Prescription Drug Safety: Emergency Controls, Scams and Long-distance Sales

States Maintain Pharmacy Emergency Regulation & Price Gouging Laws

Updated: April 2009

Each time there is a public health-related emergency -- rising concerns about swine flu, smallpox, avian flu and other devastating diseases or Hurricane Katrina and the earlier Anthrax bioterrorism incidents -- growing media and public attention focus on timely access to medicines that can prevent, treat or alleviate such diseases, as well as potential chemical or radiological exposure. Consumer concerns or even panic over these threats can lead to inappropriate use of antibiotics and attempts to stockpile or hoard medicines.

State governments play important roles concerning prescription drugs, from ensuring availability of medicines in cases of emergency for those who need them to regulating consumer use. State policymakers also may help inform consumers about both appropriate and inappropriate use of medicines, and guard against illegal activities. 

Regulating pharmaceuticals:  States and the federal government regulate prescription drugs through prescribing authority, purchasing restrictions, quality controls, and by limiting unscrupulous practices. Although these regulatory activities do not explicitly address bioterrorism events, they may complement such activities. Understanding existing regulations may be useful for policymakers in planning for emergency response needs.

Almost all product purchases are restricted by law:  Pharmaceutical products such as Cipro®, ciprofloxacin, doxycycline and virtually all antibiotic products are prescription drugs (sometimes termed "legend drugs"), which means legally, under state and federal law, they may be purchased or obtained only via a written prescription, signed by a physician or other authorized prescriber. Certain vaccines may be administered to members of the public upon signing a consent form, without an individual prescription. However, no individual in the United States may purchase such prescription drugs or vaccines "over-the-counter." Doctors and other authorized prescribers are directed by laws and medical ethics guidelines to prescribe such medicines only 1) when they are medically necessary and 2) only in the quantity required for individual treatment. Any hoarding or stockpiling of such drugs by individuals is likely to involve an illegal act. Virtually all authorized prescribers are well aware of the negative medical and societal consequences of unnecessary or excessive prescription approval. Authorized prescribers who violate prescribing regulations or medical guidelines may be subject to discipline by a state Board of Medicine.

Role of public health officials:  In cases of a "public health emergency," local, state or federal health officials may recommend or authorize that groups of individuals at risk be given medication such as antibiotics. This may occur without the need for individual prescription forms that normally are specified by state law and pharmacy board regulations. See Appendix below for official CDC advice and guidelines. In addition some public health experts are suggesting a significantly expanded role in the future and have drafted model legislation that is currently under review. See details at Model Act.

The wholesale market is partly self-regulated:  Physicians, pharmacies, and associated institutions such as hospitals may order or purchase wholesale quantities of prescription drugs. Traditionally, medical necessity and the commercial market have combined to establish a predictable flow of products from raw materials to manufacturers to wholesalers to the retail outlet. This largely unregulated professional structure was challenged in 1999 by the "Y2K threat," with fears of computer breakdowns leading to some suggestions of stockpiling by providers and even by the public "just in case." Some physicians wrote prescriptions for 60 or 90 day supplies as a precaution. Several states considered legislation mandating or allowing these somewhat larger purchases as a precaution, but no mandatory laws were enacted, in part because of industry concerns that supplies and shelves would be emptied strictly by the "fear" factor, and that those in need might be unable to get their medicines. Pharmaceutical manufacturers and suppliers created some plans and adjustments to minimize adverse impacts. In the end there were no reported shortages nor was stockpiling or hoarding a real problem. Of course the Y2K situation potentially affected most if not all of the thousands of prescription drugs, while the post-September 11 bioterrorism situation so far is focused on a few individual products.

Flu Vaccine Shortages in 2004; Avian Flu Fears in 2006

The unexpected announcement in fall 2004 that the U.S. faced a shortage of about 48 million doses of the influenza (flu) vaccine had fast evolving impacts at the state level.  While the issues of manufacturing safety and coordination are substantially federal functions through the FDA and CDC, states have the power to address issues of "unfair practices" and price gouging.  In addition to the post 9/11 "Emergency Powers" laws listed later in this report, at least 18 states have general consumer laws addressing certain price gouging, including pharmaceuticals. 

