Hazardous Handling, Returns and Disposal

Introduction

Before you handle, return or throw away any medicine, answer three separate questions.

1. Could touching it harm the worker? This is a worker-safety question.
2. What waste rules apply when it is thrown away? This is an environmental question.
3. Must every unit be accounted for? This is a controlled-substance question.

Then ask a fourth question: whose medicine is it? The pharmacy's own stock follows different disposal routes from a patient's leftover medicine.

Each answer leads to a different procedure. A product can be a "yes" for one question and a "no" for another. Most disposal mistakes happen when someone answers one question and assumes it settles the others.

What you will be able to do

• Tell apart a hazardous drug, a hazardous waste and a controlled substance, and explain why one label does not imply another.
• Separate disposal of the pharmacy's own inventory from household take-back of patients' medicines.
• Choose an authorized disposal pathway for controlled pharmacy stock and name what authorizes it.
• Recognize who may use an authorized collection receptacle, what may go in it, and how access to it is controlled.
• Recognize when a spill or a sharp needs a specialized response, including the first steps after an accidental injury from a used sharp.

Before you start

You only need everyday reading. This lesson defines each new term before relying on it.

It helps to know that controlled substances are sorted into schedules I through V. That topic is covered in Controlled-substance schedules and valid orders. Routine returns of non-controlled stock are covered in Return to stock, expired stock and reverse distribution.

This lesson describes federal US rules. State, tribal and local laws can add requirements or differ, so following a federal rule does not by itself show you have met every rule. Your pharmacy's written procedures and your pharmacist decide how each rule is carried out where you work. Your job as a technician is to recognize the situation correctly and route it to the right procedure.

Three labels that answer three different questions

Hazardous drug: a risk to the people handling it

Plain meaning: a hazardous drug is a medicine that can harm the workers who touch it or breathe it, not only the patient it is meant for.

The National Institute for Occupational Safety and Health (NIOSH) publishes a list of drugs it considers hazardous in healthcare settings. Examples of the kinds of drugs involved include some cancer therapies, antivirals, hormone therapies and bioengineered agents. Workplace exposure has been linked to:

• skin rashes
• reproductive harm
• possibly leukemia and other cancers

The risk to a worker depends on two things: how much exposure the worker has, and how toxic the drug is. That is why exposure matters at every step, not only during preparation. NIOSH names pharmacy staff as at-risk workers. It also names shipping and receiving personnel, so opening a delivery tote can be an exposure point.

NIOSH updates its list. Drugs have been both added and removed. For example, liraglutide and pertuzumab were removed in published final determinations. Check your facility's current list instead of relying on memory.

Hazardous waste: a risk to the environment once discarded

Plain meaning: hazardous waste is a federal category for discarded material that needs special waste handling instead of the trash or the drain.

Under the Resource Conservation and Recovery Act (RCRA), enforced by the Environmental Protection Agency (EPA), a discarded medicine is hazardous waste in either of two ways.

• Listed waste: its chemical appears on EPA's P- or U-lists. About 30 chemicals with pharmaceutical uses are listed. For example, cyclophosphamide, a chemotherapy ingredient, is listed hazardous waste code U058. A P- or U-listing does not cover every discarded product that happens to contain a named chemical. It applies to an unused commercial chemical product: the pure or technical grade of the chemical, or a formulation in which the listed chemical is the sole active ingredient, when the listing's other conditions are met. A product with more than one active ingredient falls outside the listing, even if one of those ingredients is listed. So an unused cyclophosphamide product may carry U058 when discarded if cyclophosphamide is its sole active ingredient and the listing conditions hold.
• Characteristic waste: the discarded product shows one of four properties: ignitability, corrosivity, reactivity or toxicity. For a liquid, alcohol percentage alone does not decide ignitability. Under EPA's test, a liquid is ignitable if its flash point, the lowest temperature at which its vapor can catch fire, is below 60°C (140°F). Water-based (aqueous) solutions containing less than 24 percent alcohol by volume are excluded. You cannot tell from the label's alcohol percentage alone whether a liquid is ignitable; that depends on the exact formulation and the facility's waste determination.

Since 2019, EPA has banned healthcare facilities and reverse distributors from putting hazardous waste pharmaceuticals down a drain or toilet. Retail, mail-order and long-term care pharmacies count as healthcare facilities for this rule. The ban applies in every state. EPA also strongly discourages flushing any medicine, with very few exceptions.

