Donfucius Says: September 2nd, 2010. Random Bits Of Wisdom.

If you know the answer to this question, give yourself 100 points for being smart.

In the 1970’s and 1980’s, who was the only person ever to play for the Milwaukee Brewers (baseball), the Milwaukee Bucks (basketball), and the Milwaukee Admirals (hockey).

The answer: Frank Charles, the very talented organist. He “played” for all three teams.

Photo Above: Frank Charles (left) and Donald Dobert, Milwaukee County Stadium, 1973.

Photo Below: Frank Charles and Doug Czarnecki (ATL Project Engineer, then 9 years old), Milwaukee County Stadium, 1973.

Today I take time to thank Frank Charles for all of the wonderful memories he provided for baseball, basketball, and hockey fans. Mr. Charles played the organ for many, many years and was very kind to me when I was a young man.

In my everyday business world I use some of Frank’s great examples in my dealings with people, for Frank was always friendly and paid attention to things I was interested in. The small things he always did (for everyone) has been something that I fondly remember, even after nearly forty years.

Frank, thank you for all of the kindness, entertainment, and memories.

Photo Below: Frank Charles at Miller Park for the 2002 (Twenty Year) reunion of the 1982 Milwaukee Brewers team.

Photo Below: Frank Charles, forever a Brewers fan, in his Florida home (along with greats Paul Molitor and Robin Yount). He calls this room his “Wisconsin Den”.

Lawsuits allege imitation Coach handbags, wallets and accessories sold at 13 stores.

This story courtesy of Gus G. Sentementes, “The Baltimore Sun”.

Ocean City’s boardwalk is known for small shops hawking salt water taffy and souvenirs to vacation-goers. But a major luxury brand has accused more than a dozen shops of doing brisk trade in an illegal market: counterfeit handbags and accessories. Over two days in June, an investigator with Coach Inc. entered 13 stores overlooking the beach and bought counterfeit bags, wallets and other items for prices ranging from $20 to $75, according to lawsuits filed by Coach in federal court in Baltimore this week. Authentic Coach handbags in a similar style are sold for more than $300, according to the company’s website.

In some cases, the investigator said the shops had dozens of imitation Coach products for sale. And, in at least one instance, a shop employee admitted to the undercover investigator that the items were fake, according to the lawsuits.

“To those who traffic in counterfeit goods the message is simple: Coach is looking for you and, once found, will seek the maximum penalties available, including substantial monetary payments,” said Nancy Axilrod, associate general counsel for Coach, in an email to The Baltimore Sun.

Coach and other big-name brands – from Chanel to Louis Vuitton – routinely work with federal and local law enforcement to fight a multibillion-dollar trade in counterfeit goods, many of which originate from China through organized crime networks.

But the fight against counterfeit goods has been complicated in recent years by sellers of illicit products moving online and beyond the traditional hubs of black market knockoffs in New York and Los Angeles to other foot traffic-heavy locales like Ocean City, experts said. In at least one case this year, Coach sued a municipality – Chicago – for not doing enough to crack down on street vendors selling counterfeit company products at a city-run public market.

According to the International AntiCounterfeiting Coalition, a nonprofit based in Washington, the worldwide trade in counterfeit goods amounts to about $600 billion a year. In the U.S. alone last year, Customs and Border Patrol and Immigration and Customs Enforcement seized $260 million worth of counterfeit goods. The top categories of seized counterfeit goods included footwear, consumer electronics, apparel, computer hardware, pharmaceuticals, toys and electronic games, according to the federal agencies.

Companies “are all very serious about it,” said Robert C. Barchiesi, president of the International AntiCounterfeiting Coalition in Washington, which represents more than 200 companies. “Most consumers think it’s a bargain when they buy these goods, but they need to think again because the societal costs are enormous.” Counterfeit goods lead to lost tax revenue and jobs as well as the diminishment of brands in the eyes of consumers who interact with imitation goods, Barchiesi said. “If people are walking around with inferior bags, that doesn’t go far toward protecting the reputation of these quality brands,” Barchiesi said.

