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Editorial: Is Just One List Feasible? Part II

This is the twelfth in our series presenting various aspects of the new H.R. 3204 Drug Quality and Safety Act. This week, we will continue the discussion of the feasibility of having only one list of drugs; those that should not be used in compounding, while the remaining drugs and excipients can be prescribed and used in compounding. A drug that is moved to the negative list should follow the same procedure and standards as withdrawing a drug from the market due to safety, whether it is manufactured or compounded.

Last week, we listed the following drugs in the "all others" list that do not meet the requirement of being "FDA-Approved" or having a monograph in a compendia. Let's look at that list in a little more detail, as it may pose hardships if compounding is not allowed for some substances.

1. Pre-1938 drugs that have never been FDA-approved.
   *Of the 59 items listed in the "Pre-1938" Products, 8 have no USP monograph.
   Source: "Section IIII: Listing of "Pre-1938" Products". Approved Drug Products and Legal Requirements (USP DI 2004), 24th Ed. USP Drug Information, Volume III; III/1.
2. Drugs considered but not accepted for the positive list.
   *Not developed yet.
3. Investigational/study drugs
   *New drugs (new chemical entities-NCE's) are not FDA-approved and will not have USP monographs. Some studies at academic/clinical centers, etc. may use APIs that are not commercially marketed or have USP monographs. At least 70 pharmaceutical companies use compounding in some part of their IND/NDA process, and it has been very beneficial for many years.
   Source: Discussions at Innovation and Quality in Pharmaceutical Development- Consortium Workshop. February 2014. Washington, DC.
4. Orphan drugs
   *At the HRSA website, there are 262 pages of drugs the FDA has "designated" with orphan status. The vast majority of these do not have USP monographs. Compounding has been used to prepare these drugs for these patients for many years.
   Source: FDA website.
5. OTC drugs
   *According to the FDA website, OTC drugs are "not FDA-Approved." The OTC monograph system is a regulatory pathway for bringing an OTC drug product to market without FDA approval. There are over 300,000 marketed OTC drug products. There are over 80 therapeutic classes of drugs and for each category or class, an OTC drug monograph is developed. The OTC drug monographs are "recipes" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. In looking at the OTC Active Ingredients list, about 30% do not have USP monographs.
   Source: FDA Website.
6. Herbal/Some Dietary Supplement/Nutritional drugs
   *The USP has standards for a number of dietary supplements. This group is largely unapproved by the FDA with some having USP monographs.
   Source: USP 36-NF 31; FDA Website.
7. Miscellaneous

As mentioned above, it would be good to have only a "negative " list based on the premise that if a drug should not be used in compounding or manufacturing, it should be on the negative list; all others should be available for meeting physician and patient needs. This will require the development of only one list.


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

Shorter TV Ads May Trim Lengthy Side Effects
The FDA is studying whether disclosure of only serious side effects would improve consumer understanding. Advertisements are now required to carry warnings of side effects in their television commercials in the interest of full disclosure. However, it appears that these voiceovers confuse consumers and minimize the most dangerous risks, the agency said in its posting. The pharmaceutical industry spent $3.1 billion on DTC advertising in 2012.
http://www.bloomberg.com/news/2014-02-14/tv-drug-ads-may-trim-lengthy-recitation-of-side-effects.html?cmpid=yhoo

PHARMA Needs to Tell the Truth and Nothing but the Truth
PatientView survey respondents gave a thumbs-up to PHARMA's innovation and quality but weren't impressed with their marketing. Actually, their pricing policies came in last place in the patient-group approval contest, with just 13% of respondents saying that the industry's record on fair pricing was either good or excellent. But perhaps more worrisome is the fact that only 26% said they trust PHARMA's marketing to be ethical. That's down 8 percentage points just since 2011.
http://www.fiercepharmamarketing.com/story/win-over-patients-pharma-needs-tell-truth-and-nothing-expert-says/2014-02-18

Worries Abound on Drugs Made in India
India is the second-largest exporter of OTC and Rx drugs to the U.S.; it is coming under increased scrutiny by the FDA for safety issues, falsified drug test results, and for selling fake medicines. India supplies 40 percent of OTC and generic Rx drugs consumed in the U.S. FDA investigators are inspecting more Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants.

Using the new revenue, the FDA has tried to increase its staff in China, but the Chinese government has failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joe Biden. The U.S. has become so dependent on Chinese imports now that the FDA may not be able to do much about the Chinese refusal. The critical ingredients for nearly all antibiotics, steroids, and many others are now made exclusively in China.
http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?_r=0

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When Peter Piper,
Pickle picker,
Kissed his gal,
His beard
Would prick'er!
     Burma Shave

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

Doc Lane's Veterinary Pharmacy, LLC, Lexington, Kentucky; Anne Gresham, RPh, anne@doclanes.com. Initial Accreditation for Sterile & Nonsterile Compounding

Broadway Apothecary, Eugene, Oregon; Kate James, RPh, katiejamesrph@yahoo.com. Re-Accreditation for Nonsterile Compounding

Richie's Pharmacy and Medical, Conroe, Texas; Richie Ray, RPh, richie@richiespharmacy.com. Re-accreditation for Nonsterile Compounding

Needed: Compounding Pharmacist
Grove Pharmacy, Springfield, MO is seeking a Compounding Pharmacist. This position requires compounding knowledge, clinical skills and drug resource abilities. Responsible for daily operations, overseeing technicians, documentation, policies, procedures, and provides great customer service. Knowledge in USP 795 and USP 797 are required. Contact Winn Jester wjester@grovepharmacy.com (417)881-8822