Legally, the facility decides which of its medicines count as hazardous waste. A facility may also simply follow EPA's recommendation not to flush any medicine at all. As a technician, you follow the pharmacy's waste program. You do not make that legal decision on your own.

Controlled substance: a diversion risk that requires accountability

Plain meaning: a controlled substance is a medicine whose every unit must be tracked, so it does not end up misused or sold illegally ("diverted").

Under the Controlled Substances Act, controlled substances move in a "closed system." Everyone who legitimately handles them, including pharmacies, must be registered with the Drug Enforcement Administration (DEA), unless exempt, and must keep strict records. A pharmacy holding a DEA registration is called a registrant.

Worked example: one product, three separate checks

A tote arrives holding expired oral solution. Suppose the facts are these:

• The product is a schedule II controlled substance.
• Its label states 30 percent alcohol.
• Your facility's waste determination has confirmed that this formulation is ignitable hazardous waste.
• It is not on your facility's hazardous drug list.

Run each check separately.

• Worker hazard: Not being on the facility's hazardous drug list is not an automatic clearance. It does not by itself show that no handling precautions are needed. Consult the current hazard information for this product and follow your facility's assessment and procedure for handling it.
• Hazardous waste: The 30 percent alcohol on the label does not settle this by itself. The facility's determination has confirmed this formulation is ignitable hazardous waste, so it must never go down a drain.
• Controlled: It is schedule II. Disposal must follow a DEA-authorized pathway with records.

Notice that "not on the hazardous drug list" did not mean "safe to pour out." Also notice that "controlled" did not tell you anything about ignitability. EPA states plainly that the sewer ban applies to controlled substances that are also hazardous waste.

Change one fact: a tablet product contains the same active ingredient. A tablet is not a liquid, so the liquid flash-point test does not apply to it. The tablet may not be ignitable even though the liquid is.

The tempting mistake is to think the same ingredient means the same waste status. Waste characteristics can depend on the formulation, meaning what the product is actually made of, and the facility makes the waste determination for each product. The tablet is still controlled, though, because controlled status follows the substance.

Question 1

A technician says, "This drug is on the NIOSH hazardous drug list, so it is definitely a controlled substance and must be logged with DEA." What is wrong with this reasoning?

Question 2

A pharmacy discards a listed hazardous waste chemical that is not controlled. A coworker says it can go down the sink because "only controlled drugs have special disposal rules." Is that right?

Whose medicine is it? Pharmacy inventory versus household take-back

Pharmacy stock and patient medicine take different routes

Plain meaning: the pharmacy's own stock and a patient's medicine are disposed of through different, non-interchangeable routes.

The key term is ultimate user: a person who lawfully obtained a controlled substance and possesses it for their own use, for a member of their household, or for an animal owned by them or a household member. In plain terms, this is the patient or the household the medicine was dispensed for.

• Pharmacy inventory is stock the pharmacy owns: expired bottles, recalled lots, overstock. The pharmacy is a DEA registrant. Its controlled inventory must leave through registrant disposal routes, covered in the next section. DEA states that a registrant's controlled inventory may not be disposed of through drug take-back collection.
• Household medicine belongs to the ultimate user. Take-back means a patient hands in unwanted medicine for destruction, through a collection receptacle or a mail-back envelope. EPA and the Food and Drug Administration (FDA) both say the first choice for households is a take-back location or mail-back envelope.

Where the FDA Flush List fits

FDA keeps a short "Flush List" of medicines that can be deadly in small doses. It recommends flushing them only in households, and only when take-back is not readily available. The list is not guidance for pharmacies or any other facility. Healthcare facilities must follow EPA's sewer ban even for Flush-List items.

Worked example: same drug, different owner

The pharmacy has an expired bottle of a schedule IV tablet in stock. At the same time, a patient brings in their own leftover bottle of the same tablet.

• The pharmacy's bottle is registrant inventory. It goes through a registrant pathway, such as a reverse distributor.
• The patient's bottle belongs to an ultimate user. If the pharmacy is an authorized collector, the patient may put it in the collection receptacle themselves.

The drug is identical. The owner decides the route. Putting the pharmacy's expired stock into its own collection receptacle would mix a registrant's inventory into a channel built only for ultimate users.

Changed case: the medicine is abandoned

A patient leaves a bag containing a controlled medicine on the counter and leaves. It is no longer in the patient's possession, so nobody eligible is depositing it.

DEA guidance for this situation:

• Try to contact the person.
• If you reach them, the medicine may be returned to the owner in person after confirming they are the ultimate user.
• If return is not possible, DEA regulations do not let the practitioner dispose of it. Contact state, local or tribal law enforcement, or the local DEA office, for guidance.

