Laws and regulations
Federal requirements for handling and disposal of pharmaceutical substances and waste
The Resource Conservation and Recovery Act (RCRA), enacted in 1976, is the primary federal law in the U.S. that governs solid and hazardous waste. It covers the full waste lifecycle, including generating, transporting, treating, storing, and disposing of hazardous waste. RCRA also established a framework for managing non-hazardous solid waste.
Hazardous waste is any substance that is determined to be hazardous by the EPA, CDC, or FDA, or that has hazardous properties such as:
- Corrosiveness
- Flammability
- Releasing toxic gases
- Carcinogenicity
- Reproductive harm
- Poisoning/toxicity
Examples include acids, alcohol, antineoplastic drugs, warfarin, and benzene.
Hazardous pharmaceutical waste should never be flushed down a toilet or poured into a drain because it can contaminate the environment. Facilities typically collect waste in color-coded bins for disposal. You’ll also want to use appropriate personal protective equipment (PPE) when handling or disposing of any pharmaceutical waste.
Table showing color coding for waste disposal
| Color coding | Use |
|---|---|
| Red | Disposal of blood and blood products, body fluids, sharps, PPE that has come into contact with blood, body fluids, or infectious material |
| Yellow | Disposal of chemotherapy waste, including tubes, IV bags, and sharps used for chemotherapy |
| Blue and white | Any pills, injectables, and antibiotics (only non-hazardous waste) |
| Black | Hazardous pharmaceuticals, radioactive waste |
Hazardous drugs must be prepared using appropriate PPE and engineering controls. Exposure can occur through inhalation or direct skin contact during common tasks such as transferring, reconstituting, or mixing drugs; labeling; and setting up IV lines.
Sharps (such as needles) must be disposed of in clearly marked, leak-proof, puncture-resistant containers. Hazardous drugs should also be:
- Stored separately from non-hazardous drugs
- Clearly labeled as hazardous
- Kept in an area with limited access
The Occupational Safety and Health Administration (OSHA) helps ensure safe and healthful working conditions by setting and enforcing standards. OSHA was created in 1970 under the Occupational Safety and Health Act.
Federal requirements for controlled substance prescriptions
The Controlled Substances Act (CSA) places regulated substances into one of five schedules (Schedules I-V). Scheduling is based on:
- Accepted medical use
- Potential for abuse
- Safety and risk of dependence
You can review the schedules in the DEA Drug Schedules Section.
Some important things to consider involving the processing and dispensing of controlled substances in the pharmacy are as follows:
- All prescribers need a DEA number to write a prescription for controlled substances. Under federal law, a prescription for a controlled substance may only be issued by a physician, dentist, veterinarian, or mid-level practitioner.
- Verbal orders cannot be made for Schedule II medications except in an emergency situation. The prescription should be checked for completeness and accuracy.
- Schedule II medications cannot be refilled. Instead, they need a new prescription for every fill.
- Schedule III and IV cannot be refilled after six months or five times, whichever is earlier.
- Schedule V medications may be written for up to 1 year, although many states limit this to 6 months.
- Government-issued photo IDs are required to pick up controlled prescriptions.
- Transfer of Schedules I and II requires filing DEA Form 222 and must be to an authorized DEA registrant.
- Transfers for Schedules III through V drugs are limited; only one transfer is allowed per day unless the two pharmacies share a real-time database. Any remaining refills must be processed at the pharmacy to which they were transferred.
- In the event of a significant loss of controlled substances, pharmacies must notify the DEA in writing through Form 106 within a business day.
Controlled substance prescribing, partial fills, and DEA compliance
Although refills are not permitted for Schedule II drugs, prescribers may issue three separate prescriptions, each for a 30-day supply. These prescriptions include a “do not fill until” date. The pharmacist cannot legally fill the prescription before that date.
For example, if the “do not fill until” date is 10/15/2025, the earliest date the prescription may be filled is 10/15/2025. A common approach is to space sequential prescriptions 30 days apart.
Partial fills for controlled substances: Federal regulations allow partial fills when the pharmacy does not have enough stock. In that situation, the remaining quantity must be dispensed within 72 hours of the partial fill; otherwise, a new prescription is required.
If a prescriber or patient requests a partial fill, the remaining quantity can be completed within 30 days (except for emergency prescriptions). These partial fills must be properly documented. If state law is more stringent, state law should be followed.
Partial fills for Schedules III-V drugs are permitted up to 6 months from the date the prescription was issued. The total dispensed quantity must not exceed the total prescribed quantity.