In its investigation in Ocean City, Coach alleges that the shops sold handbags, wallets, key chains and wristlets. The shops named in the lawsuits are: Maytalk; Beach Break; Hot Topik; Ocean Reef; Summer Breeze; Surf Beachwear; the Fashion Shop; Ocean Waves; Sunset Beachwear; New York New York; Jewel of the Ocean; Oceanfashion Boutique; and Sunglass City. According to online federal court records, the owners of the shops had not been served with the lawsuits as of Tuesday.

Employees at several locations declined to comment, and management at those stores did not return phone calls. A manager at Oceanfashion Boutique, who refused to give her name, denied that the shop sold Coach counterfeit products. Coach is seeking $2 million in damages for each counterfeit violation at each store or, alternatively, a court order for the store owners to pay Coach all of the profits earned from the sale of the items.

Coach’s lawsuits against the Ocean City shops come as the company has launched its own nationwide campaign, now in its second year, to crack down on the sale of imitation products. Last May, the company kicked off “Operation Turnlock,” a zero-tolerance civil litigation program targeting producers, wholesalers and retailers of Coach fakes. The New York-based company is actively fighting the illegal trade of knockoffs in lawsuits against stores across the country, according to federal court records. So far, Coach has filed about 250 lawsuits and has secured court judgments and settlements for hundreds of thousands of dollars in damages, according to Coach’s Axilrod.

High-profile busts of smuggling rings are routine. Earlier this month, federal authorities shut down a ring in San Francisco that was selling imitation Coach, Kate Spade, Armani and other luxury brands, worth potentially $100 million.

In March, nine people were indicted in federal court and accused of transporting, in 33 shipping containers, hundreds of thousands of fake Nike shoes, Coach bags, Cartier watches and Gucci shoes through the port of Baltimore.

by Stephanie Clifford – Courtesy of “The New York Times”.

Photo Above: On Broadway in New York, shoppers can pick up items of questionable authenticity, and not just of the top luxury brands.

After years of knocking off luxury products like $2,800 Louis Vuitton handbags, criminals are discovering there is money to be made in faking the more ordinary – like $295 Kooba bags and $140 Ugg boots. In California, the authorities recently seized a shipment of counterfeit Angel Soft toilet paper.

The shift in the counterfeiting industry, which costs American businesses an estimated $200 billion a year, plays to recession-weary customers looking for downmarket deals, the authorities say. And it has been fueled in part by factories sitting idle in China. Almost 80 percent of the seized counterfeit goods in the United States last year were produced in China, where the downturn in legitimate exports during the recession left many factories looking for goods – in some cases, any goods – to produce. “If there is demand, there will be supply,” said John Spink, associate director of the Anti-Counterfeiting and Product Protection Program at Michigan State University. In China, he said, “It’s all of a sudden them saying, ‘We have low capacity. What can we make?’ ”

The answer is increasingly knockoffs of lesser-known brands, which are easy to sell on the Internet, can be priced higher than obvious fakes, and avoid the aggressive programs by the big luxury brands to protect their labels, retail companies and customs enforcement officials say. The results: Faux Samantha Thavasa bags for $113 and Ed Hardy hoodie sweatshirts for $82.50. And, bizarrely, imitations that are more expensive than the real ones: In 2007, Anya Hindmarch sold canvas totes that said “I’m Not a Plastic Bag” for $15. Now fakes are available on the Web for $99. “If it’s making money over here in the U.S., it’s going to be reverse-engineered or made overseas,” said Jonathan Erece, a trade enforcement coordinator for United States Customs and Border Protection in Long Beach, Calif. “It’s like a cat-and-mouse game.”

The traders in mid-price fakes are employing another new trick: by pricing the counterfeits close to retail prices – which they can do when the original product is not too expensive – they entice unsuspecting buyers. Any savvy shopper, for example, knows a Louis Vuitton bag selling for $100 cannot be the real thing. But when NeimanMarcus.com, an authorized retailer for Kooba bags, sells them for $295, and a small Web site sells them for $190, a deal-hunting consumer could think she has scored a bargain. (She hasn’t. The $190 bag is a fake.) “If the price points are somewhat close, some consumers get duped into believing they’re getting a real product,” said Robert Barchiesi, president of the International AntiCounterfeiting Coalition, a trade group. “They might be looking for a bargain, but a bargain to buy real goods.”

Photo Below: At the Port of Long Beach, an officer at the Customs and Border Protection office inspects a toy for entry into the country.