Some states let certain hospitals and similar institutions dispose of abandoned patient medicines. DEA's definition of an institutional practitioner excludes pharmacies, so that exception does not describe retail pharmacy stock.

DEA also warns that abandoned pills may be counterfeits containing fentanyl or other dangerous substances. Handle them with extreme care.

Question 3

A pharmacy is closing out expired controlled stock. A coworker suggests emptying it into the store's take-back kiosk because "it all gets destroyed anyway." What is the problem?

Question 4

A pharmacy's waste vendor is delayed. A coworker points out that one expired product is on FDA's Flush List and suggests flushing it. What should you recognize?

Controlled pharmacy stock: four authorized pathways

Plain meaning: when a pharmacy gets rid of its own controlled stock, federal rules allow only a few routes. Each route has its own authorization and paperwork.

Whatever the route, destruction must make the substance non-retrievable. That means it is permanently unusable and cannot be turned back into a controlled substance. Destruction must also follow federal, state, tribal and local law.

The four routes for a pharmacy's controlled inventory are:

1. On-site destruction. The pharmacy promptly destroys the substance at its registered location using a method that actually achieves the non-retrievable result. The destruction is documented on DEA Form 41. DEA does not approve disposal products. A product's label claiming it meets the standard is not enough; the method must actually achieve the result.
2. Reverse distributor. A reverse distributor is a DEA-registered company that takes controlled substances for destruction. The pharmacy promptly delivers the stock to the reverse distributor's registered location, by common or contract carrier pick-up, or the reverse distributor picks it up at the pharmacy. For schedule II substances, the reverse distributor issues the pharmacy a DEA Form 222 or its electronic equivalent. Form 222 is the official record for schedule II transfers.
3. Return or recall. The pharmacy promptly delivers the stock to the registered supplier it came from, the registered manufacturer, or another registrant the manufacturer authorized to accept returns or recalls. Delivery is by carrier pick-up or pick-up by those registrants at the pharmacy.
4. Special Agent in Charge assistance. The pharmacy submits a DEA Form 41 listing the substances to DEA's Special Agent in Charge for its area. The agent then directs one of three outcomes: transfer to an authorized registrant, delivery to DEA, or destruction witnessed by an authorized person.

Never send drugs to DEA unless DEA has approved it in advance.

Worked example: expired schedule II stock

A pharmacy has expired schedule II tablets and uses a reverse distributor.

1. The route is option 2.
2. Pick-up happens by carrier or by the reverse distributor at the pharmacy.
3. Because the drug is schedule II, the reverse distributor issues the Form 222 to the pharmacy.

A common mix-up is thinking the pharmacy issues the form because the pharmacy is sending the drug. In this transfer, the receiving reverse distributor issues it.

Change one fact: the manufacturer recalls the lot instead. Now return or recall to the supplier, the manufacturer, or the manufacturer's authorized registrant fits the purpose. For tracing returns through these channels, see Trace pharmacy inventory through authorized return channels and Recalls, tracing and suspect products.

Change a different fact: the pharmacy destroys the stock on-site. Now the key checks are a truly non-retrievable method, compliance with state and local law, and a DEA Form 41 record.

Question 5

A pharmacy buys a chemical pouch whose packaging says "Meets DEA non-retrievable standard." Does using it automatically make on-site destruction compliant?

Question 6

A new technician plans to box up outdated controlled stock and mail it to the nearest DEA office, because "DEA handles controlled substances." What should happen instead?

The collection receptacle: who, what, and how access is controlled

Plain meaning: a collection receptacle is a locked drop box where patients themselves deposit their own unwanted medicines. Once something goes in, nobody sorts or counts it.

Who may host one

Not every pharmacy may host a receptacle. A retail pharmacy, or a hospital or clinic with an on-site pharmacy, must first modify its DEA registration to become an authorized collector. There is no fee, and the authorization is subject to renewal. Law enforcement agencies may also run collection receptacles.

Who may deposit, and what

Only these people may deposit:

• an ultimate user in lawful possession of the medicine
• a person lawfully entitled to dispose of a deceased ultimate user's property
• a long-term care facility acting for a current or former resident, using a receptacle at that facility under specific rules

Only these items are accepted:

• controlled substances in schedules II through V that the depositor lawfully possesses
• non-controlled medicines, but only if the collector chooses to accept both together

These are not accepted:

• schedule I substances
• controlled substances the person does not lawfully possess
• other illegal or dangerous substances

A sign on the receptacle must say what is and is not accepted.

