Criticism

The FDA and others say that the larger compounding pharmacies are acting like drug manufacturers while circumventing FDA regulations. Compounding pharmacies are manufacturing and distributing drugs, but there is little FDA regulation. Instead, they are regulated by state agencies, whose regulations are not as strict. Drugs from compounding pharmacies can be much cheaper, but contaminated drugs have been traced back to compounding pharmacies. Compounding pharmacies have been regulated by laws that were developed when they made custom prescriptions for patients with special needs, but now they have become "miniature drug companies." Lawyers critical of the pharmacies say that large-scale compounders often behave like manufacturers, with sales teams that market to doctors, without following FDA regulations, circumventing the regulatory process.^[1][21]

Regulation in Australia

In Australia there is no regulatory board that governs how and where a Pharmacist compounds medications. It is very important for consumers to choose their Australian Compounding Pharmcies carefully as they are all self regulated. The only guidelines that need to be followed are by the Pharmacys governing body – The Pharmacy Board – where the only regulation is that a compounded product be prepared on an individual basis (not manufactured) and they follow the Professional Practice Standards – Section 10.^[22] Since compounding has grown in popularity, the highest quality compounding chemists are self regulated. Compounding Chemists Australia,^[23] is a website devoted to ensuring they only list reputable compounding chemists. It is not uncommon to find compounding being performed in the pharmacy's back room near the kitchen sink, however, this is not illegal. Sterile compounding and non-sterile compounding have different requirements. For sterile compounding, the use of a laminar flow hood or vertical flow hood must be used. In non-sterile compounding, including most topical compounded medications, a hood is not required and does not adversely effect potency or quality of the final product.

See also

• Apothecary — the ancestral practitioner of compounding, and his shop

• Bioidentical hormone replacement therapy — Compounding is involved in the surrounding controversy

• Professional Compounding Centers of America

• New England Compounding Center meningitis outbreak

References

1. ^ ^{a b} Grady, Denise; Pollack, Andrew and Tavernise, Sabrina (2012-10-07). Scant Oversight of Drug Maker in Fatal Meningitis Outbreak. New York Times.

2. ^ Meningitis outbreak toll: 119 cases, 11 deaths. Usatoday.com (2012-10-09). Retrieved on 2012-12-19.

3. ^ Morgan, David. "Health officials knew of problem steroids in 2002: U.S. House panel". CNBC. http://www.cnbc.com/id/49511024. Retrieved 23 October 2012.

4. ^ ^{a b} Burtin, T. M.; Grimaldi, J. V. and Martin, T. W. (2012-10-14). Pharmacies Fought Controls; Industry at the Focus of Meningitis Outbreak Beat Back More Federal Oversight, Wall Street Journal

5. ^ Information taken from the abstract of Hadzović, S (1997). "[Pharmacy and the great contribution of Arab-Islamic science to its development] (Article in Croatian)". Medicinski arhiv 51 (1–2): 47–50. ISSN 0350-199X. PMID 9324574.

6. ^ Sharif Kaf al-Ghazal, Journal of the International Society for the History of Islamic Medicine, 2004 (3), pp. 3–9 [8].

7. ^ Cdc – Hai. Cdc.gov. Retrieved on 2012-12-19.

8. ^ ^{a b} "International Academy of Compounding Pharmacists: Definition of Compounding". http://www.iacprx.org/site/PageServer?pagename=What_is_Compounding. Retrieved 2010-07-18.

9. ^ "ArmourThyroid". http://www.armourthyroid.com/. Retrieved 2010-07-17.

10. ^ "Options for thyroid treatment | Stop The Thyroid Madness". http://www.stopthethyroidmadness.com/options-for-thyroid-treatment/. Retrieved 2010-07-17.

11. ^ "www.fda.gov". http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm137148.htm. Retrieved 2010-07-18.

12. ^ Boothby LA, Doering PL (August 2008). "Bioidentical hormone therapy: a panacea that lacks supportive evidence". Curr. Opin. Obstet. Gynecol. 20 (4): 400–7. doi:10.1097/GCO.0b013e3283081ae9. PMID 18660693.

13. ^ "5-in-1 PolyPill Treatment May Prevent Heart Disease". Bayviewrx.com. 2009-04-01. http://www.bayviewrx.com/bayview-blog/bid/18766/5-in-1-PolyPill-Treatment-May-Prevent-Heart-Disease. Retrieved 2012-02-05.

14. ^ ^{a b c} The Special Risks of Pharmacy Compounding. Fda.gov (2012-12-03). Retrieved on 2012-12-19.

15. ^ "International Academy of Compounding Pharmacists: Frequently Asked Questions". http://www.iacprx.org/site/PageServer?pagename=FAQs. Retrieved 2010-07-18.

16. ^ Thompson v. Western States Medical Center (535 U.S. 357, 2002). law.cornell.edu

17. ^ "Medical Center Pharmacy v. Mukasey". Fda.gov. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm. Retrieved 2012-02-05.

18. ^ "Importation of Active Pharmaceutical Ingredients (APIs) Requirements CPG 460.200 Pharmacy Compounding Compliance Policy Guides Manual (Tab M)" (PDF). http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM118050.pdf. Retrieved 2012-02-05.

19. ^ ^{a b} "American Society of Health-Systems Pharmacists: Statement on the Use of Medications for Unlabeled Use". http://www.ashp.org/DocLibrary/BestPractices/FormStUnlabeled.aspx. Retrieved 2012-04-04.

20. ^ ^{a b} Bogdanich, Walt and Tavernise, Sabrina (2012-10-22). U.S. Concern Over Compounders Predates Outbreak of Meningitis. New York Times.

21. ^ Martin, T. W.; Burton, T. M. and Dooren, J. C. (2012-10-09). "Outbreak Spurs Calls for New Controls". The Wall Street Journal. The Wall Street Journal. http://online.wsj.com/article/SB10000872396390443982904578044682649925200.html?mod=WSJ_hpp_LEFTTopStories. Retrieved 9 October 2012.

22. ^ "Professional Practice Standards VERSION 4 2010" (PDF). http://www.psa.org.au/download/standards/professional-practice-standards-v4.pdf. Retrieved 2012-02-05.

23. ^ "Compounding Chemists Australia". Compoundingchemists.com.au. http://www.compoundingchemists.com.au. Retrieved 2012-02-05.