The counterfeiters are also lifting photos and text from legitimate Web sites, further fooling some shoppers. “The consumer is blind as to the source of the product,” said Leah Evert-Burks, director of brand protection for Ugg Australia’s parent company, the Deckers Outdoor Corporation. “Counterfeit Web sites go up pretty easily, and counterfeiters will copy our stock photos, the text of our Web site, so it will look and feel like” the company site, she said.

While all of it is illegal, the authorities do not publish statistics on what brands’ products are being counterfeited. But designers and trade experts said the downmarket trend in counterfeiting became more noticeable over the last year, as counterfeiters got more inventive. The field is big: the total value of counterfeit goods seized by United States customs officials increased by more than 25 percent each year from 2005 to 2008, using the government’s fiscal calendar. In fiscal 2009, as imports over all dropped by 25 percent, the value of counterfeit products seized dropped by only 4 percent to $260.7 million. The official statistics capture only a piece of the problem, companies and experts say, because so many counterfeiters market directly to customers on the Internet and many of those sales go undetected by the authorities. “Online is much harder” to patrol and enforce, said Todd Kahn, general counsel for Coach, the handbag and accessories company. That is particularly true for smaller brands, as Anna Corinna Sellinger, co-founder and creative director of the New York clothing and accessories company Foley & Corinna, learned.

A couple of years ago, she began checking out which Foley & Corinna items were selling on eBay. Her city tote, which now retails for $485, was a popular item, but on some listings “there was something off – it’s a color I never did, or a leather I never did,” she said. As other sites proliferated, and Ms. Corinna Sellinger noticed more and more Internet fakes, she stopped looking altogether. “It’s just too frustrating,” she said. “You can try to do something, but it’s so big and so fast.”

While Ms. Corinna Sellinger basically had herself and a computer to patrol for fakes, big companies use legal teams who train customs officials on the nuances of their product, monitor the Web, ask Internet service providers to take down copycat sites and file lawsuits against sellers. (The brands only go after sellers; the law in the United States does not prohibit consumers from buying counterfeit products.) Ugg Australia, the popular boot brand, developed a full enforcement program after it realized how prevalent copies of its boots were. In 2009, 60,000 pairs of boots were confiscated by customs agents globally, Ms. Evert-Burks said. In the same year, the company took down 2,500 Web sites selling fake products, along with 20,000 eBay listings and 150,000 listings on other trading sites like Craigslist and iOffer. That’s despite the relatively low price of real Ugg boots, which cost around $140 for a basic model. Under similar programs, Versace won $20 million in a recent lawsuit against counterfeiters, while Gucci, Louis Vuitton and other luxury brands have been pursuing similar cases. Coach last year announced “Operation Turnlock,” in which it would file civil lawsuits against counterfeiters, and it has sued 230 times, Mr. Kahn said. At Liz Claiborne Inc., which owns brands like Juicy Couture and Kate Spade, the company has gone after 52 Web sites selling counterfeits, and removed 27,000 auction listings so far this year.

Photo Below: Counterfeit boots are destroyed in Australia after a court sided with Deckers Outdoor, owners of the Ugg boot line.

The lesson for many counterfeiters has been that they have a better chance of getting away with it if they copy smaller brands like Foley & Corinna – even though Foley & Corinna, while popular with celebrities and fashion types, is not widely recognized as a status brand and its bags can be had for as little as $126 on the brand’s own Web site. “Once it’s out there a lot, people won’t even want the real one because then they’re like, ‘People are going to think it’s fake,’ ” Ms. Corinna Sellinger said. “It takes the product away from the designer.”

The US Food and Drug Administration announced plans to revise CGMP regulations.

By: Angie Drakulich. This story is courtesy of ePT–the Electronic Newsletter of Pharmaceutical Technology.

The US Food and Drug Administration announced plans to revise the current good manufacturing practice (GMP) regulations at a conference held jointly by the agency and Xavier University in Cincinati, Ohio, June 13-16. Brian Hasselbalch, representing the Office of Compliance’s Division for Manufacturing and Drug Product Quality within FDA’s Center for Drug Evaluation and Research, was speaking as part of the first joint annual Global Outsourcing Conference at the school.

