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Editorial: Summary Effects of H.R. 3204, Part II (503A)
This week, we will summarize the requirements for 503A, which possibly affects more than an estimated 99% of the pharmacies in the U.S., most of which do some traditional compounding.
- FDA expects State Boards of Pharmacy to continue their oversight and regulation of the practice of pharmacy, including traditional pharmacy compounding.
- FDA intends to continue to cooperate with State authorities to address pharmacy activities that may be violative of the FD&C Act, including section 503A.
- A drug must be compounded for an identified, individual patient based on the receipt of a valid prescription order, or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient.
- The compounding of the drug product is performed:
- By a licensed pharmacist in a State licensed pharmacy or a Federal facility, or by a licensed physician on the prescription order for an individual patient; or
- By a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient when there is documentation of need.
- The drug is compounded in compliance with the United States Pharmacopeia (USP) chapters on pharmacy compounding using bulk drug substances (Active Pharmaceutical Ingredients -APIs) that:
- complies with the standards of an applicable USP or National Formulary (NF) monograph, if one exists.
- If such a monograph does not exist, the drug substance(s) must be a component of an FDA-approved human drug product.
- If a monograph does not exist and the drug substance is not a component of an FDA-approved human drug product, it must appear on a list of bulk drug substances for use in compounding developed by FDA through regulation.
- The drug product is compounded using bulk drug substances that are:
- manufactured by an establishment that is registered (including a foreign establishment).
- accompanied by valid certificates of analysis for each bulk drug substance.
- The drug product is compounded using excipients that comply with the standards of an applicable USP or NF monograph, if one exists, and the USP chapters on pharmacy compounding.
- The drug product does not appear on the list of drug products that have been withdrawn or removed from the market that have been found to be unsafe or not effective.
- Drug products that are essentially copies of commercially available products are not compounded regularly or in inordinate amounts.
- Drug products listed by the FDA that present demonstrable difficulties for compounding or that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product are not compounded.
- The drug product is compounded in a State that has entered into a memorandum of understanding (MOU) with FDA that addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or in States that have not entered into such an MOU with FDA, the licensed pharmacist, licensed pharmacy, or licensed physician does not distribute, or cause to be distributed, compounded drug products out of the State in which they are compounded, more than 5% of the total prescription orders dispensed or distributed by such pharmacy or physician.
Next week, as we continue this series, we will look at the activities the FDA is initiating and will continue to undertake in the future.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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K-V and Makena Back!
K-V's lawsuit claiming U.S. regulators allowed "unlawful competition" to its Makena drug was revived as a federal appeals court ordered a lower-court judge to reconsider a ruling against the company. K-V lost its bid in 2012 in federal court to force the FDA to block compounding pharmacies from producing a less expensive version of Makena. The FDA declined to block the pharmacies from compounding the drug after K-V obtained rights to Makena and initially raised the price from $20 a dose to $1,500. The company stated it was irreparably harmed by the FDA failing to enforce its drug-marketing exclusivity for Makena. The company emerged from bankruptcy in New York in September. A three-judge panel of the U.S. Court of Appeals in Washington ordered U.S. District Judge Amy Berman Jackson to reconsider her ruling against the company in light of a 2013 decision by the court involving the FDA and the Drug Quality and Security Act.
http://www.bloomberg.com/news/2014-01-07/k-v-pharmaceutical-suit-over-makena-drug-revived-by-court-1-.html
http://www.fiercepharma.com/story/kv-gets-second-shot-forcing-fda-restrict-compounders-makena/2014-01-10?utm_medium=nl&utm_source=internal
FDA Pushing State Agencies to Register Compounding Pharmacies
The FDA commissioner has sent letters to state agencies and other stakeholders calling on them to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public.
http://www.washingtonpost.com/national/health-science/states-urged-to-register-compounding-pharmacies/2014/01/10/d7888df4-7a1d-11e3-a647-a19deaf575b3_story.html
FDA and Ranbaxy
The FDA has raised concerns about the manufacturing practices at another factory owned by Ranbaxy Laboratories Ltd in India. Now, all of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the U.S. after inspections found violation of its GMPs.
Also, the FDA has filed observations about the Toansa pharmaceutical raw ingredients plant in the northern state of Punjab. Failure to address these concerns would result in the FDA banning all exports to the U.S. from the factory.
http://www.reuters.com/article/2014/01/13/ranbaxy-india-fda-idUSL3N0KN1PP20140113
Former Vice President of Sinopharm Held on Corruption Claim
A former VP of China's biggest drug distributor, Sinopharm, has been detained by Shanghai authorities as part of a probe into a corruption allegation against the executive. A whistle-blower has accused two executives of misappropriating company funds and setting up illegal personal accounts.
China continues to expand a crackdown on corruption in the healthcare industry that began in July and has led to the arrest of some executives at GlaxoSmithKline and probes into doctors and medical workers; recently the country's National Health and Family Planning Commission announced a blacklist of drug companies found to have been engaged in commercial bribery.
http://www.bloomberg.com/news/2014-01-13/sinopharm-says-former-vice-president-held-on-corruption-claim.html
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