The pharmacy must not let a patient hand the medicine to anyone, staff included, for any reason. The patient puts it in themselves. After deposit, the contents must not be counted, sorted, inventoried or individually handled.

How access is controlled

Placement. At a pharmacy, the receptacle sits inside the registered location, close to where controlled substances are stored, where an employee is present. For example, it should be visible from the pharmacy counter. At a hospital or clinic, it must be in an area employees regularly monitor and not near emergency or urgent care areas.

Design. - It is fastened to a permanent structure so it cannot be removed. - It is locked and sturdy, with a permanent outer container and a removable inner liner. - Its small opening lets items in but does not let contents be taken out.

When no employee is present. The opening must be locked or otherwise blocked whenever no employee is present, such as when the pharmacy is closed.

Liner changes. At least two of the collector's employees must install and remove the inner liner, or supervise it. The removed liner is sealed and is not reopened. It is then promptly destroyed or securely stored until destruction, through an authorized route.

Worked example: a patient at the kiosk

A patient brings their own leftover schedule II tablets to an authorized pharmacy's receptacle during open hours. They are an ultimate user, the substance is schedule II, and they lawfully possess it.

They deposit it themselves. No one records the bottle's count.

Change one fact: the patient asks the technician to "just drop it in for me." The rule forbids the patient transferring it to anyone. The technician should direct the patient to deposit it personally.

Change another fact: it is after closing. The opening must already be locked or inaccessible, so the patient comes back during open hours or uses another take-back option.

Question 7

A patient wants to deposit a used insulin pen needle in the drug receptacle. What should you recognize?

Question 8

During a liner change, a technician notices a bottle near the top and wants to count its tablets "for the records." What is wrong with that?

Spills and sharps: when routine cleanup is not enough

Hazardous drug spills

Plain meaning: a hazardous drug spill is a worker-exposure event. It needs the facility's prepared spill response, not improvised cleanup.

NIOSH recommends protecting workers using the hierarchy of controls, a ranked order of protections from most to least effective:

1. Remove the hazard or substitute something safer, where feasible.
2. Use engineering controls: barriers or ventilation that contain the drug.
3. Use administrative controls: work practices and procedures.
4. Use personal protective equipment (PPE), such as gloves and gowns.

PPE is the least effective layer. It is still necessary when the other layers are not in place or not fully protective. Facilities choose PPE based on an assessment of the specific hazards.

For spills, NIOSH says facilities should prepare in advance:

• written procedures (SOPs) that assign who does what, such as who reports the spill and who cleans it up
• spill kits that are readily available
• trained workers and practice drills
• a plan, made with the waste company, for what happens to used wipes and PPE, since these may themselves be hazardous waste

Where corrosive drugs are handled, there should be eyewash and emergency showers in the work area.

Recognizing a hazardous drug spill means switching to your facility's spill procedure and your assigned role in it. The details of that procedure are facility-specific.

Controlled-substance breakage

Compare a different kind of "spill." A technician drops and breaks a bottle of a controlled liquid, and a coworker sees it happen. DEA says witnessed breakage is not a loss that requires notifying DEA, because the pharmacy can account for it.

Recordkeeping for destroyed controlled substances still applies. Theft or unexplained loss is a different situation, covered in Controlled inventory, ordering and losses.

Sharps

Plain meaning: sharps are objects that can puncture or cut skin. They go into a puncture-resistant container, never the trash or the toilet.

Sharps include:

• needles and syringes
• lancets
• auto-injectors, including epinephrine and insulin pens
• infusion sets
• connection needles

Used sharps go into a sharps disposal container right away. In healthcare facilities, these containers are made of rigid, puncture-resistant plastic or metal. They have leak-resistant sides and bottom and a lid opening too small for a hand.

Rules for using a sharps container:

• Fill line. Each container has a line marking about three-quarters full. At that point, close and seal it following the manufacturer's instructions. Then follow the facility's policy and the medical waste vendor's instructions.
• Full containers. Never open, empty or manually clean a full container.
• Non-sharps waste. Do not put other waste in a sharps container.
• Loose sharps. Never put loose sharps in trash or recycling bins, and never flush them.

Question 9

A delivery tote of a drug on your facility's hazardous drug list arrives with a cracked, leaking vial. A coworker grabs paper towels. What should you recognize, and why?

After an accidental used-sharp injury

Plain meaning: being stuck by someone else's used needle is a possible exposure to bloodborne infections such as hepatitis B, hepatitis C and HIV. Medical evaluation is needed right away. Disposal steps do not substitute for care.