According to Haselbalch’s presentation, which is available on the Xavier website, a draft of new CGMP regulations focusing on component controls is expected before the year’s end. Potential revisions include requiring pharmaceutical manufacturers to physically audit their suppliers (i.e., no more paper audits), test containers in each shipment received, implement tamper-evident packaging and security features, notify FDA of contaminated shipments and lots, and to use only those components recognized as safe for their intended use or listed in an already approved application.

In addition to increased enforcement and information-sharing, FDA also plans to play a stronger “guiding role” in corporate responsibility. Hasselbalch offered some recent guidance documents as examples of FDA’s role in encouraging corporate responsibility: process validation, pharmaceutical quality systems, and testing of glycerin for diethylene glycol. It seems the agency will go even further by issuing a second phase of revised CGMP regulations that focus specifically on corporate responsibility. These revisions might include requirements that management assures compliance, performs self-inspections, evaluates and investigates problems, implements change control, and documents training and effectiveness, according to the presentation.

What’s behind the proposed changes? Hasselbalch’s presentation noted growing gaps in quality control caused by factors such as globalization, new technologies and processes, distribution challenges, and increased outsourcing of production. Between 2001 and 2007, he pointed out, the number of products manufactured outside the United States and the number of manufacturing sites abroad doubled. Some of the new products being imported into the US come from countries with “less developed regulatory systems,” according to the presentation. Along with these more complex supply chains, there has been an increase in pharmaceutical cargo thefts and in drug counterfeiting. More preventative measures are therefore needed.

Industry will have a chance to comment on the proposed revisions once they are issued.

Note: On June 24, 2010, an FDA press officer clarified that the agency is “considering requiring finished pharmaceutical manufacturers to conduct on-site audits of the original manufacturers for components (i.e., ingredients) that they use in manufacturing.”

The End.

Digest Break – Quotes To Make You Think.

“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” — Henry Ford

“Make crime pay. Become a Lawyer.” — Will Rogers

“Few things are more satisfying than seeing your own children have teenagers of their own.” — Doug Larson

New FDA final guidance jump-starts track and trace.

This article courtesy of Stephen Barlas and Contract Pharma Magazine

The FDA’s publication of the final guidance on a standard numerical identifier (SNI) for pharmaceutical packages at the end of March awoke the drug industry from its track and trace slumber. Manufacturers, distributors, pharmacies and their vendors had been snoozing since September 2008, when California pushed back its e-Pedigree implementation date, an action with significant national implications. Instead of having to put unique serial numbers on packages starting January 1, 2011, California, responding to pleas from an ill-prepared drug industry, pushed back that e-Pedigree deadline to January 1, 2015. One-half of all drug packages arriving in the state on that date will have to have unique serial numbers printed on them. The other half will have to follow suit one year later.

“Everybody took a deep breath when the California Board of Pharmacy delayed its e-Pedigree requirement,” agreed Ruby Raley, director, healthcare solutions, Axway, a company that provides the software to run the data repositories that hold information about drug package pedigrees as an individual package moves from the manufacturer to (perhaps) a repackager to a wholesaler and on to the retail or hospital pharmacy. Axway is involved in numerous track and trace pilots with a number of major pharma companies. “Nothing happened last year,” she remarked.

Now, publication of an FDA-approved package serialization scheme has given the pharmaceutical industry a reason to restart its version of California Here I Come. Whereas the California Board of Pharmacy provided no specifics on package serialization, the FDA has; manufacturers no longer have to wait and guess what might be acceptable in the Golden State come January 1, 2015, a date that, given the complexities of e-Pedigree compliance, isn’t so far away.

James McCrory, vice president, products and technology at rfXcel Corp., said, “The SNI guidance is a big deal in three ways. It reflects new interest in federal government safety of prescription drugs, provides endorsement of GS1, which is pretty big since people have been hanging back waiting to see what happens, and matches what leaders and distributors and manufacturers are doing in their own pilots.” The SNI essentially endorses the serialization standard adopted by the international standards group GS1. GS1 has one serialization standard for numbers printed in 2D barcodes (GT10) and a second one for numbers printed on radio frequency identification (RFID) tags (G10).