Brand name vs. generic products: In 2001, news headlines focused on Cipro^®, a "single-source" brand name product versus less-expensive generic versions. Federal patent law and the Food and Drug Administration (FDA) control the actual legal availability of individual products in the United States. For ciprofloxacin, the only product legally available in the United States is the name-brand product marketed as Cipro by Bayer. Each nation establishes separate patent laws, so in many other locations a generic version is legally available. Also some nations have less restrictive laws regarding doctor-signed prescriptions, so it may be legal to purchase items as "over-the-counter" products. For example, Mexico law defines many U.S. prescription products as unrestricted for purchase. In Canada, those same products are treated as prescription-only purchases. Patent law is a federal matter, not generally subject to state regulation. The Center for Policy Analysis argues that "weakening patent protection (e.g., by government violation of patents) may have a chilling effect on private R&D investment, and therefore reduce the health and wealth of future generations."

Internet and individual importation:  Unrelated to the events of 2001, there is a substantial debate about the role, desirability and legality of prescription drug transactions outside the traditional, regulated U.S. prescription system. The FDA has for years maintained a policy that lets patients bring a small amount (such as a 90-day supply) of non-FDA approved drugs into the U.S. "for compassionate use." ⁽⁴⁾ This means that individuals who travel to countries like Canada or Mexico may purchase pharmaceuticals for personal use at the price available, and without a prescription if that is the law of that country.

In addition, a growing number of pharmaceuticals are shipped from U.S. based businesses or from foreign countries via the mail, after being purchased from pharmacies operating over the Internet. In practical terms, such transactions fall into three categories:

1) Legitimate medical and financial transactions: These purchases begin with a prescription for a patient signed by a U.S. physician and conclude with the delivery of an authentic product made by a reputable manufacturer, either brand-name or generic. The company making the sale may or may not be a licensed retail pharmacy.

2) "Irregular" transactions: These often are not based on a signed prescription authorization form and may be filled by an "offshore" e-retailer that is not necessarily regulated by any individual nation's laws. This is the category likely to be used by individuals seeking to "stockpile," hoard or resell drugs, since the usual restrictions would not be in operation. In this category example, the product itself may be legitimate, but it may be inappropriate or even dangerous to take without medical advice. According to the Congressional Research Service, these kinds of transactions are "a major concern of both FDA and the Customs Service," but reportedly most are not seized or detained. "The FDA's concern is that government inspectors cannot, with any assurance, determine whether the products being shipped are safe." ⁽⁴⁾

3) Scams and Internet black market products which may be illegal and dangerous:  Unfortunately the Internet and related e-mail systems provide easy and inexpensive tools for dishonest operators to defraud the public, with potentially life-threatening consequences. Among the dangers with unregulated or illegal pharmaceutical sales are: 1) counterfeit products that do not contain the ingredients named; 2) diluted products or outdated products, perhaps relabeled with a false expiration date; 3) financial scams in which no product is delivered, or credit card numbers are stolen or misused; and 4) tainted products that could actually harm people who take them. These practices may not be predominant, but it is difficult for individuals to evaluate web and e-mail offers that are "too good to be true." The FDA has established consumer advice regarding such purchases, which is available on its web site at http://www.fda.gov/ . ⁽⁴⁾

In Florida and Washington, the state attorneys general filed suit in early January 2002 to close down an online pharmacy and a Florida doctor who prescribed Cipro "without examining patients or speaking to them" according to the New York Times. ⁽⁷⁾

In May, 2007 the National Center on Addiction and Substance Abuse identified 581 Web sites that offer controlled prescription drugs, compared with 492 in 2004. Both the center and the DEA say it's impossible to know exactly how many such sites there are, with estimates ranging from a few hundred to more than 1,400.  "These Web sites come and go very quickly," said Susan Foster, vice president of policy research and analysis at the center. "They could be up one day and operating under a different URL the next day."  Most of the sites identified by the center were so-called portal sites, which don't directly sell drugs. They lead browsers to anchor sites, where the drugs are sold.  The study identified 187 anchor sites. Of those, 157 did not require a prescription. (10) 
 "'You've Got Drugs!' IV: Prescription Drug Pushers on the Internet"  (2007) | You've Got Drugs.. Internet (2006) - National Center on Addiction and Substance Abuse, Columbia Univ., 5/07
 More Rx Drug Sites Operating; Many Violate Law, Study Finds - ABC News, August 23, 2007

State regulatory and informal safeguards within U.S.: Not all Internet sales include a risk of fraud or inappropriate use. In the past two years the National Association of Boards of Pharmacy, which represents almost all the state regulatory boards that certify and oversee retail pharmacies and pharmacists, has launched a program called Verified Internet Pharmacy Practice Sites®. Their release states, "NABP Urges Consumers to Look for the VIPPS Seal before Buying Antibiotics and Other Drugs Online." ⁽²⁾

All pharmacies shipping drugs to West Virginia and Kentucky have to be registered with those states' Board of Pharmacy.  Some rogue pharmacies carry disclaimers saying they won't ship to those states.  Since the passage of a 2005 law banning the importation of drugs from unlicensed online pharmacies, the Kentucky Bureau of Investigation has seized more than $1.5 million worth of controlled pharmaceuticals, according to an AP story in August 2007.  Other states recently passing laws to address online pharmacies include Arkansas (2007), Idaho (2006), Iowa (2005), Louisiana (2007), Nevada (2003), Texas (2007) and Wisconsin (2006).

