Threat to Compounding of Topical Testosterone, Other Pharmaceuticals: FDA Proposes Limit on Interstate Shipment
"Compounding" means that a pharmacist or physician custom-mixes a drug according to an order from a physician, instead of dispensing medication which has been mass produced. Originally most prescriptions were filled by compounding; today, few are. AIDS Treatment News twice noted the availability of compounded drugs: DHEA in 1996, before it was widely sold in the U.S., and testosterone last year during a supply shortage of the approved generic injectable forms, since topical cream and gel formulations remained available at little cost from compounding pharmacies, and may be more suitable than testosterone injections or patches for some patients.The FDA Modernization Act, the reform law currently in effect, requires the FDA to draft a "memorandum of understanding" (MOU) on compounding, to be signed by each state; the purpose of this section seems to be to impose more uniform regulation of compounding by the states. The current controversy concerns a provision of the FDA's draft MOU that would prevent a pharmacy or physician from filling more than 20% of its compounded prescriptions out of state. This provision will make it difficult for some patients to obtain the medicine their doctor recommends.
Apparently the FDA is concerned about how to draw a line between compounding and manufacturing (which is subject to higher regulatory standards of quality control). The fear seems to be that some pharmacies could use the compounding exception, which was "grandfathered" into current practice years ago, to set up manufacturing not subject to all of the usual safeguards. The limit on out-of-state shipments seems designed to choke the compounding industry and keep it small.
We are concerned that this limit may be both unnecessary and harmful. Compounding is unlikely to encroach significantly on drug manufacturing, since there is seldom an incentive to compound drugs unless they are otherwise unavailable. And the arbitrary limit proposed will impact patients directly, since it only works by blocking them from obtaining treatments their physicians want them to have.
For background, see the FDA's Web page on this issue, http://www.fda.gov/cder/ Note the link to the "Draft MOU"; also note the link to Section 127 of the FDA Modernization Act. Also see the Women's International Pharmacy site, www.wipws.com, which includes suggestions on how to oppose the out-of-state prescription limits.
AIDS Treatment News submitted the following letter to the FDA last week. We did not learn about the issue until shortly before the public comment period closed on May 31.
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, Maryland 20852
Re: Docket No. 98N-1265
The 12/23/98 Draft Memorandum of Understanding on Interstate Distribution of Compounded Drug Products, in its current form, threatens access to important medications for some persons with AIDS and other illnesses.
Last November AIDS Treatment News investigated a serious shortage of FDA-approved injectable testosterone, apparently the unintended result of an FDA enforcement action against a manufacturer (see "U.S. Testosterone Shortage: Call for Information," AIDS Treatment News #306, and "Testosterone Cream and Gel Available; Prices Vary Widely," Issue #307; both are available at www.aids.org/atn). Many patients and physicians were unable to obtain the products they had been using, or a suitable equivalent. As one alternative, we investigated compounded testosterone cream or gel for topical use. We found a more than 10-fold difference in price, and fortunately were able to locate a reliable compounding pharmacy which could supply these products for $20 per month.
The 20% ceiling on out-of-state shipment of a compounded drug (in the 12/23/98 Memorandum of Understanding) is likely to make reliable products much harder to obtain. This figure is not included in legislation, and was apparently picked arbitrarily. It will mean that patients will rely on less experienced compounders, or will need to travel to other states to obtain their medication.
A "memorandum of understanding with the FDA that addresses the interstate distribution of inordinate amounts of compounded drug products" does not require an arbitrary ceiling or other provisions which will make it difficult for patients to obtain necessary care.
Sincerely yours,
John S. James
Editor and publisher, AIDS Treatment News
