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Editorial: Differentiating "Manufacturing" from "Compounding"!

The differentiation of manufacturing from compounding has been the subject of debates for at least 10 to 15 years at both state and federal levels. Let's look at the USP definitions and then determine what can be considered as "differentiating factors" between the two.

The USP defines "manufacturing" as "The production, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis."

The USP defines "compounding" as "The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice."

It is evident from the above definitions that the most visible differentiation is that compounding involves the practitioner/patient/pharmacist/compounder relationship. In the past, pharmacists have also compounded for "office use" which, even though outside the actual definition, has been recognized as necessary and valuable. In fact, the concept has been expanded to include cardioplegia solutions, and other items for use in surgery and other hospital and clinic departments, etc. that are not "patient-specific," but necessary.

Recently, we have had the situation involving an extremely large number of drug products in short supply. The only resource available to provide patients with necessary and life-saving medications has been through compounding. This has even involved commercial products that the FDA has approved of compounding during the time of need, for example Tamiflu suspension. Many state boards of pharmacy have allowed this, as it was necessary. However, it is still outside the realm of traditional "office use" compounding and has placed some pharmacies in the category of "manufacturers" by some state boards of pharmacy.

So, despite all the hours (and days) of discussions in trying to differentiate between a manufacturer and a compounder, I would like to pose the following differentiation.

Greek Pharmaceutical Companies Accused of Cutting Supplies
Hundreds of drugs are in short supply in Greece, and the situation is getting worse. The government has drawn up a list of more than 50 pharmaceutical companies it accuses of halting or planning to halt supplies because of low prices in the country.

More than 200 products are affected; these include treatments for arthritis, hepatitis C, and hypertension, cholesterol-lowering agents, antipsychotics, antibiotics, anesthetics, and immunomodulators used to treat bowel disease.

Also, the Swiss Red Cross is reducing its supply of donor blood to Greece because it had not paid its bills on time. Pharmacists in Athens describe chaotic scenes with desperate customers going from pharmacy to pharmacy to look for prescription drugs which hospitals could no longer dispense.
http://www.guardian.co.uk/world/2013/feb/27/greece-blames-drug-companies-shortages

Administration Now Says States Can Cut Back on Medicaid Payments
The Obama administration announced that states could cut Medicaid payments to many doctors and other healthcare providers to hold down costs in the program, which insures 60 million low-income people and will soon cover many more under the new healthcare law. This position has broad national implications, as it comes as the White House is trying to persuade states to expand Medicaid as part of the new law. The statement has infuriated healthcare providers and advocates for low-income people.
http://www.nytimes.com/2013/02/26/us/politics/states-can-cut-back-on-medicaid-payments-administration-says.html?ref=todayspaper&_r=0

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�that you can be taken advantage of if you are not knowledgeable about issues that affect your practice?

Study USP <795>, <797>, <1163>, and related chapters to become familiar with their contents so you will be better prepared if issues arise.

A scratchy chin,
Like bright pink socks,
Puts any romance
On the rocks!
      Burma Shave

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

Highland Pharmacy, Albuquerque, NM; Teri Rolan, PharmD, tmrolan@highlandpharmacy.com; Initial Accreditation for Sterile and Nonsterile Compounding

Myers Drug, Inc., San Angelo, TX; Doug Chadwick, RPh, myers1@myersdrug.com; Initial Accreditation for Sterile and Nonsterile Compounding

Vernak Farms Country Store, Skaneateles, NY; Charlene Vernak, RPh, vernakfarms@gmail.com; Initial Accreditation for Nonsterile Compounding

Owens Compounding Pharmacy, Redding, CA; Aaron Smith, PharmD, asmith@owenshealthcare.com; Initial Accreditation for Nonsterile Compounding

People's Custom Rx & Clinical Care, Memphis, TN; William Johns, PharmD, bjohns@peoplescustomrx.com; Initial Accreditation for Sterile and Nonsterile Compounding