British Online Pharmacy Certification.  The Royal Pharmaceutical Society of Great Britain in January 2008 launched a new logo which will be seen on the front page of participating online pharmacy sites. It is hoped that this will help people identify whether a website offering to sell medicines or provide other pharmacy services is connected to a registered pharmacy. By clicking on the logo visitors are linked to a page on this website where they can make checks to ensure the site is a registered pharmacy. The prpgram has a descriptive web site, effective January 2008.

"States Take Action on E-Rx, But Federal Role Remains Unclear"                   September 4, 2007                                                                                                 by Kate Ackerman, iHealthBeat Associate Editor   (c) iHealthbeat - all rights reserved Despite proven benefits and broad support for electronic prescribing, legal and bureaucratic red tape have hampered adoption of the technology. That is beginning to change: Alaska last month became the final state to change laws and regulations to allow for e-prescribing. Timothy Brogan -- senior director of research and policy at the Pharmaceutical Care Management Association, a national association of pharmacy benefit managers -- said although there is nearly universal support for e-prescribing, "the issue has been really more about getting it done." He noted that while e-prescribing often gets tied up with larger health IT issues, it is actually a fully developed and implemented technology.  "It really is the on ramp to the information superhighway for physicians, and it's a good first step to electronic medical records," Brogan said.   State Progress: Slow and Steady SureScripts -- founded by the National Association of Chain Drug Stores and the National Community Pharmacists Association to boost the quality, safety and efficiency of the medication administration process -- in early 2002 began meeting with state legislators and pharmacy boards to begin the process of ensuring that e-prescribing was legal.  When the Pharmacy Health Information Exchange, operated by SureScripts, was launched into full production in early 2004, half of the states had laws and regulations that would have prohibited the electronic exchange of prescription information because, in essence, the network could be considered a third party. "We definitely did not anticipate that it would have taken the number of years that it has since we started doing this," Kevin Hutchinson, president and CEO of SureScripts, said. He added, "The interesting thing is that we never found a single state or a single pharmacy board who was anti-e-prescribing." Instead, it was "the normal political process of some of the markets and some of the states that did in fact slow down getting this done through all markets," he said. Kevin Nicholson, vice president of pharmacy regulatory affairs at NACDS, said his organization did not have expectations about how long it would take to change state regulations to allow for e-prescribing. He said, "We recognize that change does come slowly in the legislative and regulatory areas." Now, with all 50 states and Washington, D.C., connected to SureScripts' Pharmacy Health Information Exchange and more than 95% of the nation's retail pharmacies using certified e-prescribing software, a surge in e-prescribing adoption and use seems imminent. However, neither state nor federal law requires the use of e-prescribing.   States Move at Different Paces While every state now allows for e-prescribing, some states have gone above and beyond.  The eRx Collaborative, a payer-supported e-prescribing initiative in Massachusetts, has provided about 4,800 physicians with PDAs and software. The initiative last month announced that over the past three and a half years, its members have transmitted more than 10.8 million e-prescriptions.  Meanwhile, Minnesota last month announced plans to require doctors to use e-prescriptions by 2011 to participate in the state health plan for public employees and their families. Minnesota also will require pharmacies to obtain the equipment necessary to accept e-prescriptions by 2009.   Role of the Federal Government Despite progress on the state level, it remains unclear what kind of role the federal government should take in driving adoption. The federal government has been active in defining standards for e-prescribing, according to Hutchinson. The Medicare Modernization Act of 2003 was the "launching pad of what established [the National Council for Prescription Drug Programs] Script standard for e-prescribing," he said.