Take these steps:

1. Wash the puncture or cut right away with soap and water. FDA also lists a skin antiseptic, such as rubbing alcohol or hand sanitizer, as an option.
2. Flush or rinse any other splashes. Flush splashes to the nose, mouth or skin with water. Rinse eyes with clean water, saline or sterile irrigation fluid.
3. Report the incident to your supervisor right away and complete the incident report.
4. Seek medical care immediately to assess the risk from the exposure.

Whether to give post-exposure treatment, called post-exposure prophylaxis or PEP, is a clinical decision made by medical providers. Neither the technician nor a coworker decides it.

Information that helps the report includes:

• the date and time of the injury
• what you were doing when it happened
• the type of device, including brand and model if known

Worked example: a lancet in the returns bin

A technician sorting a returns bin is stuck by a used lancet. There is no visible blood on the lancet and the puncture is tiny.

Correct response: wash, report to the supervisor and get medical care right away.

The tempting mistake is to decide the stick "doesn't count" because no blood was visible. The guidance applies to any accidental stick from another person's used sharp. The absence of a few visible warning signs does not show the exposure is low-risk. That assessment belongs to medical care.

Change one fact: the needle was brand-new and unused, still in its package, and only scratched the skin. That is not a stick from someone else's used sharp, so it is not the exposure situation described above. Still report any injury under your facility's policy.

The second tempting mistake is to treat "I put the lancet in the sharps container" as the response. Containing the device is a disposal step. It is not treatment and not reporting.

Question 10

After a needlestick from a used syringe, a technician washes the area, puts the syringe in the sharps container, and goes back to work, planning to mention it at the end of the shift. What is missing?

Independent practice

Question 11

A long-term care facility wants to deposit a deceased resident's schedule III tablets into a retail pharmacy's collection receptacle across town. Which part of this plan raises an eligibility question?

Question 12

A pharmacy wants to start a take-back kiosk next week. It has a sturdy locked box and plans to place it by the front door, away from the counter, so customers can use it 24 hours a day. Identify the problems.

Question 13

A pharmacy's state law adds a disposal requirement beyond the federal rules. A coworker says, "We meet DEA's rules, so state law doesn't matter." Respond.

Question 14

Sort each item into its correct disposal route.

• (a) The pharmacy's expired schedule II stock, using a reverse distributor
• (b) A patient's own leftover schedule IV medicine
• (c) A sealed sharps container at its fill line
• (d) A recalled schedule III lot the manufacturer is collecting

What to remember

• Ask three separate questions: worker hazard (NIOSH), environmental waste (EPA hazardous waste), and accountability (DEA controlled status). One answer never settles another. A product missing from the facility's hazardous drug list is not automatically cleared; check current product hazard information and your facility's procedure.
• Waste status can depend on the formulation. Alcohol percentage alone does not prove a liquid is ignitable: ignitability turns on flash point and the exact formulation, and the facility makes the waste determination. A liquid confirmed as ignitable may have a tablet counterpart that is not.
• A P- or U-listing does not cover every discarded product containing a named chemical. It applies to unused commercial chemical products, including formulations where the listed chemical is the sole active ingredient, when the listing conditions hold.
• Pharmacies may not flush hazardous waste medicines. The FDA Flush List applies to households, not pharmacies.
• The owner decides the route. Pharmacy stock never goes into take-back. Patients deposit their own medicine themselves.
• Controlled pharmacy stock leaves by one of four routes: on-site destruction to a non-retrievable result with Form 41, a reverse distributor (which issues Form 222 for schedule II), return or recall to an authorized registrant, or Special Agent in Charge assistance via Form 41. Never send drugs to DEA without prior approval.
• Collection receptacles require DEA authorization, accept only eligible depositors and items, stay near staffed areas, lock when unstaffed, need two employees for liner changes, and are never sorted or counted.
• Hazardous drug spills need the facility's prepared spill response. Sharps go into puncture-resistant containers that are sealed at the fill line and never emptied.
• After a stick from a used sharp: wash, report and get medical care right away. Disposal is not treatment.

Review: Household collection has an eligible stream

• Whose medicine is it? Pharmacy inventory versus household take-back

Review: Direct deposit is not a counter handoff

• The collection receptacle: who, what, and how access is controlled

Review: Destruction must prevent recovery for use

• Controlled pharmacy stock: four authorized pathways

Review: A return or recall has a recipient boundary

• Controlled pharmacy stock: four authorized pathways