An agreed-upon format for an item-level SNI is only the first step in a closed-loop e-Pedigree (often used synonymously with track and trace) system such as the one adopted by California, and likely to be endorsed by Congress. Other follow-on elements include:

Security framework for data exchange,

Record retention policies,

SNIs at the pallet and case level,

Standardized chain-of-custody data to be tracked by logistical units,

Standardized electronic data exchange format,

Data carriers with specific encoding formats identified,

Guidelines for reporting exceptions noted by supply chain participants, and

Hierarchy of the SNIs expected in a shipment.

The FDA SNI provides a first-step level of certainty to manufacturers, in terms of compliance with federal expectations, and assures them that the U.S. is moving in the same basic direction as other countries, many of whom are far more advanced in their national track and trace requirements. That is all true despite the limitations of the FDA guidance: it is a suggested package identification formula. There is no federal requirement that drug manufacturers follow it, much less put a serial number on each item-level package.

The limits of the FDA guidance, some of its nuances and its failure to address the important issue of which technology should be used to print the SNI have all combined, apparently, to seal the lips of pharmaceutical manufacturers who just three years ago were touting their track and trace efforts. Prominent proselytizers such as Pfizer, Abbott and Purdue Pharma have declined to comment on the FDA final guidance on an SNI. “I ran this request up the flag pole and have learned that we are unable to grant interviews on this topic,” explained Libby Holman, spokeswoman for Purdue Pharma, which has been an aggressive track and trace experimenter because of its manufacture of OxyContin, a popular target of drug diverters.

Tom McPhillips, vice president, U.S. Trade Group, Pfizer Inc., did not return an e-mail requesting comment. Mr. McPhillips, in his comments to the FDA after the draft guidance was published, asked the agency not to require manufacturers to print the national drug code (NDC) as part of both the machine readable and human readable SNI. The FDA rejected that request.

Nonetheless, manufacturers support the specificity of the SNI, and its agreement with GS1 standards, which gives them more certainty than California’s prescription for a unique serial number. The only guidance in the Golden State law, according to Virginia Herold, executive officer of the California Board of Pharmacy, is that the number be part of an “interoperable” track and trace system. The FDA-recommended SNI is a unique combination of two numbers printed on a package label that identifies the drug inside the package. The FDA final guidance specifies that half of the SNI is the national drug code (NDC), which is essentially unique for each drug made by each manufacturer, coupled with a unique serial number for the second half, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric or alphanumeric and should have no more than 20 characters. The SNI should be both machine and human readable.

The use of a GS1-compatible SNI means that manufacturers following the FDA guidance are very likely to comply with European, Brazilian, Norwegian and other national requirements for drug package serialization. Meanwhile, other countries are putting track and trace requirements into place, in some instances with more speed than the U.S. Ms. Raley explained that governments footing the bill for public healthcare (e.g. the EU, Brazil, Turkey) are especially concerned about counterfeit product sneaking into the country, since the government does not collect taxes on those transactions. “People are sneaking product in at the border, that is driving government concerns,” she explained.

In the U.S., the FDA has been more concerned about the prospective impact of counterfeit drugs on public health and safety. The 2007 Heparin recall underlined the value of track and trace (had it been deployed by the pharmaceutical chain) with regard to drug recalls. Preventing thefts is an important affiliate benefit, too. In March, thieves broke into an Eli Lilly warehouse in Enfield, CT and stole $75 million worth of prescription drugs. The crooks took pallets of the anti-cancer drugs Gemzar and Alimta, the schizophrenia drug Zyprexa, the antidepressant Cymbalta and other prescription medicines. Theoretically, those stolen drugs could not come back into the legal distribution chain if they had SNIs printed on 2D barcodes or RFID tags on each package’s label.

It is clear that manufacturers are the big winners, relatively speaking, from the final guidance. Scott Melville, senior vice president for government affairs for the Healthcare Distribution Management Association (HDMA), said, “The FDA guidance provides manufacturers and the entire pharmaceutical supply chain with needed clarity.” But while the HDMA has welcomed the guidance, it clearly did not get everything it wanted. For example, the HDMA had not wanted the FDA to endorse an “alphanumeric” as a serial number option.

However, Anita Ducca, senior director, regulatory affairs at HDMA, acknowledged the FDA was responsive to her group’s concerns. “We had a number of things we wanted the FDA to change from its draft guidance and for the most part the agency did that,” she states. “Our members are ready and willing to work within the parameters of the guidance.”

