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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 9

This week, we will summarize Subpart G: Packaging and Labeling Control. The following are the subpart sections and a brief description of their content.

Sec. 211.122 Materials Examination and Usage Criteria
This section requires written, detailed procedures on the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials which must be followed. Detailed procedures are required to ensure total control and accountability of all labels.

Sec. 211.125 Labeling Issuance
Labeling shall be reconciled and any discrepancies must be investigated and resolved. Any excess labels will be destroyed.

Sec. 211.130 Packaging and Labeling Operations
Procedures include the prevention of mix-ups and cross-contamination by physical or spatial separation from operations on other drug products. Complete identification and examination/inspection activities are required and must be documented.

Sec. 211.132 Tamper-evident Packaging Requirements for Over-the-counter (OTC) Human Drug Products
Requirements for tamper-evident packaging are detailed for OTC drug products.

Sec. 211.134 Drug Product Inspection
Finishing operations require that packaged and labeled products be examined and the results recorded on the batch records.

Sec. 211.137 Expiration Dating
Drug products must bear an expiration date that has been determined by appropriate stability testing. The expiration date is related to storage conditions stated on the labeling. If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products. Homeopathic drug products are exempt from this requirement. New drug products for investigational use are exempt from this requirement provided they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations.


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

FDA Head Proposes Charging Compounding Pharmacies for Oversight
FDA Commissioner Margaret Hamburg has proposed charging compounding pharmacies fees to pay for the oversight needed to prevent a recurrence of the meningitis outbreak that killed 50 people and sickened hundreds more. She said a possible mechanism for funding the additional oversight could include registration or other fees of the kind Congress has authorized in other instances. Pharmaceutical companies, for example, pay fees to help fund the FDA's drug review process.
http://www.reuters.com/article/2013/03/22/us-usa-health-meningitis-idUSBRE92L17G20130322

Massachusetts Halts Drug Production at Woburn Pharmacy
Inspectors found foreign matter in vials of injectable drugs made by a Woburn compounding pharmacy that regulators had previously cited for a series of problems. After the inspection found the contamination, the company, Pallimed Solutions Inc., immediately recalled more than a dozen products distributed in 15 states since Jan. 1. No reports of patient injuries have been received in the latest incident. The company also was ordered to stop making a generic form of Viagra last November after a surprise inspection found it was being made with "improper components."
http://bostonglobe.com/lifestyle/health-wellness/2013/03/25/woburn-compounding-pharmacy-issues-recall-sterile-products/j7QDTvv5WIHO1FU8W6mNGP/story.html

Hospira Inspection Report Details Ongoing Problems
The FDA has dashed the hopes of Hospira that its Rocky Mount, North Carolina, plant was finally out of the woods when it handed executives a 21-page inspection report detailing 20 observations, many of them with multiple points. Observations included (1) seeing substantial amounts of debris around conveyors, (2) written procedures that were not followed, (3) employees on the parenteral filling area that couldn't recognized defects, (4) employees that couldn't keep up with manual inspections, (5) problems with cleaning in the aseptic processing area, and (6) problems with making sure that defective solution bags were taken out of production. Also, while inspectors were in the plant, the company issued three recalls of 5 different products, some after customers found either a loose crimp or no crimp on the flip-top vials.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobal
RegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM344785.pdf

Formal Investigation into French Drug Regulator
French magistrates looking into whether a diabetes drug caused deaths have put the country's drug-safety agency under formal investigation for alleged involuntary manslaughter, widening their criminal probe beyond the French company that developed and sold the medication. The investigating magistrates are seeking to determine whether the agency neglected multiple alerts over a 14-year period that a drug was potentially dangerous. French authorities withdrew the drug from the market in 2009.
http://online.wsj.com/article/SB10001424127887323419104578372702793767028.html?cb=logged0.5628836266500254

BD Enters Pharmaceutical Industry with New Line of Injectable Products
Becton, Dickinson and Company (BD) has announced that the FDA has approved the first drug to be offered in the just-launched BD Simplist ready-to-administer, line of prefilled generic injectables. The first BD Simplist product BD will launch is Diphenhydramine Hydrochloride Injection USP. BD Rx plans to launch 20 to 30 drugs in BD Simplist prefilled injectables over the next few years.
http://www.fiercepharma.com/press-releases/bd-enters-pharmaceutical-industry-new-line-generic-prefilled-injectable-pro?utm_medium=nl&utm_source=internal

Pricing Data Requested by Drugstores
The shift to generic drugs has saved consumers more than a $1 trillion over a decade in the U.S., but has taken a heavy toll on independent pharmacists. However, the middle-men (PBMs) are doing very well. These small businesses/drugstores are turning to state legislators across the country for help against powerful middlemen that determine how much drugstores are reimbursed for certain medicines; currently, eight states, including Oregon, are considering such legislation. The drugstores want lawmakers to require the middlemen to turn over arcane pricing data that would help drugstores negotiate bigger reimbursements and avoid dispensing drugs that are money losers, pharmacies argue. National chains (Walgreen Co., Rite Aid Corp) would also stand to benefit by law changes, though the stakes for them are lower because they buy drugs more cheaply than mom-and-pop operators.
http://online.wsj.com/article/SB10001424127887323466204578382990730159644.html?cb=logged0.29291001967469776

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�that Easter, the celebration of Jesus Christ's resurrection from the dead, is Christianity's most important holiday. It has been called a moveable feast because it doesn't fall on a set date every year, as most holidays do. Instead, Christian churches in the West celebrate Easter on the first Sunday following the full moon after the vernal equinox on March 21. Therefore, Easter is observed anywhere between March 22 and April 25 every year. Orthodox Christians use the Julian calendar to calculate when Easter will occur and typically celebrate the holiday a week or two after the Western churches, which follow the Gregorian calendar.

In addition to Easter's religious significance, it also has a commercial side, as evidenced by the mounds of jelly beans and marshmallow chicks that appear in stores each spring, many of which are purchased at local pharmacies and drug stores. As with Christmas, over the centuries various folk customs and pagan traditions, including Easter eggs, bunnies, baskets, and candy, have become a standard part of this holiday.

Use our cream
And we betcha,
Girls won't wait,
They'll come and getcha!
      Burma Shave

The APhA now has a Compounding Special Interest Group. With your "APhA" member number handy, go to the following to enroll and participate.

http://fs10.formsite.com/APHA-APPM/form78/index.html

For Sale:
Shimadzu Electronic Balance Model TX323L/Little used - $900
Reference Books: USP Second Edition; Veterinary Drug Handbook: Client Information; Ghen and Rain's Physician's Guide to Pharmaceutical Compounding; Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems; Trissel's Stability of Compounding Formulations; and many more.
Lee V. Griffin Rxpert.griffin@gmail.com