Emergency preparedness and pharmaceuticals

In times of emergency, state governments help ensure the public's safety. For example, in 2000, Colorado enacted HB 1077 amending its Disaster Emergency Act, related to state preparedness for bioterrorism attacks (and other public health threats). The new legislation established an Emergency Epidemic Response Committee to devise a plan to allocate medical resources in times of emergency. The law includes a provision for "procuring or taking" supplies of medication for use in an emergency. Denver was one of three cities across the country that simulated an attack with a weapon of mass destruction in May 2000, under a congressionally mandated test of emergency preparedness called "Operation TOPOFF." Denver's case was a simulated bioterrorism attack, which along with other state planning activities helped stimulate the legislation. The law is highlighted in an Oct. 27, 2001 Rocky Mountain News article.

2002-03 draft state act:  In response to the recent anthrax attacks and increased concerns about biological emergencies, a group convened under sponsorship of CDC (including Larry Gostin and James Hodge of the Public Health Law Center at Johns Hopkins/Georgetown Universities) created a draft Model State Emergency Powers Act for states to use as appropriate. The 40-page draft is detailed in terms of the proposed powers for state agencies to handle either an epidemic or a bioterror attack. For pharmacists, the draft act proposes the following:

The latest model act publication, dated June 2002, is available online in PDF format. A related state initiative was the Public Health Statute Modernization Collaborative.

2001-2008 state laws on emergency pharmaceutical policies:

NCSL published a manual "Protecting Democracy: America's Legislatures Respond" in 2002. Health issues are covered in Chapter 5 [32 pages, available for download ]. The following are examples of new laws from 16 states specific to pharmaceuticals in emergencies, primarily aimed at faster and broader access to drugs, but not related to pricing.   NOTE: This list does not include laws authorizing "student cccess to self-administer asthma or anaphylaxis medications in indivudual emergency cases.
(links lead to text of the laws): ¹⁰

• Arizona H 2155 of 2007 - Authorizes continuation of prescriptions during a declared period of emergency or terrorist attack including pharmaceutical care and drug and device delivery, use of a temporary or mobile pharmacy facility and nonresident licensed pharmacy professionals; may apply to a disaster or attack in another state; authorizes a one-time emergency refill prescription.  Signed as Chapter 207 on 05/14/07.  
• Colorado HB 1077 of 2000 - Includes a provision for "procuring or taking" supplies of medication for use in an emergency.
  Colorado S 229 of 2007 - Creates a legislative emergency epidemic response committee to develop a response plan in the event of an emergency epidemic; provides that the Department of Public Health and Environment may enter into partnerships to purchase antiviral therapy in order to acquire a ready supply or stockpile of antiviral drugs in the event of an epidemic emergency. Signed 5/25/07 as Chapter 301. H 377 of 2002 - "Delaware Emergency Health Powers Act" Includes duties of Health Care Providers to Report Medical Conditions, and reports of Prescription-Related Events. Authority to Control Pharmaceutical Agents and Medical Supplies. Enacted 7/3/02.
• Connectcut S 1192 of 2007 - Provides that emergency Potassium Iodide tablets must be available and stocked at  child day care services, youth camps to be provided in nuclear-related emergency situations.  Signed 6/29/07 as Chapter 129 of 2007. 
• Delaware
• Florida S 1262 of 2002 - Grants the State Health Officer the authority to direct Pharmaceutical Agent Distribution. Enacted 5/23/02.
• Indiana SB 180 of 2001 - Requires the state Emergency Medical Services Commission to conduct training on and establish certification standards for the administration of antidotes, vaccines and antibiotics in situations related to a terrorist or military attack. Enacted 4/01.
  Indiana SB 202 of 2006 - Allows for suspension of restrictions on operations and locations of pharmacy distribution in the event of a state of emergency declared by the Governor or the President of the U.S.
  Indiana H 1468 of 2007 - provides for pharmacist distribution and immunizations in an emergency declared by Homeland Security.  
• Maryland H 303 of 2002 - Provides the authority to adopt rules and regulations necessary to prevent the introduction and spread of infectious or contagious disease in the state. Enacted 4/9/02. Public Health Emergency Preparation and Response Act includes the Authority to Control Pharmaceutical Agents. Enacted 5/17/02.
• Missouri H 579 of 2007 - Allows the recruitment, training and the acceptance of services of citizen volunteers to dispense medication in a public health emergency.  Signed 6/8/07. 
• New Hampshire H 1478 of 2002 -
• New Jersey SB 2140 of 2003- Provides immunity to public entities and public employees for acquiring, stockpiling, distributing and dispensing drugs and vaccines which mitigate effects of exposure to nuclear, chemical, and biological agents. Signed as Public Law 2003, Chapter 155, 4/23/03.
• New York S 4021 of 2007 - Pandemic Flu Preparedness and Reporting act authorizes to dispense or distribute antibiotics, anti-viral medications or other pharmaceuticals as part of the approved public health program.  Signed 7/8/07 as Chapter 317. 
• North Carolina H 748 of 2007 -  Requires all health care insurers and the public employees' Medical Plan to allow filling of extra prescriptions during a state of emergency or disaster. Signed 6/27/07 as Chapter 2007-133. H 4416 of 2002 - Provides power to control pharmaceutical agents and medical supplies. Enacted 7/2/02.
• South Carolina
• South Dakota H.1303 of 2002- Revises the authority of the Governor to handle, in event of a disaster, war or act of terrorism. Adds control of pharmaceuticals and medical supplies. Enacted 2/27/02. H 2183 of 2003 - Authorizes "persons who are not authorized by law to administer or dispense drugs or devices to administer or dispense all necessary drugs or devices in accordance with protocols established by the Commissioner when: (i) the Governor has declared a disaster or a state of emergency caused by an act of terrorism or the United States Secretary of Health and Human Services has issued a declaration of an actual or potential bioterrorism incident or other actual or potential public health emergency; (ii) it is necessary to permit the provision of needed drugs or devices; and (iii) such persons have received the training necessary to safely administer or dispense the needed drugs or devices. Signed 3/20/03 as Chapter 794 of 2003.
  Virginia H 2845 & S 1108 of 2007 - Relates to emergency preparedness and authorizing the dispensing of necessary drugs and devices by designated emergency personnel. Signed 3/21/07 as Chapter 699 and Chapter 783.
• Virginia
• Washington H 1098 of 2007 - Authorizes suspension of restriction on the availability of vaccines during an outbreak of a vaccine-preventable disease or of a shortage of vaccine; includes a mercury-content notification requirement.  Signed 5/2/07 as Chapter No. 2007-268.