Neither did hospitals and pharmacies get exactly what they wanted. Some pharmacy groups had also pushed for a different SNI. The American Society of Health System Pharmacists (ASHP) had urged the FDA to modify the NDC number so that its components included the RxNorm CUI as the drug/form/ dose component of the code. Justine Coffey, JD, LLM, director, federal regulatory affairs, said, “Currently, ASHP members are struggling with inconsistencies relating to the National Drug Code (NDC) and its application to barcode point-of-care, clinical information systems, and hospital financial systems.”

Axway’s Ms. Raley noted that hospitals are particularly concerned about avoiding medication errors, especially given the passage of the health care reform bill, which mandates a number of new payment methodologies based on the hospital reducing errors of all kinds. She explained that many drugs come in many formulations and doses, information which will not be gleaned from the SNI endorsed by the FDA. Ms. Raley pointed out that hospitals are particularly sensitive to this issue given the publicity generated by the misadministration of Heparin to twins born in November 2007 to the actor Dennis Quaid and his wife.

Minor reservations aside, the HDMA’s Mr. Melville emphasized that the final guidance allows his members and everyone else to move forward. “The first step in an e-Pedigree system is putting a number on the package,” he said. “The second step is what you do with that number.”

For distributors a big issue is how the SNI is printed on the item-level package label. The two options that have emerged over the past half-decade are a 2D barcode or a radio frequency identification (RFID) tag. Distributors have generally favored RFID tagging, since they could check in packages to their warehouses without a reader having to be “in the line of sight” with the individual package. This saves them time, which is important because any e-Pedigree requirement costs the distributor money and earns the company no profit. But RFID tags are expensive, and manufacturers have generally pushed for printing serial numbers within 2D barcodes, not just because the labels are cheaper, but because the packaging lines can run faster than they could if RFID tags are printed on the package. Moreover, RFID tags cannot be used on some products.

The final guidance on the SNI appears, however, to endorse 2D barcode serialization without actually saying so. “The FDA landed on 2D,” stated Ms. Raley. “It is very clear they talked about the total acceptability of 2D although they did not rule out RFID.” RFID does have some significant shortcomings when it comes to package use, such as its deleterious effect on biologics.

Robert Celeste, director, healthcare, GS1 US, said that in fact all the manufacturers who have done pilots, and are doing them now, are putting serial numbers on packages via 2D barcodes. Some are also putting RFID tags on the product label, and on cartons and pallets. He believes it is possible that RFID tags on item-level packages may have utility – if their per unit price comes down – in certain applications, for example, where products must be kept at certain temperatures.

The final guidance, however, is silent on serialization of cartons and pallets, which the California Board of Pharmacy, just to cite one interested party, had pushed for, and on which the FDA had asked for comments.

While the pharmaceutical supply chain now knows that the SNI is the baseline for complying with California’s e-Pedigree requirement, everyone up and down the chain is pushing for federal legislation that would make the California requirement, or some close version of it, national law and might resolve outstanding technology questions as well. The 2007 congressional law that required the FDA to publish some sort of SNI within 30 months – it did not specify guidance versus more legal regulation – also told the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The FDA received comments but has done nothing to impose a technology solution, which various players in the drug distribution chain would probably oppose, but which is clearly necessary.

In the 2007-2008 session of Congress, Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced the Safeguarding America’s Pharmaceuticals Act, which would have established a federal e-Pedigree mandate. That law has not been reintroduced in the current Congress, perhaps, suggested Ms. Herold of California’s Board of Pharmacy, because members of the House and Senate have been overwhelmed with healthcare reform, financial reform and economic recovery. Also, the same sense of urgency that disappeared in California in September 2008 disappeared from Congress at about the same time.

As the HDMA’s Mr. Melville put it, “We want a uniform federal pedigree standard. We can’t have barriers to movement of products.” He added that Reps. Buyer and Matheson, at a hearing on March 10, stated they are working on a redrafted version of their bill. “We are very hopeful it will be reintroduced soon,” said Mr. Melville. “We expect it to look like the California implementation schedule.”

The End

Stephen Barlas is a freelance writer who has written several articles on pharmaceutical packaging for Contract Pharma. He can be reached at sbarlas@verizon.net.