The rising popularity of bioidentical hormones, HCG-based weight loss protocols, and chelation has fostered a resurgence of compounding pharmacies in recent years. But in the minds of some doctors, these labs are a poorly regulated throwback to a more primitive epoch of medicine.
Compounding pharmacists provide tremendous value, offering a wide range of drugs and nutraceuticals in flexible formulations impossible to obtain from commercial drug makers. They also provide safe, well-validated forms of hormones or other substances that patients, left to their own devices, will try to buy from questionable online suppliers.
Compounding pharmacies are regulated by a patchwork of state and federal rules, with state boards providing local enforcement of national standards set by the US Pharmacopeia. Stringency of enforcement varies from state to state: some are slack, others are strict, a few are downright oppressive.
It is standard practice for compounding pharmacies to obtain certificates of analysis (C of A) documenting identity and purity of all raw materials. Florida is among a handful of states requiring suppliers to provide ingredient pedigrees.
“Every time we purchase something like human chorionotropic gonadotropin (HCG), we get a pedigree telling us exactly where it originates from. And then we do our own testing to make sure it is what the package says it is,” said Mark Rubin, RPh, president and head pharmacist at Royal Palm Compounding Pharmacy, Wellington, FL (www.royalpalmcompoundingpharmacy.com). “I can’t buy from a supplier who does not follow the pedigree rules.”
Mr. Rubin said Florida is working hard to weed out poor quality, black market ingredients from the drug and nutraceutical supply chain. He urged physicians to do more due diligence with compounders. “We send the C of As to our doctors, whether they ask for them or not. And we’re happy to provide the pedigree information, too, if they want it.”
The Professional Compounding Centers of America (www.pccarx.org) an industry trade and education group, has established exhaustive standards for quality control. PCCA validates, repackages and resells hundreds of compounds to independent pharmacies, and pools knowledge & skill, offering members guidance on difficult, unusual or obscure formulations.
“They provide tremendous assistance and technical support,” said Jerry Gillick, RPh, president and pharmacy manager of College Pharmacy, Colorado Springs (http://www.collegepharmacy.com/). Physicians should ask compounding pharmacies if they are members. Because the membership fee is high, PCCA attracts only those companies that are serious, ethical and committed to quality.
The other major trade group is the International Association of Compounding Pharmacists (http://www.iacprx.org/), which is focused on establishing reasonable, consistent regulation without unnecessary trade restrictions.
Mr. Gillick described the current regulatory landscape as “a total mess.” Pharmaceutical lobbyists are constantly pressuring the FDA to declare compounders to be “drug manufacturers,” putting them under federal rather than state oversight.
The issue came to a head a few years ago, when FDA followed a prompt from Wyeth to declare compounded estriol a “new drug.” Wyeth’s Citizen’s Petition called estriol “a serious threat to public health,” though the company itself markets estriol in Europe. Congress prohibited FDA from enforcing an all-out estriol restriction, but the issue remains contentious.
Mr. Gillick believes good regulation is essential. But too often regulators make life difficult for ethical pharmacies while ignoring real public health threats. “What are they doing to regulate off-shore pharmacies and mail order companies that have no quality control at all?”