Transferring prescriptions for Schedule II controlled substances between pharmacies: An electronic prescription for a Schedule II substance may be transferred once to another pharmacy for the purpose of initial fill only, upon patient request, along with any authorized refills included with the original prescription.
Transferring prescriptions for Schedules III-V controlled substances between pharmacies: Transferring a prescription for a controlled substance between Schedules III-V between pharmacies is allowed only once. If the pharmacies share a real-time, online database, then they can transfer up to the maximum refills on the prescription. The transfer must be communicated directly between the two licensed pharmacists. The invalidated prescription is marked “VOID”.
Record-keeping of controlled substances: Records for controlled substances, whether paper or electronic, must be maintained for a minimum of two years. Schedule II records should be kept separately from Schedules III through V.
Inventory requirements for controlled substances: Inventory is taken at pre-determined intervals, as follows:
- Initial inventory - A complete and accurate record of any controlled substance should be taken on the first date that the pharmacy dispenses the controlled substance.
- Biennial inventory - A new inventory for all stocks of controlled substances on hand should be taken at least every two years.
Table showing important DEA forms for use in a pharmacy
| DEA form number | Use |
|---|---|
| 222 | Purchase or transfer of Schedule I and II controlled substances |
| 224 | To apply for a new DEA registration or renewal |
| 41 | Disposal of controlled substances |
| 106 | To report theft or significant loss of controlled substances |
| 104 | Voluntary surrender of controlled substance privileges by DEA registrants |
| 223 | Certificate of registration issued by the DEA |
The Comprehensive Addiction and Recovery Act (CARA): The CARA Act was passed in 2016 to address the opioid crisis by funding prevention, treatment, and recovery efforts; supporting naloxone training; promoting prescription drug monitoring programs; and supporting patients and families. CARA permits pharmacists to partially fill prescriptions for Schedule II medications. It also supports pharmacist involvement in naloxone access to treat opioid overdose. CARA expanded options for safe medication disposal by supporting drug take-back programs.
Federal requirements for receiving and storing controlled substances
Each commercial container of a controlled substance must display a clear symbol on the label that identifies the schedule in which the substance is listed. Controlled substances must be stored securely in a steel safe or vault, with access limited to authorized individuals.
Federal requirements for restricted drug programs
Some medications can cause serious adverse effects in certain populations or under specific conditions. For example, isotretinoin (used for acne) can cause severe birth defects in a developing fetus. Federal programs such as REMS and the Combat Methamphetamine Epidemic Act were created to reduce these risks and protect vulnerable populations.
The Combat Methamphetamine Epidemic Act (CMEA), passed in 2005, established retail sales limits (in grams) for scheduled listed chemical products, including pseudoephedrine. Ephedrine, pseudoephedrine, and phenylpropanolamine are precursor chemicals used in the illicit manufacture of methamphetamine or amphetamine and are common ingredients in cold and allergy products.
Under the CMEA:
- The daily limit is 3.6 grams per purchaser.
- The 30-day limit is 9 grams per purchaser.
Pseudoephedrine (common brand name Sudafed) must be kept behind the counter or in a locked cabinet and cannot be sold without photo identification. The buyer’s name, address, signature, date, and time of sale must be recorded, and a logbook of pseudoephedrine sales must be maintained.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) amended the CSA to help prevent illegal distribution and dispensing of controlled substances over the Internet. It requires that a practitioner conduct at least one in-person medical evaluation of the patient before prescribing a controlled substance via the Internet.
The Risk Evaluation and Mitigation Strategy (REMS) is an FDA drug safety program for medications with serious safety concerns. The goal is to ensure the medication’s benefits outweigh its risks. Common medications with REMS programs include isotretinoin, clozapine, and thalidomide.
Under REMS, prescribers, pharmacists, and patients must meet specific requirements to access the medication. These requirements may include training, documenting safe-use conditions (such as negative pregnancy tests), obtaining recent liver function test results, or enrolling in patient registries.
FDA recall requirements
A recall is a voluntary method of removing or correcting products that violate FDA laws. Recalls may be initiated for reasons such as safety concerns, contamination, or mislabeling.
Recalls are classified as follows:
Class I: Recalls for products that could cause severe injury or death
Class II: Recalls for products that might cause significant injury or temporary illness
Class III: Recalls for products that are unlikely to cause injury or illness but violate FDA regulations
The FDA reports recalled products in its weekly enforcement report. The FDA works with the manufacturer to develop a recall strategy so recalled products are safely destroyed and corrective actions are taken to prevent future safety issues. In 2023, over-the-counter eye drops sold in many retail pharmacies were recalled due to microbial contamination.