APPENDIX A - Federal Agency Advice and Resources

APPENDIX B - More News and Opinions

Related NCSL Reports:

State Initiatives to Avoid Prescription Drug Errors - Several laws enacted and bills considered anticipate problems and use state powers to provide some solutions, 2003-2006 - NCSL report. updated 12/06.
RFID CASE STUDIES - NCSL FALL FORUM - 12/05

Sources and Opinions

• - Prescription Drugs: Importation for Personal Use - Congressional Research Service, Library of Congress, August 24, 2001
• - NABP Urges Consumers to Look for the VIPPS Seal before Buying Antibiotics and Other Drugs Online - National Association of Boards of Pharmacy, 2003 update.
• - Buying Medicines and Medical Products Online - U.S. Food and Drug Administration website at http://www.fda.gov/oc/buyonline/default.htm. The FDA states: "Don't purchase from foreign Websites at this time because generally it will be illegal to import the drugs bought from these sites, the risks are greater, and there is very little the U.S. government can do if you get ripped off."  (updated 1/06)
• - New CDC Fact Sheets: for the latest update on CDC activities and on-going bioterrorism and disease investigations visit www.bt.cdc.gov. Updated regularly, 2006.
• - Frank R. Lichtenberg, "Cipro and the Risks of Violating Pharmaceutical Patents," Brief Analysis No. 380, November 15, 2001, National Center for Policy Analysis.
• "Were Reports of Cipro Hoarding All Hype?" Drug Topics, October 15, 2001
• "U.S. Changes Its Stance on Radiation Exposure Regimen, New York Times, December 11, 2001.
  One private web source "Potassium Iodide Anti-Radiation Pill FAQ" states, "There are only three U.S. non-prescription, over-the-counter Potassium Iodide (KI) tablets available: (Iosat, Thyro-Block, Rad Block), and one Potassium Iodate tablet source (Medical Corps®) along with a handful of retailers carrying some of these products. (Anyone can purchase the active ingredient in KI tablets, USP grade Potassium Iodide)."
• The U.S. Nuclear Regulatory Commission (NRC) is giving states the option of stocking up on potassium iodide for communities near the nation's 103 nuclear power plants. However, the NRC also emphasizes that the drug has a limited function, "It can protect only one part of the body against only one radioactive element." Quoted in Time, December 17, 2001
• "Anti-Anthrax Drug Sold Online Leads to Suit: Lack of Prescriptions and Contact is Cited" - New York Times, January 12, 2002. 
• "No Prescription? No Problem Online" - Associated Press as reported in Washington Post, 8/23/07. 

Compiled by Richard Cauchi, NCSL Health Program, Denver, Colorado. Initial report posted 10/17/01 with updates as needed. This report is a general review of laws and policies; it is not intended as medical or legal advice.