Burma Shave

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

Koshland Pharm: Custom Compounding Pharmacy, San Francisco, California; Peter Koshland, PharmD, peter@koshlandpharm.com. Re-accreditation for Nonsterile Compounding